AzTrials
AzTrials

Moderate to Severe Ulcerative ColitisPhase 2NCT04090411

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

A Phase 2 study testing Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W and Induction- PF-06480605 450 mg SC Q4W in people with Moderate to Severe Ulcerative Colitis, run by Hoffmann-La Roche at 166 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Moderate to Severe Ulcerative Colitis
What is being tested?
Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W and Induction- PF-06480605 450 mg SC Q4W
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
246 participants
Where
166 sitesin 23 countries
Study dates
19 Dec 2019to 25 Oct 2022
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of UC for >=3 months.
  • Participants with moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2.
  • Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
  • Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.

Who cannot join

  • Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
  • Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
  • Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
  • 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
  • Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

Trial locations and contacts

166 sites in 23 countries.

166 sites in 23 countries

United States55 sites

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital - Office

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Medycal Research Inc.

    Brooksville, Florida, 34613

  • The University of Chicago Medical Center (clinic address)

    Chicago, Illinois, 60637

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Safety Harbor Surgery

    Clearwater, Florida, 33761

  • Trident Care

    Clearwater, Florida, 33762

  • Digestive Health Specialists

    Dothan, Alabama, 36301

  • Dothan Surgery Center

    Dothan, Alabama, 36301

  • Flowers Hospital

    Dothan, Alabama, 36305

  • Gastroenterology Associates of Northern VA

    Fairfax, Virginia, 22031

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • Michigan Endoscopy Center

    Farmington Hills, Michigan, 48334

  • Gastroenterology Associates, PA of Greenville

    Greenville, South Carolina, 29607

  • Endoscopy Center of Connecticut, LLC

    Guilford, Connecticut, 06437

  • Endoscopy Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Medical Research Center Of Connecticut, LLC

    Hamden, Connecticut, 06518

  • PACT Gastroenterology Center

    Hamden, Connecticut, 06518

  • Whitney Imaging

    Hamden, Connecticut, 06518

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Valley View Surgery Center

    Las Vegas, Nevada, 89102

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72204

  • Vanderbilt GI Endoscopy Lab at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt Heart One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt Inflammatory Bowel Disease Clinic

    Nashville, Tennessee, 37204

  • Vanderbilt Laboratory Services North One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt One Hundred Oaks Imaging

    Nashville, Tennessee, 37204

  • Vanderbilt University Medical Center - GI Research Office

    Nashville, Tennessee, 37212-1610

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Vanderbilt University Med. Center

    Nashville, Tennessee, 37232-5543

  • Vanderbilt University Medical Center- Heart Station (ECG)

    Nashville, Tennessee, 37232

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10021

  • New York Presbyterian Hospital - Weill Cornell Medical Center

    New York, New York, 10065

  • Weill Cornell Medical College - New York Presbyterian Hospital

    New York, New York, 10065

  • Weill Cornell Medical College- New York Presbyterian Hospital

    New York, New York, 10065

  • Surinder Saini, M.D., Inc.

    Newport Beach, California, 92660

  • Tower Radiology Center

    Oldsmar, Florida, 34677

  • Investigational Drug Services

    Philadelphia, Pennsylvania, 19104

  • Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Gastroenterology Consultants P.C.

    Roswell, Georgia, 30076

  • Gastroenterology Consultants of San Antonio, PA

    San Antonio, Texas, 78230

  • VIP Trials

    San Antonio, Texas, 78230

  • South Texas Radiology Imaging Centers

    San Antonio, Texas, 78258

  • Akumin

    Tampa, Florida, 33603

  • Tampa Bay Endoscopy Center

    Tampa, Florida, 33603

  • Alliance Clinical Research of Tampa

    Tampa, Florida, 33615

  • Medical Diagnostic Imaging

    Wauwatosa, Wisconsin, 53222

  • Allegiance Internal Medicine and Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • GI Associates

    Wauwatosa, Wisconsin, 53226

Other trials in United States

Russia12 sites

  • KDC "Evromedservis", OJSC

    Moscow, 115419

  • Limited Liability Company "Medicinsky Center SibNovoMed"

    Novosibirsk, 630005

  • LLC Novosibirskiy Gastrocenter

    Novosibirsk, 630007

  • Clinic of OSMU

    Omsk, 644050

  • Perm Clinical Centre of the Federal Medical-Biological Agency

    Perm, 614109

  • Pyatigorsk City Clinical Hospital

    Pyatigorsk, Stavropol Kray, 357500

  • Private Healthcare Institution "Clinical Hospital" Russian Railways-Medicine "Samara city"

