AzTrials
AzTrials

Ulcerative ColitisPhase 3FIGARO UC 302NCT03259308

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 study testing Ontamalimab in people with Ulcerative Colitis, run by Shire at 207 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Ontamalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
207 sitesin 22 countries
Study dates
5 Dec 2017to 6 Oct 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
  • Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index (BMI) >=16.5 kilogram per square metre (kg/m^2).
  • Participants must have a documented diagnosis of UC for >=3 months before screening. The following must be available in each participant's source documentation:
  • A biopsy report to confirm the histological diagnosis. b. A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
  • Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy, including biopsy sample collection, during screening after all other inclusion criteria have been met.
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  • Participants must have moderate to severe active UC, defined as a total Mayo score of >=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1, and stool frequency subscore >=1 at baseline.
  • Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
  • Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).
  • Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
  • Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

Who cannot join

  • Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
  • Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
  • Participants with past medical history or presence of toxic megacolon.
  • Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
  • Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
  • Participants at risk for colorectal cancer include, but are not limited to:
Show all 63Show fewer
  • Participants with extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of age.
  • Participants >=50 years of age at the time of signing of the informed consent form.
  • Participants have had prior treatment with ontamalimab (formerly PF-00547659, SHP647).
  • Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
  • Participants have received anti-TNF treatment within 60 days before baseline.
  • Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.
  • Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.
  • Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
  • Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
  • Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.
  • Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.
  • Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.
  • Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [Participants with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.
  • Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy.
  • Participants with evidence of active or latent infection with Mycobacterium TB or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon gamma release assay (IGRA) performed.
  • Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.
  • An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.
  • If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent TB, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.
  • Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action). This consultation must be included in source documentation.
  • Results from a chest x-ray, taken within the 12 weeks before or during screening must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist.
  • Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met:
  • The participant has previously received an adequate course of treatment for either latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale where rates of primary multidrug TB resistance are <5%. Participants from regions with higher rates of primary multidrug TB resistance are excluded) or active (acceptable multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included in source documentation. Consultation with a pulmonary or infectious disease specialist to confirm adequate treatment (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action) must be performed during the screening period. The consultation report must be included in source documentation prior to enrollment.
  • A chest x-ray performed within 12 weeks before screening or during screening indicates no evidence of active or recurrent disease, and documentation of interpretation by a qualified medical specialist must be included in source documentation.
  • Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
  • Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
  • Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
  • Participants with a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:
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  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.
  • Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
  • Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening.
  • History of significant cerebrovascular disease within 24 weeks before screening.
  • Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.
  • Participants with evidence of cirrhosis with or without decompensation.
  • Participants with primary sclerosing cholangitis.
  • Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).
  • Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory.
  • Participants with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and HCVRNA).
  • Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCVRNA at least 12 weeks prior to baseline]).
  • Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening.
  • Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.
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  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper limit of normal (ULN).
  • Total bilirubin level >=1.5×ULN or >2.0×ULN if the participant has a known documented history of Gilbert's syndrome.
  • Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
  • Platelet count <=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3]) or >=1000×10^9/L (1,000,000 cells/mm^3).
  • White blood cell count <=3.5×10^9/L (3500 cells/mm^3).
  • Absolute neutrophil count (ANC)<2×10^9/L (2000 cells/mm^3).
  • Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
  • Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
  • Participants with known human immunodeficiency virus (HIV) infection based on documented history, with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.
  • Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated.
  • Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind, including abuse of medical marijuana (cannabis).
  • Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Female participants who are planning to become pregnant during the study period.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who are investigational site staff members or relatives of those site staff members or Participants who are Shire employees directly involved in the conduct of the study.

Trial locations and contacts

207 sites in 22 countries.

207 sites in 22 countries

United States62 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Infinite Clinical Trials

    Atlanta, Georgia, 30349

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts, 02302

  • Renaissance Research Medical Group, INC

    Cape Coral, Florida, 33991

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Loretto Hospital

    Chicago, Illinois, 60644

  • Gastro Florida

    Clearwater, Florida, 33756

  • Hi Tech and Global Research, LLc

    Coral Gables, Florida, 33134

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia, 30033

  • United Medical Doctors

    Encinitas, California, 92024

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Mid Atlantic Health Specialists

    Galax, Virginia, 24333

  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

    Garland, Texas, 75044

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • IL Gastroenterology Group

    Gurnee, Illinois, 60031

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41701

  • Edward Hines Jr VA Hospital - NAVREF - PPDS

    Hines, Illinois, 60141

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Precision Research Institute, LLC

    Houston, Texas, 77039

  • Biopharma Informatic Inc.

