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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: Efavaleukin alfa

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, B7600DHK
      • Centro de Investigaciones Medicas Mar Del Plata
    • Munro, Buenos Aires, Argentina, 1605
      • Clinica Independencia
    • Quilmes, Buenos Aires, Argentina, B1878DVB
      • CER Instituto Medico
    • San Isidro, Buenos Aires, Argentina, B1642DSF
      • CardioAlem Investigaciones
  • Córdoba Province
    • Córdoba, Córdoba Province, Argentina, X5000IYH
      • Hospital Privado Centro Medico de Cordoba SA
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Fundacion Estudios Clinicos
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitaet Innsbruck
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
  • Vienna, Austria, 1090
    • Universitaetsklinikum Allgemeines Krankenhaus Wien
• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
• Bulgaria
  • Sofia, Bulgaria, 1680
    • Diagnostic-Consultative Center Convex EOOD
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment - Sofia EAD
  • Sofia, Bulgaria, 1784
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6K 4B2
      • South Edmonton Gastroenterology
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital
    • Toronto, Ontario, Canada, M6A 3B4
      • TIDHI Innovation Incorporated
• Czechia
  • Hradec Králové, Czechia, 500 12
    • Hepato-Gastroenterologie HK sro
  • Pardubice, Czechia, 532 03
    • Nemocnice Pardubickeho kraje as, Pardubicka nemocnice
  • Prague, Czechia, 118 00
    • Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze
  • Prague, Czechia, 150 00
    • Axon Clinical sro
  • Ústí nad Labem, Czechia, 401 13
    • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Herlev, Denmark, 2730
    • Herlev Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • København NV, Denmark, 2400
    • Bispebjerg Hospital
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital
• France
  • Amiens, France, 80054
    • Centre Hospitalier Universitaire Amiens Picardie
  • Montpellier, France, 34295
    • Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
  • Neuilly-sur-Seine, France, 92200
    • Centres Medicaux Chirurgicaux Ambroise Pare Hartmann
  • Nice, France, 06202
    • Centre Hospitalier Universitaire Archet 2
  • Saint-Priest-en-Jarez, France, 42270
    • Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
• Germany
  • Berlin, Germany, 10825
    • Gastro-Studien GbR Studienzentrum
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
• Greece
  • Alexandroupoli, Greece, 68100
    • University General Hospital of Alexandroupolis
  • Athens, Greece, 10676
    • General Hospital Evangelismos
  • Athens, Greece, 11527
    • Laiko General Hospital of Athens
  • Haidari, Greece, 12462
    • University Hospital Attikon
  • Heraklion, Greece, 71500
    • University Hospital of Heraklion
  • Heraklion, Greece, 71409
    • Venizeleio General Hospital
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina
  • Pátrai, Greece, 26504
    • General University Hospital of Patras Panagia i Voithia
• Hungary
  • Budapest, Hungary, 1036
    • Obudai Egeszsegugyi Centrum Kft
  • Budapest, Hungary, 1033
    • Clinexpert Kft
  • Budapest, Hungary, 1024
    • MIND Klinika Kft
  • Békéscsaba, Hungary, 5600
    • Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
  • Szekszárd, Hungary, 7100
    • Clinfan Kft
  • Tatabánya, Hungary, 2800
    • Komárom-Esztergom Vármegyei Szent Borbála Kórház
• Italy
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliera Universitaria Renato Dulbecco
  • Florence, Italy, 50134
    • Azienda Ospedaliero Universitaria Careggi
  • Genoa, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • Milan, Italy, 20122
    • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Milan, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Negrar VR, Italy, 37024
    • Ospedale Sacro Cuore Don Calabria
  • Roma, Italy, 00157
    • Ospedale Sandro Pertini
• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Tsujinaka Hospital Kashiwanoha
    • Sakura-shi, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 802-8561
      • Kitakyushu Municipal Medical Center
  • Gifu
    • Gifu, Gifu, Japan, 501-1194
      • Gifu University Hospital
    • Hashima-gun, Gifu, Japan, 501-6062
      • Matsunami General Hospital
  • Hokkaido
    • Hakodate-shi, Hokkaido, Japan, 040-8585
      • Hakodate Central General Hospital
    • Sapporo, Hokkaido, Japan, 004-0041
      • Sapporo Tokushukai Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0015
      • Aoyama Clinic GI Endoscopy and IBD Center
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Gokeikai Ofuna Chuo Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 981-3213
      • Takagi Clinic
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-8510
      • Miyazaki Prefectural Miyazaki Hospital
  • Nagasaki
    • Nagasaki, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital
  • Nara
    • Kashihara-shi, Nara, Japan, 634-8522