    Samara, 443029

  • Clinical Hospital named after S.R. Mirotvortsev

    Saratov, 410054

  • Research Institute of Antimicrobial Chemotherapy

    Smolensk, 214019

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • City Hospital JSC "Medical centre"

    Tyumen, 625007

  • SBHI YaR "Regional Clinical Hospital"

    Yaroslavl, 150062

Other trials in Russia

South Africa10 sites

  • Dr van Dyk & Partners Inc

    Bloemfontein, Free State, 9301

  • IATROS International

    Bloemfontein, Free State, 9301

  • Universitas Private Hospital

    Bloemfontein, Free State, 9301

  • Ahmed Kathrada Private Hospital

    Johannesburg, Gauteng, 1827

  • Lenasia Clinical Trial Centre

    Johannesburg, Gauteng, 1827

  • Arwyp Medical Centre

    Kempton Park, Gauteng, 1619

  • Clinresco Centres (Pty) Ltd

    Kempton Park, Gauteng, 1619

  • Emmed Research

    Pretoria, Gauteng, 0002

  • Radiology24 Jakaranda Hospital

    Pretoria, Gauteng, 0002

  • Mediclinic Kloof Hospital

    Pretoria, Gauteng, 0048

Other trials in South Africa

Hungary8 sites

  • Magyar Imre Kórház

    Ajka, 8400

  • DRC Gyogyszervizsgalo Kozpont Kft.

    Balatonfüred, Veszprém megye, 8230

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, H-1033

  • Life Egészségcentrum

    Székesfehérvár, 8000

  • Clinfan Kft.

    Szekszárd, 7100

  • Deák Jenő Kórház

    Tapolca, 8300

  • Clinexpert Tatabanya, Szent Borbala Hospital

    Tatabánya, H-2800

  • Szofia Private Clinic

    Veszprém, 8200

Other trials in Hungary

Japan8 sites

  • Tokyo Medical And Dental University Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Aichi Medical University Hospital

    Nagakute, Aichi-ken, 480-1195

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

Other trials in Japan

Poland8 sites

  • KLIMED Marek Klimkiewicz

    Bialystok, 15-704

  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

  • MZ Badania Slowik Zymla Sp. j.

    Knurów, 44-190

  • ENDOSKOPIA Sp. z o. o.

    Sopot, 81-756

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • NZOZ Vivamed Jadwiga Miecz

    Warsaw, 03-580

  • Centrum Medyczne Melita Medical

    Wroclaw, 50-449

Other trials in Poland

Ukraine8 sites

  • Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"

    Kharkiv, 61024

  • Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"

    Kharkiv, 61037

  • Medical Centre Medical Clinic Blagomed LLC

    Kyiv, 01023

  • Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"

    Kyiv, 02091

  • Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"

    Kyiv, 04078

  • Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"

    Kyiv, 04107

  • Medical center of Limited Liability Company "Health Clinic", medical clinical research center

    Vinnytsia, 21009

  • Medical Centre "DIACENTER" LLC

    Zaporizhzhya, 69076

Other trials in Ukraine

France7 sites

  • CHU d'Amiens-Picardie - SITE SUD

    Amiens, 80054

  • Centre Hospitalier Regional Universitaire (CHU) de Lille - CIC

    Lille, 59037

  • Centre Hospitalier Regional Universitaire (CHU) de Lille - Hopital Claude Huriez

    Lille, 59037

  • Centre Hospitalier Regional Universitaire (CHU) de Lille

    Lille, 59037

  • CHU Hôtel-Dieu

    Nantes, 44093

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

India7 sites

  • M.S. Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560054

  • S.R. Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • S.M.S. Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Grant Medical Foundation, Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Shree Giriraj Multispeciality Hospital

    Rajkot, Gujarat, 360005

  • Surat Institute of Digestive Sciences

    Surat, Gujarat, 395002

  • Gujarat Hospital Gastro and Vascular Centre, Opp. Shree Ram Petrol Pump

    Surat, Gujarat, 395009

Other trials in India

United Kingdom7 sites

  • MeDiNova Northamptonshire Quality Research Site

    Corby, NN18 9EZ

  • Egin Research Ltd

    High Wycombe, HP11 2QW

  • MeDiNova North London Quality Research Site

    Northwood, Middlesex, HA6 2RN

  • Chest X-ray Facility - BMI Bishops Wood Hospital

    Northwood, HA6 2JW

  • Spire Nottingham Hospital

    Nottingham, NG12 4GA

  • Endoscopy Facility - Orpington Endoscopy Centre

    Orpington, BR5 3TW

  • Endoscopy Facility - Spire Little Aston Hospital

    Sutton Coldfield, Birmingham, B74 3UP

Other trials in United Kingdom

Italy6 sites

  • IRCCS "Saverio de Bellis", UOC Gastroenterologia

    Castellana Grotte, BARI, 70013

  • A.O.U. dell'Università degli Studi della Campania "Luigi Vanvitelli"