    Houston, Texas, 77043

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Aztec Medical Research

    Houston, Texas, 77079

  • BI Research Center

    Houston, Texas, 77084

  • ENCORE Borland-Groover Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32256

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546

  • SIH Research

    Kissimmee, Florida, 34741

  • Mayo Clinic Health System - PPDS

    La Crosse, Wisconsin, 54601

  • University of California San Diego

    La Jolla, California, 92037

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Alliance Medical Research LLC

    Lighthouse PT, Florida, 33064

  • VA Long Beach Healthcare System - NAVREF - PPDS

    Long Beach, California, 90822

  • Ohio Clinical Research Partners LLC

    Mentor, Ohio, 44060

  • Arizona Digestive Health Mesa - East

    Mesa, Arizona, 85206

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33065

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • United Medical Doctors

    Murrieta, California, 92563

  • Pharma Research International Inc

    Naples, Florida, 34110

  • Bayside Clinical Research - New Port Richey

    New Port Richey, Florida, 34655

  • Weill Cornell Medical College

    New York, New York, 10021

  • Encompass Care

    North Las Vegas, Nevada, 89086

  • Dupage Medical Group

    Oakbrook Terrace, Illinois, 60181

  • Veteran's Research and Education Foundation - NAVREF - PPDS

    Oklahoma City, Oklahoma, 73104

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York, 14127

  • Elite Clinical Studies - Phoenix - Clinedge - PPDS

    Phoenix, Arizona, 85018

  • Accel Research Sites - St. Petersburg - ERN - PPDS

    Pinellas Park, Florida, 33781

  • Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

    Pittsburgh, Pennsylvania, 15240

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

  • Alliance Clinical Research-(Vestavia Hills)

    Poway, California, 92064

  • Southern Star Research Institute LLC

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94158

  • Care Access Research, San Pablo

    San Pablo, California, 94806

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • St Louis Center For Clinical Research

    St Louis, Missouri, 63128

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • DBC Research

    Tamarac, Florida, 33321

  • Winchester Gastroenterology Associates

    Winchester, Virginia, 22601

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Ukraine27 sites

  • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, Chernivtsi Oblast, 58001

  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

    Dnipro, 49005

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49038

  • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

    Dnipro, 49074

  • Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

    Kharkiv, Kharkiv Oblast, 61037

  • Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine

    Kharkiv, 61039

  • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

    Kharkiv, 61166

  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

    Kherson, 73000

  • Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council

    Kryvyi Rih, 50056

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023

  • Kyiv City Clinical Hospital #18

    Kyiv, 01030

  • Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

    Kyiv, 01033

  • Municipal Institution of KRC Kyiv Regional Hospital #2

    Kyiv, 04073

  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway

    Lviv, 79007

  • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

    Lviv, 79059

  • Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

    Odesa, 65025

  • MNPE Central City Clinical Hospital of Uzhhorod City Council

    Uzhhorod, 88000

  • Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1

    Vinnytsia, Vinnytsia Oblast, 21001

  • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

    Vinnytsia, Vinnytsia Oblast, 21018

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, 21009

  • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

    Vinnytsia, 21018

  • City Clinical Hospital #1

    Vinnytsia, 21029

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"

    Vinnytsia, 21029

  • Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, 69000

  • MNPE City Hospital No. 6 of Zaporizhzhia City Council

    Zaporizhzhya, 69035

Other trials in Ukraine

Japan17 sites

  • Kunimoto Hospital

    Asahikawa, 070-0061

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Medical Corporation Aoyama Clinic

