AzTrials
AzTrials

Ulcerative ColitisPhase 2NCT04987307

Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2 study testing Efavaleukin alfa in people with Ulcerative Colitis, run by Amgen at 200 sites in 26 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 main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Efavaleukin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
200 sitesin 26 countries
Study dates
31 Jan 2022to 22 Oct 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant has provided informed consent prior to initiation of any study specific activities or procedures.
  • Men and women aged ≥ 18 to < 80 years at screening visit (≥ 19 to < 80 in South Korea).
  • Diagnosis of UC established ≥ 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. If a histopathology report is not available at screening, then additional biopsies may be taken during the screening period for local histopathology analysis to corroborate.
  • Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2.
  • Has documentation of:
  • A surveillance colonoscopy (performed according to local standard) within 12 months of day 1 visit for participants with pancolitis of > 8 years duration, or participants with left-sided colitis of > 12 years duration, or participants with primary sclerosing cholangitis.
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  • At the discretion of the investigator, a colonoscopy (instead of a rectosigmoidoscopy) may be performed as the screening endoscopy for this study.
  • For all other participants, up-to-date colorectal cancer surveillance (performed according to local standard). Participants who do not have a colonoscopy report available in source documentation will have a colonoscopy instead of rectosigmoidoscopy performed as the screening endoscopy for the study.
  • Participants must have demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy (ie, Janus kinase [JAK]-inhibitor or or S1P modulators), as follows:
  • Conventional therapy failed participants:
  • Corticosteroids (corticosteroid-refractory colitis, defined as signs and/or symptoms of active UC despite oral prednisone [or equivalent] at doses of at least 30 mg/day for a minimum of 2 weeks; or corticosteroid-dependent colitis, defined as: an inability to reduce corticosteroids below the equivalent of prednisone 10 mg/day within 3 months of starting corticosteroids without a return of signs and/or symptoms of active UC; or a relapse within 3 months of completing a course of corticosteroids).
  • History of intolerance of corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/ osteoporosis, hyperglycemia, or neuropsychiatric side-effects, including insomnia, associated with corticosteroid treatment).
  • Immunomodulators: signs and/or symptoms of persistently active disease despite at least 3 months treatment with one of the following at locally approved doses: oral azathioprine (eg, ≥ 1.5 mg/kg/day) or 6-mercaptopurine (eg, ≥ 0.75 mg/kg/day), or oral azathioprine or 6-mercatopurine within a therapeutic range as judged by thioguanine metabolite testing, or a combination of a thiopurine and allopurinol within a therapeutic range as judged by thioguanine metabolite testing.
  • History of intolerance to at least 1 immunomodulator (including but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, and lymphopenia) and have neither failed nor demonstrated an intolerance to a biological medication (anti-tumor necrosis factor [TNF] antibody, anti-integrin antibody, or interleukin [IL]-12/23 antagonists) that is indicated for the treatment of UC.
  • Biologic or targeted small molecule therapy failed participants: those who demonstrated inadequate response or loss of response or intolerance to biologic therapy for UC (eg, anti-TNF antibodies or IL-12/23 antagonists, anti-integrin antibodies) or targeted small molecules (eg, JAK inhibitors or S1P modulators). The therapy used to qualify the participant for entry into this category must be approved for the treatment of UC in the country of use, at the time of use. Participants must fulfil one of the following criteria:
  • Inadequate response: signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing that was indicated in the product label at the time of use.
  • Loss of response: recurrence of signs and symptoms of active disease during approved maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not quality as having failed or being intolerant to UC biological therapy, JAK inhibitor, or S1P modulators).
  • Intolerance: history of intolerance to infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib or other approved biologicals, JAK inhibitors or S1P modulators (including but not limited to infusion-related event, demyelination, congestive heart failure, or any other drug-related adverse event that led to a reduction in dose or discontinuation of the medication).
  • If receiving any of the following therapies, participants must have stable dosage for the specified duration:
  • 5-aminosalicylates (ASAs), stable dosage for ≥ 2 weeks prior to screening endoscopy.
  • Oral corticosteroids: prednisone ≤ 20 mg/day or its equivalent, stable dose for ≥ 2 weeks prior to screening endoscopy.
  • Budesonide: extended release tablets 9 mg/day [budensonide MMX], stable dose for ≥ 2 weeks prior to screening endoscopy.
  • Beclomethasone dipropionate: gastro-resistant prolonged-release tablet 5 mg/day, stable dose for >= 2 weeks prior to screening endoscopy.
  • Conventional immunomodulators: azathioprine, 6-mercaptopurine, methotrexate, stable dosage for ≥ 12 weeks prior to screening endoscopy.