    Naples, Naples, 80138

  • UO Malattie retto-Intestinali Ospedale "Sacro Cuore-don Calabria"

    Negrar, Verona, 37024

  • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia

    Padova, 35128

  • Policlinico Universitario Campus Bio-Medico di Roma

    Roma, RM, 00128

  • Istituto Clinico Humanitas Centro per le Malattie Infiammatorie Croniche dell'Intestino - IBD Cent

    Rozzano, Milan, 20089

Other trials in Italy

Turkey (Türkiye)5 sites

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093

  • Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali

    Kocaeli, 41380

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33110

  • Bulent Ecevit Universitesi Tip Fakultesi

    Zonguldak, 67600

Other trials in Turkey (Türkiye)

Mexico4 sites

  • BRCR Global Mexico

    Guadalajara, Jalisco, 44600

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion

    Mérida, Yucatán, 97130

  • Karla Adriana Espinosa Bautista

    Mexico City, 01120

  • Smiq S. de R.L. de C.V.

    Querétaro, 76070

Other trials in Mexico

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Mater Misericordiae Ltd.

    South Brisbane, Queensland, 4101

Other trials in Australia

Germany3 sites

  • Deutsches Rotes Kreuz Schwesternschaft Berlin Gemeinnützige Krankenhaus GmbH

    Berlin, 14050

  • Studiengesellschaft BSF UG (haftungsbeschränkt)

    Halle, 06108

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle, 06108

Other trials in Germany

Serbia3 sites

  • Klinicki Centar Kragujevac

    Kragujevac, 34000

  • Opsta Bolnica Subotica

    Subotica, 24000

  • Opsta Bolnica "Djordje Joanovic", Odeljenje Interno, Odsek Gastroenterologija

    Zrenjanin, 23000

Other trials in Serbia

Slovakia3 sites

  • KM Management spol. s.r.o.

    Nitra, 949 01

  • Gastro LM s.r.o

    Prešov, 080 01

  • ENDOMED, s.r.o.

    Vranov nad Topľou, 093 01

Other trials in Slovakia

Thailand3 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Songklanagarind Hospital, Prince of Songkla University

    Hat Yai, Changwat Songkhla, 90110

  • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

Romania2 sites

  • Medlife S.A.

    Bucharest, 010719

  • Spitalul Clinic Colentina

    Bucharest, 020125

Other trials in Romania

Belgium1 site

  • University Hospitals Leuven/Department of Gastroenterology

    Leuven, 3000

Other trials in Belgium

Bulgaria1 site

  • "ACIBADEM City Clinic Diagnostic-Consultative Center" EOOD

    Sofia, 1784

Other trials in Bulgaria

Colombia1 site

  • Asociacion IPS Medicos Internistas de Caldas

    Manizales, Caldas Department, 170004

Other trials in Colombia

Spain1 site

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

Other trials in Spain

About this study

Official title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

Being tested
Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W, Induction- PF-06480605 450 mg SC Q4W, Induction- Placebo SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