    Kobe, Hyôgo, 650-0015

  • Aizawa Hospital

    Matsumoto-shi, 390-0814

  • Hyogo College of Medicine

    Nishinomiya-shi, Hyôgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823

  • Chiinkai Dojima General & Gastroenterology Clinic

    Osaka, 530-0003

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Yodogawa Christian Hospital

    Osaka, 533-0024

  • Bellland General Hospital

    Sakai, 599-8247

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543

  • Tohoku Rosai Hospital

    Sendai, 981-8563

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293

  • Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

    Takatsuki, 569-0086

  • Nihonbashi Egawa Clinic

    Tokyo, 103-0028

  • Koukokukai Ebisu Clinic

    Tokyo, 150-0013

Other trials in Japan

South Korea16 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyungpook National University Chilgok Hospital

    Daegu, 702-210

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggido, 13496

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center PPDS

    Seoul, 06351

  • Inje University Seoul Paik Hospital

    Seoul, 100-032

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggido, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gang'weondo, 26426

Other trials in South Korea

Bulgaria13 sites

  • University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv, 4004

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

    Rousse, 7002

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, 5400

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, Sofia-Grad, 1202

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, Sofia-Grad, 1431

  • University Multiprofile Hospital for Active Treatment Sveta Anna

    Sofia, Sofia-Grad, 1750

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad, 1784

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1000

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Medical Center Convex EOOD

    Sofia, 1680

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9000

Other trials in Bulgaria

Hungary12 sites

  • Bekes Megyei Kozponti Korhaz

    Békéscsaba, 5600

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1136

  • ENDOMEDIX Kft.

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz

    Gyula, 5700

  • Mohacsi Korhaz

    Mohács, 7700

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa János Kórház

    Szekszárd, 7100

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, 6600

  • Jávorszky Ödön Kórház

    Vác, 2600

  • Csolnoky Ferenc Korhaz

    Veszprém, 8200

Other trials in Hungary

Mexico11 sites

  • Centro de Investigación Médica Aguascalientes

    Aguascalientes, 20116

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, 54769

  • Clinica de Higado y Gastroenterologia Integral, S.C.

    Cuernavaca, Morelos, 62170

  • JM Research S.C

    Cuernavaca, Morelos, 62290

  • Centro de Investigacion Clinica Acelerada, S.C.

    Distrito Federal, 07020

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, Yucatán, 97000

  • Health Pharma Professional Research S.A de C.V.

    Mexico City, Mexico City, 03810

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000

  • Clinical Research Institute

    Tlalnepantla, 54055

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

Spain10 sites

  • Centro Medico Teknon - Grupo Quironsalud

    Barcelona, 08022

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital Senhora da Oliveira - Guimaraes, E.P.E

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338

  • Hospital de São Bernardo

    Setúbal, 2910-446

Other trials in Portugal

Belgium4 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • UZ Gasthuisberg

    Leuven, Vlaams Brabant, 3000

  • CHU Mouscron

    Mouscron, 7700

Other trials in Belgium

Colombia4 sites

  • Fundación Clínica Shaio

    Bogota, Cundinamarca, 111121

  • Servimed S.A.S

    Bucaramanga, Santander Department, 680003

  • IPS Centro Médico Julián Coronel S.A.S. - PPDS

    Cali

  • Hospital Pablo Tobón Uribe

    Medellín, Antioquia, 050034

Other trials in Colombia

Greece4 sites

  • Ippokrateio General Hospital of Athens

    Athens, Attica, 11527

  • University General Hospital of Patras

    Pátrai, 26504

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54007

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

New Zealand4 sites

  • Dunedin Hospital

    Dunedin, South Island, 9016

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Argentina3 sites

  • Fundación Favaloro

    Buenos Aires, C1093AAS

  • Hospital Privado Centro Médico de Córdoba

    Córdoba

  • Sanatorio 9 de Julio SA

    San Miguel de Tucumán, Tucumán Province, T4000DGI

Other trials in Argentina

Estonia3 sites

  • East Viru Central Hospital

    Kohta-Järve, 31025

  • OÜ LV Venter

    Pärnu, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Slovakia3 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 851 07

  • KM Management, spol. s r.o.