Who cannot join

  • Diagnosis of Crohn's disease, inflammatory bowel disease unclassified (indeterminate colitis), microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease.
  • Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
  • Participant has had extensive surgery for UC (for example, subtotal colectomy), or is likely to require surgery for the treatment of UC during the study.
  • Currently receiving or had treatment within 12 months prior to screening with T cell depleting agents (eg, antithymocyte globulin, Campath).
  • Participant has received any of the following prescribed medication or therapy within the specified time period:
  • Anti TNF antibodies (eg, infliximab, adalimumab, golimumab) < 8 weeks prior to screening rectosigmoidoscopy.
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  • Anti integrin antibodies (eg, vedolizumab) < 8 weeks prior to screening rectosigmoidoscopy.
  • IL 12/23 antagonist (eg, ustekinumab) < 8 weeks prior to screening rectosigmoidoscopy.
  • JAK inhibitors (eg, tofacitinib) < 4 weeks prior to screening rectosigmoidoscopy.
  • Any other commercially approved biologic agent or targeted small molecule < 8 weeks prior to screening rectosigmoidoscopy or < 5 half lives prior to screening rectosigmoidoscopy, whichever is longer
  • Immunomodulatory medications, including oral cyclosporine, intravenous cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, thalidomide < 4 weeks prior to screening rectosigmoidoscopy.
  • Any investigational biologic therapy within 8 weeks prior to screening rectosigmoidoscopy or < 5 half-lives prior to screening rectosigmoidoscopy, whichever is longer.
  • Has used apheresis (eg, Adacolumnâ apheresis) < 2 weeks prior to screening rectosigmoidoscopy.

Trial locations and contacts

200 sites in 26 countries.

200 sites in 26 countries

United States63 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Harvard Medical School - Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Wake Research-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • West Central Gastroenterology

    Clearwater, Florida, 33756

  • Gastrointestinal Associates Research, LLC

    Columbia, Missouri, 65201

  • Columbia Digestive Health Research LLC

    Columbia, South Carolina, 29204

  • Columbus Regional Research Institute, LLC

    Columbus, Georgia, 31901

  • Southern California Research Center

    Coronado, California, 92118

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Sanmora Bespoke Clinical Research Solutions

    East Orange, New Jersey, 07018

  • Aga Clinical Research Associates LLC

    Egg Harbor, New Jersey, 08234

  • Great Lakes Research Insititute El Paso Research

    El Paso, Texas, 79912

  • Affiliates in Gastroenterology Digestive Disease Research

    Florham Park, New Jersey, 07932

  • Mid-Atlantic GI Research, LLC

    Greenbelt, Maryland, 20770

  • Gastroenterology Center of Connecticut, PC

    Hamden, Connecticut, 06518

  • Digestive Health Research, LLC

    Hermitage, Tennessee, 37076

  • Homestead Associates In Research Inc

    Homestead, Florida, 33032

  • Birmingham Digestive Health Research, LLC

    Homewood, Alabama, 35209

  • Digestive Health Associates

    Houston, Texas, 77024

  • Grand Teton Research Group

    Idaho Falls, Idaho, 83404

  • Southern Therapy and Advanced Research LLC - Jackson

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Indian Health Service Health Research

    Kissimmee, Florida, 34741

  • Lake Center for Clinical Research

    Lady Lake, Florida, 32159

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    Lake Success, New York, 11042

  • Auzmer Research

    Lakeland, Florida, 33813

  • Emeritas Research Group

    Lansdowne Town Center, Virginia, 20176

  • Interspond - Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Bvl Clinical Research

    Liberty, Missouri, 64068

  • United Medical Doctors

    Los Alamitos, California, 90720

  • Biopharma Informatic Incorporated

    Los Angeles, California, 90035

  • Gastrointestinal Biosciences Clinical Trials Limited Liability Company

    Los Angeles, California, 90067

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Arizona Health Research

    Mesa, Arizona, 85206

  • University of Miami Hospital and Clinic

    Miami, Florida, 33136

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Atlantic Digestive Health Institute

