Study Stopped
The study was terminated due to meeting a prespecified futility rule and not related to any safety concerns.
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
2 other identifiers
interventional
221
26 countries
200
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
200 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2024
CompletedResults Posted
Study results publicly available
January 13, 2026
CompletedJanuary 13, 2026
December 1, 2025
2.7 years
July 26, 2021
October 13, 2025
December 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 12
Secondary Outcomes (6)
Percentage of Participants With Clinical Response at Week 12
Baseline and Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Week 12
Percentage of Participants With Symptomatic Remission at Week 12
Week 12
Percentage of Participants With Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
Week 12
Change From Baseline in Histological Score at Week 12 as Measured by the Geboes Score
Baseline to Week 12
- +1 more secondary outcomes
Study Arms (4)
Arm A: Efavaleukin alfa
EXPERIMENTALEfavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)
Arm B: Efavaleukin alfa
EXPERIMENTALEfavaleukin alfa Dose 2 administered by SC injection Q2W
Arm C: Efavaleukin alfa
EXPERIMENTALEfavaleukin alfa Dose 3 administered by SC injection Q2W
Arm D: Placebo
PLACEBO COMPARATORPlacebo Q2W
Interventions
Efavaleukin alfa will be administered by subcutaneous (SC) injection.
Eligibility Criteria
You may qualify if:
- 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:
- 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:
- +9 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (200)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Birmingham Digestive Health Research, LLC
Homewood, Alabama, 35209, United States
Arizona Health Research
Mesa, Arizona, 85206, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85037, United States
Southern California Research Center
Coronado, California, 92118, United States
United Medical Doctors
Los Alamitos, California, 90720, United States
Biopharma Informatic Incorporated
Los Angeles, California, 90035, United States
Gastrointestinal Biosciences Clinical Trials Limited Liability Company
Los Angeles, California, 90067, United States
University of California Irvine
Orange, California, 92868, United States
Santa Maria Gastroenterology Medical Group
Santa Maria, California, 93458, United States
Clinical Trials Management Services LLC
Thousand Oaks, California, 91360, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, 06518, United States
West Central Gastroenterology
Clearwater, Florida, 33756, United States
Homestead Associates In Research Inc
Homestead, Florida, 33032, United States
Indian Health Service Health Research
Kissimmee, Florida, 34741, United States
Lake Center for Clinical Research
Lady Lake, Florida, 32159, United States
Auzmer Research
Lakeland, Florida, 33813, United States
University of Miami Hospital and Clinic
Miami, Florida, 33136, United States
Ocala Gastrointestinal Research, LLC
Ocala, Florida, 34471, United States
AdventHealth Medical Group Gastroenterology and Hepatology
Orlando, Florida, 32804, United States
Infigo Clinical Research
Sanford, Florida, 32771, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Columbus Regional Research Institute, LLC
Columbus, Georgia, 31901, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, 46635, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland, 20770, United States
Harvard Medical School - Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan
Troy, Michigan, 48098, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
Southern Therapy and Advanced Research LLC - Jackson
Jackson, Mississippi, 39216, United States
Gastrointestinal Associates Research, LLC
Columbia, Missouri, 65201, United States
Bvl Clinical Research
Liberty, Missouri, 64068, United States
Interspond - Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Sanmora Bespoke Clinical Research Solutions
East Orange, New Jersey, 07018, United States
Aga Clinical Research Associates LLC
Egg Harbor, New Jersey, 08234, United States
Affiliates in Gastroenterology Digestive Disease Research
Florham Park, New Jersey, 07932, United States
Atlantic Digestive Health Institute
Morristown, New Jersey, 07960, United States
Premier Health Research LLC
Sparta, New Jersey, 07871, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
Lake Success, New York, 11042, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Digestive Specialists Inc Research, LLC
Springboro, Ohio, 45066, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Columbia Digestive Health Research LLC
Columbia, South Carolina, 29204, United States
Wake Research-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Digestive Health Research, LLC
Hermitage, Tennessee, 37076, United States
Great Lakes Research Insititute El Paso Research
El Paso, Texas, 79912, United States
Digestive Health Associates
Houston, Texas, 77024, United States
Digestive Research of Central Texas, LLC
Waco, Texas, 76712, United States
Digestive Health Research of North Texas LLC
Wichita Falls, Texas, 76301, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
North Richmond Health Research
Richmond, Virginia, 23229, United States
GI Select Health Research LLC
Richmond, Virginia, 23236, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, B7600DHK, Argentina
Clinica Independencia
Munro, Buenos Aires, 1605, Argentina
Cer Instituto Medico
Quilmes, Buenos Aires, B1878DVB, Argentina
CardioAlem Investigaciones
San Isidro, Buenos Aires, B1642DSF, Argentina
Hospital Privado Centro Medico de Cordoba SA
Córdoba, Córdoba Province, X5000IYH, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, 2000, Argentina