    Nitra, 949 01

  • Gastro LM, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Canada2 sites

  • Toronto Digestive Disease Associates Inc

    Toronto, Ontario, M3N 2V7

  • Percuro Clinical Research LTD

    Victoria, British Columbia, V8P 2P5

Other trials in Canada

Lebanon2 sites

  • Rafik Hariri University Hospital

    Beirut

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Turkey (Türkiye)2 sites

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Mersin University Medical Faculty

    Mersin, 33169

Other trials in Turkey (Türkiye)

Bosnia and Herzegovina1 site

  • Clinical Center Banja Luka

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

Ireland1 site

  • St Vincent's University Hospital

    Dublin, Dublin 4

Other trials in Ireland

Switzerland1 site

  • Universität Zürich

    Zurich, Zürich (de), 8091

Other trials in Switzerland

About this study

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Read the detailed description

27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Being tested
Ontamalimab, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OntamalimabDrug

    Also called SHP647, PF- 00547659

    Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

  • PlaceboDrug

    Participants will receive 1 mL of sterile aqueous buffered solution.

Study groups in NCT03259308
Study groupRoleWhat they receive
Ontamalimab 25 mgExperimentalParticipants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.
Receives: Drug: Ontamalimab
Ontamalimab 75 mgExperimentalParticipants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.
Receives: Drug: Ontamalimab
PlaceboPlacebo comparatorParticipants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Remission Based on Composite Score at Week 12

    Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure derived from the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

Secondary outcomes (23)

  1. Number of Participants With Endoscopic Remission at Week 12

    Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 12

  2. Number of Participants With Clinical Remission at Week 12

    Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score ranged from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 12

  3. Number of Participants With Clinical Response Based on Composite Score at Week 12

    Clinical response based on composite score was defined as a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub-score for rectal bleeding greater than or equal to (>=) 1 point or a sub-score for rectal bleeding less than or equal to (<=) 1. The composite score was a recommended measure derived from the Mayo score without the PGA sub-score and ranged from 0 to 9 points. The Mayo score was a measure of UC disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  4. Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12

    Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excluded friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 equal to (=) structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease. Number of participants with mucosal healing based on endoscopic and histological assessment using the Geboes score grading system were reported.

    Measured: At Week 12

  5. Number of Participants With Remission Based on Total Mayo Score at Week 12

    Remission was defined as a Total Mayo score of <=2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excluded friability], and PGA) exceeding 1, at the Week 12. The Total Mayo score ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  6. Number of Participants With Clinical Response Based on Total Mayo Score at Week 12

    Clinical response (Mayo) was defined as a decrease from baseline in the Total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or an absolute sub-score for rectal bleeding <=1. The Total Mayo score ranged from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).

    Measured: At Week 12

  7. Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12

    The partial Mayo score ranged from 0 to 9 points and consisted of the following 3 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Stool frequency (0-3); Rectal bleeding (0-3); PGA (0-3). The partial Mayo score did not include the endoscopy sub-score.

    Measured: At Weeks 4, 8, and 12

  8. Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8

    Number of participants were reported with stool frequency sub-scores of 0 or 1 and rectal bleeding sub-score of 0. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline in stool frequency sub-score, and a rectal bleeding sub-score of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Weeks 4 and 8

  9. Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12

    Endoscopic remission was defined by centrally read endoscopic sub-score 0 (modified, excluded friability). The centrally read endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 12

  10. Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12

    Number of participants were reported with rectal bleeding and stool frequency sub-scores of 0. Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. The stool frequency sub-score and rectal bleeding sub-score of Mayo score ranges from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Weeks 4, 8, and 12

  11. Number of Participants With Deep Remission at Week 12

    Deep remission was defined as both endoscopic and rectal bleeding sub-scores of 0, and stool frequency sub-score <=1 and a centrally read Geboes score of <=2. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of Mayo score ranged from 0 to 3 with higher scores indicating more severe disease. The composite score was a recommended measure consisted of the Mayo score without the PGA sub-score and ranged from 0 to 9 points. Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicating more severe disease.

    Measured: At Week 12

  12. Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12

    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data of abdominal pain worst severity, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or non-consecutive) of last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Abdominal pain's worst severity assessment was based on an 11-point numerical rating scale with 0 anchor at "No pain" and 10 at "Worst Imaginable Pain" as experienced over the previous 24 hours, in the e-diary. Higher scores indicating more severe pain.

    Measured: Baseline, Week 12

  13. Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of loose bowel movement, as experienced over the previous 24 hours, in the e-diary. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number of loose bowel movement ranged from 0-27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  14. Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for number of bowel movement with urgency, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements urgency ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  15. Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements ranged from 0 to 27. Higher scores indicating more frequent bowel movements.