What participants receive

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

  • Induction- PF-06480605 50 mg SC Q4WDrug

    PF-06480605

  • Induction- PF-06480605 150 mg SC Q4WDrug

    PF-06480605

  • Induction- PF-06480605 450 mg SC Q4WDrug

    PF-06480605

  • Induction- Placebo SC Q4WOther

    0 mg Placebo

  • Chronic- PF-06480605 50 mg SC Q4WDrug

    PF-06480605

  • Chronic- PF-06480605 150 mg SC Q4WDrug

    PF-06480605

  • Chronic- PF-06480605 450 mg SC Q4WDrug

    PF-06480605

Study groups in NCT04090411
Study groupRoleWhat they receive
Cohort 1ExperimentalInduction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W
Receives: Other: Induction- Placebo SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W
Cohort 2ExperimentalInduction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Receives: Other: Induction- Placebo SC Q4W; Drug: Chronic- PF-06480605 150 mg SC Q4W
Cohort 3ExperimentalInduction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Receives: Other: Induction- Placebo SC Q4W; Drug: Chronic- PF-06480605 450 mg SC Q4W
Cohort 4Placebo comparatorInduction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Receives: Drug: Induction- PF-06480605 50 mg SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W
Cohort 5ExperimentalInduction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Receives: Drug: Induction- PF-06480605 150 mg SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W
Cohort 6ExperimentalInduction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Receives: Drug: Induction- PF-06480605 150 mg SC Q4W; Drug: Chronic- PF-06480605 150 mg SC Q4W
Cohort 7ExperimentalInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W
Receives: Drug: Induction- PF-06480605 450 mg SC Q4W; Drug: Chronic- PF-06480605 50 mg SC Q4W
Cohort 8ExperimentalInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W
Receives: Drug: Induction- PF-06480605 450 mg SC Q4W; Drug: Chronic- PF-06480605 150 mg SC Q4W
Cohort 9ExperimentalInduction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W
Receives: Drug: Induction- PF-06480605 450 mg SC Q4W; Drug: Chronic- PF-06480605 450 mg SC Q4W

What is being measured

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

  1. Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14

    Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: At Week 14

  2. Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

    Measured: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)

  3. Induction Period: Number of Participants With Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

    Measured: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)

  4. Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.

    Measured: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)

  5. Chronic Period: Number of Participants With TEAEs

    TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

    Measured: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

  6. Chronic Period: Number of Participants With SAEs

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

    Measured: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

  7. Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation

    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.

    Measured: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)

Secondary outcomes (22)

  1. Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)

    Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: Induction Period: At Week 14; Chronic Period: At Week 56

  2. Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)

    Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: Induction Period: At Week 14; Chronic Period: At Week 56

  3. Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement

    Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: Induction Period: At Week 14; Chrnoic Period: At Week 56

  4. Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission

    Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: Induction Period: At Week 14; Chronic Period: At Week 56

  5. Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605

    Measured: Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)

  6. Induction Period: Change From Baseline in Fecal Calprotectin

    Measured: Baseline, Weeks 4, 8, and 12

  7. Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)

    Measured: Baseline, Weeks 4, 8, and 12

  8. Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)

    Measured: Baseline, Weeks 4, 8, and 12

  9. Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605

    Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.

    Measured: Baseline, Weeks 4, 8, 12, 14

  10. Chronic Period: Percentage of Participants Who Achieved Clinical Remission

    Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.

    Measured: At Week 56

  11. Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission

    Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.

    Measured: At Weeks 14 and 56

  12. Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)

    Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.

    Measured: At Weeks 14 and 56

  13. Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)

    Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.

    Measured: At Weeks 14 and 56

  14. Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement

    Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.

    Measured: At Weeks 14 and 56

  15. Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission

    Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.

    Measured: At Weeks 14 and 56

  16. Chronic Period: Change From Week 16 in Fecal Calprotectin

    Measured: Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64

  17. Chronic Period: Change From Week 14 in hsCRP

    Measured: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

  18. Chronic Period: Change From Week 14 in Serum sTL1A

    Measured: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

  19. Change From Baseline in Fecal Calprotectin Through the End of Study

    Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64

  20. Change From Baseline in hsCRP Through the End of Study

    Measured: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

  21. Change From Baseline in Serum sTL1A Through the End of Study

    Measured: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

  22. Chronic Period: Number of Participants With ADA and NAbs to PF-06480605

    Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.

    Measured: Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

Timeline

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

  1. First posted16 Sep 2019
  2. Study start19 Dec 2019
  3. Primary completion25 Oct 2022
  4. Study completion25 Oct 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04090411
Sponsor's protocol ID
XA45397
Other IDs
TL1A, Tuscany 2, 2019-002698-74, B7541007, 2019
Status last verified
Jun 2026
First submitted
12 Sep 2019
Last updated
17 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Danese S, Allegretti JR, Schreiber S, Peyrin-Biroulet L, Jairath V, D'Haens G, Kierkus J, Leong RW, Yarur AJ, Vincent MS, Banerjee A, Chandra DE, Peeva E, Neelakantan S, Hung KE, McBride JM, Bojic D, Lasch K, Schiffman C, Feagan BG. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):882-895. doi: 10.1016/S2468-1253(25)00129-3. Epub 2025 Jul 21.

    PubMed 40706613

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Induction- PF-06480605 50 mg SC Q4W, Induction- PF-06480605 150 mg SC Q4W and Induction- PF-06480605 450 mg SC Q4W in people with Moderate to Severe Ulcerative Colitis, run by Hoffmann-La Roche at 166 sites in 23 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Russia, South Africa, Hungary, Japan and 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Dec 2025). 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?

Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 (time frame: At Week 14). The study lists 7 primary outcomes in all. 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 NCT04090411, which also lists 1 linked publication.

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 17 Jul 2026.

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Clinical Trial NCT04090411 | AzTrials