    Morristown, New Jersey, 07960

  • Ocala Gastrointestinal Research, LLC

    Ocala, Florida, 34471

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • University of California Irvine

    Orange, California, 92868

  • AdventHealth Medical Group Gastroenterology and Hepatology

    Orlando, Florida, 32804

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona, 85037

  • North Richmond Health Research

    Richmond, Virginia, 23229

  • GI Select Health Research LLC

    Richmond, Virginia, 23236

  • Hunter Holmes McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • Infigo Clinical Research

    Sanford, Florida, 32771

  • Santa Maria Gastroenterology Medical Group

    Santa Maria, California, 93458

  • Guthrie Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • Premier Health Research LLC

    Sparta, New Jersey, 07871

  • Digestive Specialists Inc Research, LLC

    Springboro, Ohio, 45066

  • Clinical Trials Management Services LLC

    Thousand Oaks, California, 91360

  • Clinical Research Institute of Michigan

    Troy, Michigan, 48098

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • Digestive Research of Central Texas, LLC

    Waco, Texas, 76712

  • Digestive Health Research of North Texas LLC

    Wichita Falls, Texas, 76301

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

Other trials in United States

Japan21 sites

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo, 113-8519

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Hakodate Central General Hospital

    Hakodate-shi, Hokkaido, 040-8585

  • Matsunami General Hospital

    Hashima-gun, Gifu, 501-6062

  • Gokeikai Ofuna Chuo Hospital

    Kamakura-shi, Kanagawa, 247-0056

  • Nara Medical University Hospital

    Kashihara-shi, Nara, 634-8522

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba, 277-0871

  • Kitakyushu Municipal Medical Center

    Kitakyushu-shi, Fukuoka, 802-8561

  • Aoyama Clinic GI Endoscopy and IBD Center

    Kobe, Hyōgo, 650-0015

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, Miyazaki, 880-8510

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Ome Medical Center

    Ome-shi, Tokyo, 198-0042

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Toho University Sakura Medical Center

    Sakura-shi, Chiba, 285-8741

  • Sapporo Tokushukai Hospital

    Sapporo, Hokkaido, 004-0041

  • Takagi Clinic

    Sendai, Miyagi, 981-3213

  • Medical Corporation ENEXT Ikebukuro West Gate Hospital

    Toshima-ku, Tokyo, 171-0021

Other trials in Japan

Turkey (Türkiye)9 sites

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Antalya Egitim ve Arastirma Hastanesi

    Antalya, 07100

  • Uludag Universitesi Tip Fakultesi Hastanesi

    Bursa, 16059

  • Gaziantep Universitesi Tip Fakultesi Hastanesi

    Gaziantep, 27310

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

    Izmir, 35330

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli, 41001

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33343

Other trials in Turkey (Türkiye)

Greece8 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • General Hospital Evangelismos

    Athens, 10676

  • Laiko General Hospital of Athens

    Athens, 11527

  • University Hospital Attikon

    Haidari, 12462

  • Venizeleio General Hospital

    Heraklion, 71409

  • University Hospital of Heraklion

    Heraklion, 71500

  • University General Hospital of Ioannina

    Ioannina, 45500

  • General University Hospital of Patras Panagia i Voithia

    Pátrai, 26504

Other trials in Greece

Italy8 sites

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino IRCCS

    Genoa, 16132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Ospedale Sacro Cuore Don Calabria

    Negrar VR, 37024

  • Ospedale Sandro Pertini

    Roma, 00157

Other trials in Italy

Poland8 sites

  • NZOZ Twoje Zdrowie EL Spzoo

    Elblag, 82-300

  • Centrum Medyczne Med-Gastr Sp zoo

    Lodz, 91-034

  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo

    Malbork, 82-200

  • Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski

    Poznan, 60-123

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60-185

  • BodyClinic spolka z ograniczona odpowiedzialnoscia

    Warsaw, 03-712

  • EuroMediCare Przychodnia Specjalistyczna we Wroclawiu

    Wroclaw, 54-144

  • Centrum Medyczne Melita Medical

    Wroclaw-Krzyki, 50-449

Other trials in Poland

Hungary7 sites

  • Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

    Békéscsaba, 5600

  • MIND Klinika Kft

    Budapest, 1024

  • Clinexpert Kft

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

    Szeged, 6725

  • Clinfan Kft

    Szekszárd, 7100

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

Argentina6 sites

  • Hospital Privado Centro Medico de Cordoba SA

    Córdoba, Córdoba Province, X5000IYH

  • Centro de Investigaciones Medicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600DHK