    Measured: Baseline, Week 12

  16. Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12

    PRO-UC signs and symptom data were collected using a daily e-diary during treatment period. Collection of daily e-diary data was begun at least 10 days before the baseline visit. Participants were asked to record the signs and symptom data for average number of bowel movements with blood, as experienced over the previous 24 hours. Participant's signs and symptom average scores at each scheduled visit were calculated based on data recorded over the most recent 3 days (consecutive or nonconsecutive) of the last 10 days prior to the scheduled visit start date excluding the following days: day of any bowel preparation, day of endoscopy, any days between day of bowel preparation and day of endoscopy, and the 2 days after the day of endoscopy. Average number bowel movements with blood ranged from 0 to 27. Higher scores indicating more frequent bowel movements with blood.

    Measured: Baseline, Week 12

  17. Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12

    Total sign/symptom score was the average of the average scores of worst abdominal pain over the past 24 hours and the conversion scale values for number of bowel movements blood, number of bowel movements with urgency, number of bowel movements and number of loose bowel movements, with scale ranged of 0-10, with higher scores indicating higher severity.

    Measured: Baseline, Week 12

  18. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12

    IBDQ was a psychometrically validated participant-reported outcome (PRO) instrument for measuring the disease-specific health-related quality of life (HRQL) in participants with inflammatory bowel disease, including UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. Higher scores indicating a better quality of life.

    Measured: Baseline, Weeks 8 and 12

  19. Change From Baseline in IBDQ Total Scores at Weeks 8 and 12

    IBDQ was a psychometrically validated PRO instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, included UC. The IBDQ consisted of 32 items, which were grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The 4 domains were scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicating better HRQL. A score of at least 170 corresponds to clinical remission and an increase of at least 16 points was considered to indicate a clinically meaningful improvement.

    Measured: Baseline, Weeks 8 and 12

  20. Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12

    SF-36 was a generic quality-of-life instrument that had been widely used to assess health-related quality of life (HRQL) of participants. SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]). Four domains comprised physical component summary (PCS) score (physical functioning, role-physical, bodily pain, general health) and remaining 4 domains comprised mental component summary (MCS) score (vitality, social functioning, role-emotional, mental health). The scores ranged from 0 to 100. Higher scores indicating better HRQL.

    Measured: Baseline, Week 12

  21. Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12

    SF-36 was a generic quality-of-life instrument that had been widely used to assess HRQL of participants. Generic instruments were used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consisted of 36 items that were aggregated into 8 multi-item scales (physical functioning [1=yes, limited a lot to 3=no, not limited at all], role-physical [1=all of the time to 5=none of the time], bodily pain [1=very severe to 6=none], general health [1=poor to 5=excellent], vitality [1=none of the time to 5=all of the time], social functioning [1=all of the time: to 5=none of the time], role emotional [1=all of the time to 5=none of the time] and mental health [1=all of the time to 5=none of the time]), with scores ranged from 0 to 100. Higher scores indicating better HRQL.

    Measured: Baseline, Week 12

  22. Number of Participants Based on Inpatient Hospitalization

    Number of participants based on inpatient hospitalization due to all-cause hospitalization, gastrointestinal related, other illness/problem, and undergo gastrointestinal related procedures during the entire study period were reported.

    Measured: From start of study up to follow up (Week 29)

  23. Median Duration of Total Inpatient Days

    Inpatient days were calculated as Date of discharge - Date of admission + 1. Median duration of total inpatient days during the entire study period was reported.

    Measured: From start of study up to follow-up (Week 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start5 Dec 2017
  3. Primary completion15 Jul 2020
  4. Study completion6 Oct 2020

Why it stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
279 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259308
Sponsor's protocol ID
SHP647-302
Other IDs
2017-000572-28, 2017
Acronym
FIGARO UC 302
Status last verified
Mar 2021
First submitted
21 Aug 2017
Last updated
26 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ontamalimab in people with Ulcerative Colitis, run by Shire at 207 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 63 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Ukraine, Japan, South Korea, Bulgaria and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Remission Based on Composite Score at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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