      • Nara Medical University Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 701-1192
      • National Hospital Organization Okayama Medical Center
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Osaka Metropolitan university Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital
    • Ome-shi, Tokyo, Japan, 198-0042
      • Ome Medical Center
    • Toshima-ku, Tokyo, Japan, 171-0021
      • Medical Corporation ENEXT Ikebukuro West Gate Hospital
  • Yamanashi
    • Kofu, Yamanashi, Japan, 400-8506
      • Yamanashi Prefectural Central Hospital
• Latvia
  • Riga, Latvia, 1002
    • Pauls Stradinš Clinical University Hospital
  • Riga, Latvia, 1079
    • Gastro Centrs
• Mexico
  • Jalisco
    • Guadalajra, Jalisco, Mexico, 44650
      • Clinica de Investigacion en Reumatologia y Obesidad SC
    • Zapopan, Jalisco, Mexico, 45070
      • Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03300
      • Clinicos Asociados BOCM SC
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64060
      • CRI Centro Regiomontano de Investigacion SC
    • Monterrey, Nuevo León, Mexico, 64710
      • Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80230
      • Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth Tweesteden Ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Elblag, Poland, 82-300
    • NZOZ Twoje Zdrowie EL Spzoo
  • Lodz, Poland, 91-034
    • Centrum Medyczne Med-Gastr Sp zoo
  • Malbork, Poland, 82-200
    • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
  • Poznan, Poland, 60-123
    • Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski
  • Skorzewo, Poland, 60-185
    • Centrum Medyczne Pratia Poznan
  • Warsaw, Poland, 03-712
    • BodyClinic spolka z ograniczona odpowiedzialnoscia
  • Wroclaw, Poland, 54-144
    • EuroMediCare Przychodnia Specjalistyczna we Wroclawiu
  • Wroclaw-Krzyki, Poland, 50-449
    • Centrum Medyczne Melita Medical
• Romania
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucharest, Romania, 012015
    • Clinica Medicum
  • Bucharest, Romania, 013812
    • Memorial Healthcare International SRL
  • Bucharest, Romania, 010825
    • Spitalul Universitar de Urgenta Militar Central Dr Carol Davila
  • Oradea, Romania, 410445
    • Spitalul Clinic Pelican
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
  • Košice, Slovakia, 040 13
    • Endomed, sro
  • Prešov, Slovakia, 080 01
    • Gastro I, sro
• South Korea
  • Busan, South Korea, 48108
    • Inje university Haeundae Paik Hospital
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 06591
    • The Catholic University of Korea Seoul St Marys Hospital
  • Wonju-si, Gangwon-do, South Korea, 26426
    • Wonju Severance Christian Hospital
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28028
    • Hospital General Universitario Gregorio Marañón
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Bern, Switzerland, 3012
    • Intesto BE
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital St Gallen
  • Zurich, Switzerland, 8091
    • Universitaetsspital Zuerich
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi
  • Antalya, Turkey (Türkiye), 07100
    • Antalya Egitim ve Arastirma Hastanesi
  • Bursa, Turkey (Türkiye), 16059
    • Uludag Universitesi Tip Fakultesi Hastanesi
  • Gaziantep, Turkey (Türkiye), 27310
    • Gaziantep Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey (Türkiye), 35330
    • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
  • Kocaeli, Turkey (Türkiye), 41001
    • Kocaeli Universitesi Tip Fakultesi Hastanesi
  • Mersin, Turkey (Türkiye), 33343
    • Mersin Universitesi Tip Fakultesi Hastanesi
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists Of The Southeast
    • Homewood, Alabama, United States, 35209
      • Birmingham Digestive Health Research, LLC
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Arizona Health Research
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis and Rheumatology Research, PLLC
  • California
    • Coronado, California, United States, 92118
      • Southern California Research Center
    • Los Alamitos, California, United States, 90720
      • United Medical Doctors
    • Los Angeles, California, United States, 90035
      • Biopharma Informatic Incorporated
    • Los Angeles, California, United States, 90067
      • Gastrointestinal Biosciences Clinical Trials Limited Liability Company
    • Orange, California, United States, 92868
      • University of California Irvine
    • Santa Maria, California, United States, 93458
      • Santa Maria Gastroenterology Medical Group
    • Thousand Oaks, California, United States, 91360
      • Clinical Trials Management Services LLC
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut, PC
  • Florida
    • Clearwater, Florida, United States, 33756
      • West Central Gastroenterology
    • Homestead, Florida, United States, 33032
      • Homestead Associates in Research Inc
    • Kissimmee, Florida, United States, 34741
      • Indian Health Service Health Research
    • Lady Lake, Florida, United States, 32159
      • Lake Center for Clinical Research