  • Clinica Independencia

    Munro, Buenos Aires, 1605

  • Cer Instituto Medico

    Quilmes, Buenos Aires, B1878DVB

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, 2000

  • CardioAlem Investigaciones

    San Isidro, Buenos Aires, B1642DSF

Other trials in Argentina

France6 sites

  • Centre Hospitalier Universitaire Amiens Picardie

    Amiens, 80054

  • Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

    Montpellier, 34295

  • Centres Medicaux Chirurgicaux Ambroise Pare Hartmann

    Neuilly-sur-Seine, 92200

  • Centre Hospitalier Universitaire Archet 2

    Nice, 06202

  • Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany6 sites

  • Gastro-Studien GbR Studienzentrum

    Berlin, 10825

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Mexico6 sites

  • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

    Culiacán, Sinaloa, 80230

  • Clinica de Investigacion en Reumatologia y Obesidad SC

    Guadalajra, Jalisco, 44650

  • Clinicos Asociados BOCM SC

    Mexico City, Mexico City, 03300

  • CRI Centro Regiomontano de Investigacion SC

    Monterrey, Nuevo León, 64060

  • Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP

    Monterrey, Nuevo León, 64710

  • Investigacion Biomedica para el Desarrollo de Farmacos SA de CV

    Zapopan, Jalisco, 45070

Other trials in Mexico

Romania6 sites

  • Spitalul Universitar de Urgenta Militar Central Dr Carol Davila

    Bucharest, 010825

  • Clinica Medicum

    Bucharest, 012015

  • Memorial Healthcare International SRL

    Bucharest, 013812

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Pelican

    Oradea, 410445

Other trials in Romania

Czechia5 sites

  • Hepato-Gastroenterologie HK sro

    Hradec Králové, 500 12

  • Nemocnice Pardubickeho kraje as, Pardubicka nemocnice

    Pardubice, 532 03

  • Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze

    Prague, 118 00

  • Axon Clinical sro

    Prague, 150 00

  • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz

    Ústí nad Labem, 401 13

Other trials in Czechia

South Korea5 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Yeungnam University Medical Center

    Daegu, 42415

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Wonju Severance Christian Hospital

    Wonju-si, Gangwon-do, 26426

Other trials in South Korea

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Herlev Hospital

    Herlev, 2730

  • Hvidovre Hospital

    Hvidovre, 2650

  • Bispebjerg Hospital

    København NV, 2400

Other trials in Denmark

Spain4 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28028

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Switzerland4 sites

  • Inselspital Bern

    Bern, 3010

  • Intesto BE

    Bern, 3012

  • Kantonsspital St Gallen

    Sankt Gallen, 9007

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Austria3 sites

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

Other trials in Belgium

Bulgaria3 sites

  • Second Multiprofile Hospital for Active Treatment - Sofia EAD

    Sofia, 1202

  • Diagnostic-Consultative Center Convex EOOD

    Sofia, 1680

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD

    Sofia, 1784

Other trials in Bulgaria

Canada3 sites

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6K 4B2

  • London Health Sciences Centre, University Hospital

    London, Ontario, N6A 5A5

  • TIDHI Innovation Incorporated

    Toronto, Ontario, M6A 3B4

Other trials in Canada

Netherlands3 sites

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Elisabeth TweeSteden Ziekenhuis

    Tilburg, 5022 GC

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Slovakia3 sites

  • Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Endomed, sro

    Košice, 040 13

  • Gastro I, sro

    Prešov, 080 01

Other trials in Slovakia

Taiwan3 sites

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Latvia2 sites

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Gastro Centrs

    Riga, 1079

Other trials in Latvia

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00290

Other trials in Finland

About this study

Official title: A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.

Being tested
Efavaleukin alfa, Placebo
Keywords
Ulcerative Colitis, UC, Efavaleukin Alfa
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Efavaleukin alfaDrug

    Also called AMG 592

    Efavaleukin alfa will be administered by subcutaneous (SC) injection.

  • PlaceboDrug

    Placebo will be administered by SC injection.

Study groups in NCT04987307
Study groupRoleWhat they receive
Arm A: Efavaleukin alfaExperimentalEfavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)
Receives: Drug: Efavaleukin alfa
Arm B: Efavaleukin alfaExperimentalEfavaleukin alfa Dose 2 administered by SC injection Q2W
Receives: Drug: Efavaleukin alfa
Arm C: Efavaleukin alfaExperimentalEfavaleukin alfa Dose 3 administered by SC injection Q2W
Receives: Drug: Efavaleukin alfa
Arm D: PlaceboPlacebo comparatorPlacebo Q2W
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Clinical Remission at Week 12

    Clinical remission was defined as a modified Mayo score of 0 to 2, including a rectal bleeding subscore of 0, a stool frequency subscore of 0 or 1, and a centrally read endoscopy subscore of 0 or 1 (modified so that 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

    Measured: Week 12

Secondary outcomes (6)

  1. Percentage of Participants With Clinical Response at Week 12

    Clinical response was defined as a decrease from baseline in the modified Mayo score of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding subscore of 0 or 1. The modified Mayo score was the total Mayo score without the physician's global assessment subscore and ranged from 0 to 9 points, with higher scores indicating more severe disease. Only participants who had the opportunity to complete the visit by the date of the decision for the study termination were included in this outcome measure. Efficacy data collected after this date were censored and excluded from analyses.

    Measured: Baseline and Week 12

  2. Percentage of Participants With Endoscopic Remission at Week 12

    Endoscopic remission was defined as a Mayo centrally read endoscopy subscore of 0 or 1 (modified so that a score of 1 did not include friability). The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

    Measured: Week 12

  3. Percentage of Participants With Symptomatic Remission at Week 12

    Symptomatic remission was defined as Mayo stool frequency subscore of 0 or 1 and rectal bleeding subscore of 0. The modified Mayo score was the total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

    Measured: Week 12

  4. Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12

    Combined endoscopic and histologic remission was defined as combined endoscopic remission (Mayo centrally read endoscopy subscore of 0 or 1) and histologic remission of the colon tissue (Geboes Score < 2.0; no neutrophils in epithelium crypts or lamina propria and no increase in eosinophils, no crypt destruction and no erosions, ulcerations or granulation tissue). Geobes score was defined as: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated degree of abnormality, with subscores of 0 indicating normal appearance and higher subscores indicating increasingly abnormal appearance. The modified Mayo score was total Mayo score ranged from 0 to 9 points, with higher scores indicating more severe disease.

    Measured: Week 12

  5. Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score

    The Geboes score was an instrument used to standardize histologic assessment in ulcerative colitis (UC). It comprised seven categories (or grades), each describing a histologic feature. These categories were as follows: grade 0, structural (architectural change); grade 1, chronic inflammatory infiltrate; grade 2A, lamina propria eosinophils; grade 2B, lamina propria neutrophils; grade 3, neutrophils in epithelium; grade 4, crypt destruction; and grade 5, erosion or ulceration. Each grade included subscores that indicated the degree of abnormality observed for that histologic feature. Subscores ranged from 0 to 5.4, where a score of 0 indicated no or minimal inflammation, and a maximum score of 5.4 reflected severe histological activity.

    Measured: Baseline to Week 12

  6. Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

    TEAEs were events categorized as adverse events (AEs) that started on or after the first dose of investigational product (IP), and up to 12 weeks in induction period.

    Measured: Up to 12 weeks

Timeline

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

  1. First posted3 Aug 2021
  2. Study start31 Jan 2022
  3. Primary completion22 Oct 2024
  4. Study completion22 Oct 2024

Why it stopped: The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.

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
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04987307
Sponsor's protocol ID
20170104
Other IDs
2021-002537-41
Status last verified
Dec 2025
First submitted
26 Jul 2021
Last updated
13 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efavaleukin alfa in people with Ulcerative Colitis, run by Amgen at 200 sites in 26 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 24 inclusion and 13 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 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 200 sites in United States, Japan, Turkey (Türkiye), Greece, Italy and 21 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 13 Jan 2026). 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?

Percentage of Participants With Clinical Remission at Week 12 (time frame: 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 NCT04987307.

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 13 Jan 2026.

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