    • Lakeland, Florida, United States, 33813
      • Auzmer Research
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinic
    • Ocala, Florida, United States, 34471
      • Ocala Gastrointestinal Research, LLC
    • Orlando, Florida, United States, 32804
      • AdventHealth Medical Group Gastroenterology and Hepatology
    • Sanford, Florida, United States, 32771
      • Infigo Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Columbus, Georgia, United States, 31901
      • Columbus Regional Research Institute, LLC
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Grand Teton Research Group
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • South Bend, Indiana, United States, 46635
      • Digestive Research Alliance of Michiana
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Greenbelt, Maryland, United States, 20770
      • Mid-Atlantic GI Research, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School - Brigham and Womens Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Troy, Michigan, United States, 48098
      • Clinical Research Institute of Michigan
    • Wyoming, Michigan, United States, 49519
      • West Michigan Clinical Research Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Southern Therapy and Advanced Research LLC - Jackson
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Gastrointestinal Associates Research, LLC
    • Liberty, Missouri, United States, 64068
      • BVL Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Interspond - Las Vegas Medical Research
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • Sanmora Bespoke Clinical Research Solutions
    • Egg Harbor, New Jersey, United States, 08234
      • Aga Clinical Research Associates LLC
    • Florham Park, New Jersey, United States, 07932
      • Affiliates in Gastroenterology Digestive Disease Research
    • Morristown, New Jersey, United States, 07960
      • Atlantic Digestive Health Institute
    • Sparta, New Jersey, United States, 07871
      • Premier Health Research LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico
  • New York
    • Lake Success, New York, United States, 11042
      • New York University Grossman School of Medicine and New York University Langone Hospitals
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Springboro, Ohio, United States, 45066
      • Digestive Specialists Inc Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Robert Packer Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29204
      • Columbia Digestive Health Research LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Wake Research-ClinSearch, LLC
    • Hermitage, Tennessee, United States, 37076
      • Digestive Health Research, LLC
  • Texas
    • El Paso, Texas, United States, 79912
      • Great Lakes Research Insititute El Paso Research
    • Houston, Texas, United States, 77024
      • Digestive Health Associates
    • Waco, Texas, United States, 76712
      • Digestive Research of Central Texas, LLC
    • Wichita Falls, Texas, United States, 76301
      • Digestive Health Research of North Texas LLC
  • Virginia
    • Lansdowne Town Center, Virginia, United States, 20176
      • Emeritas Research Group
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire Veterans Affairs Medical Center
    • Richmond, Virginia, United States, 23229
      • North Richmond Health Research
    • Richmond, Virginia, United States, 23236
      • GI Select Health Research LLC
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.
  • 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:

  1. 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.

  2. 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.

Key Exclusion Criteria:

• 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.
  • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Efavaleukin alfa; Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)	Drug: Efavaleukin alfa; Efavaleukin alfa will be administered by subcutaneous (SC) injection.; Other Names: AMG 592
Experimental: Arm B: Efavaleukin alfa; Efavaleukin alfa Dose 2 administered by SC injection Q2W	Drug: Efavaleukin alfa; Efavaleukin alfa will be administered by subcutaneous (SC) injection.; Other Names: AMG 592
Experimental: Arm C: Efavaleukin alfa; Efavaleukin alfa Dose 3 administered by SC injection Q2W	Drug: Efavaleukin alfa; Efavaleukin alfa will be administered by subcutaneous (SC) injection.; Other Names: AMG 592
Placebo Comparator: Arm D: Placebo; Placebo Q2W	Drug: Placebo; Placebo will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 12
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.	Week 12
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.	Week 12
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.	Week 12
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.	Baseline to Week 12
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.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; UC; Efavaleukin Alfa
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 20170104; 2021-002537-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No