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Second Multiprofile Hospital for Active Treatment - Sofia EAD
Sofia, 1202, Bulgaria
Diagnostic-Consultative Center Convex EOOD
Sofia, 1680, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD
Sofia, 1784, Bulgaria
South Edmonton Gastroenterology
Edmonton, Alberta, T6K 4B2, Canada
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5, Canada
TIDHI Innovation Incorporated
Toronto, Ontario, M6A 3B4, Canada
Hepato-Gastroenterologie HK sro
Hradec Králové, 500 12, Czechia
Nemocnice Pardubickeho kraje as, Pardubicka nemocnice
Pardubice, 532 03, Czechia
Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze
Prague, 118 00, Czechia
Axon Clinical sro
Prague, 150 00, Czechia
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
Ústí nad Labem, 401 13, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Bispebjerg Hospital
København NV, 2400, Denmark
Helsinki University Central Hospital
Helsinki, 00290, Finland
Centre Hospitalier Universitaire Amiens Picardie
Amiens, 80054, France
Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi
Montpellier, 34295, France
Centres Medicaux Chirurgicaux Ambroise Pare Hartmann
Neuilly-sur-Seine, 92200, France
Centre Hospitalier Universitaire Archet 2
Nice, 06202, France
Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270, France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Gastro-Studien GbR Studienzentrum
Berlin, 10825, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Frankfurt
Frankfurt am Main, 60590, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
General Hospital Evangelismos
Athens, 10676, Greece
Laiko General Hospital of Athens
Athens, 11527, Greece
University Hospital Attikon
Haidari, 12462, Greece
Venizeleio General Hospital
Heraklion, 71409, Greece
University Hospital of Heraklion
Heraklion, 71500, Greece
University General Hospital of Ioannina
Ioannina, 45500, Greece
General University Hospital of Patras Panagia i Voithia
Pátrai, 26504, Greece
Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
MIND Klinika Kft
Budapest, 1024, Hungary
Clinexpert Kft
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6725, Hungary
Clinfan Kft
Szekszárd, 7100, Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Ospedale Policlinico San Martino IRCCS
Genoa, 16132, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Sacro Cuore Don Calabria
Negrar VR, 37024, Italy
Ospedale Sandro Pertini
Roma, 00157, Italy
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Chiba, 277-0871, Japan
Toho University Sakura Medical Center
Sakura-shi, Chiba, 285-8741, Japan
Kitakyushu Municipal Medical Center
Kitakyushu-shi, Fukuoka, 802-8561, Japan
Gifu University Hospital
Gifu, Gifu, 501-1194, Japan
Matsunami General Hospital
Hashima-gun, Gifu, 501-6062, Japan
Hakodate Central General Hospital
Hakodate-shi, Hokkaido, 040-8585, Japan
Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041, Japan
Aoyama Clinic GI Endoscopy and IBD Center
Kobe, Hyōgo, 650-0015, Japan
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056, Japan
Takagi Clinic
Sendai, Miyagi, 981-3213, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Miyazaki, 880-8510, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611, Japan
Ome Medical Center
Ome-shi, Tokyo, 198-0042, Japan
Medical Corporation ENEXT Ikebukuro West Gate Hospital
Toshima-ku, Tokyo, 171-0021, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Gastro Centrs
Riga, 1079, Latvia
Clinica de Investigacion en Reumatologia y Obesidad SC
Guadalajra, Jalisco, 44650, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan, Jalisco, 45070, Mexico
Clinicos Asociados BOCM SC
Mexico City, Mexico City, 03300, Mexico
CRI Centro Regiomontano de Investigacion SC
Monterrey, Nuevo León, 64060, Mexico
Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP
Monterrey, Nuevo León, 64710, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC
Culiacán, Sinaloa, 80230, Mexico
Leids Universitair Medisch Centrum
Leiden, 2333 ZA, Netherlands
Elisabeth TweeSteden Ziekenhuis
Tilburg, 5022 GC, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
NZOZ Twoje Zdrowie EL Spzoo
Elblag, 82-300, Poland
Centrum Medyczne Med-Gastr Sp zoo
Lodz, 91-034, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
Malbork, 82-200, Poland
Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski
Poznan, 60-123, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185, Poland
BodyClinic spolka z ograniczona odpowiedzialnoscia
Warsaw, 03-712, Poland
EuroMediCare Przychodnia Specjalistyczna we Wroclawiu
Wroclaw, 54-144, Poland
Centrum Medyczne Melita Medical
Wroclaw-Krzyki, 50-449, Poland
Spitalul Universitar de Urgenta Militar Central Dr Carol Davila
Bucharest, 010825, Romania
Clinica Medicum
Bucharest, 012015, Romania
Memorial Healthcare International SRL
Bucharest, 013812, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Clinic Pelican
Oradea, 410445, Romania
Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Endomed, sro
Košice, 040 13, Slovakia
Gastro I, sro
Prešov, 080 01, Slovakia
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, 26426, South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28028, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Inselspital Bern
Bern, 3010, Switzerland
Intesto BE
Bern, 3012, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9007, Switzerland
Universitaetsspital Zuerich
Zurich, 8091, Switzerland
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Uludag Universitesi Tip Fakultesi Hastanesi
Bursa, 16059, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, 35330, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41001, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33343, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to meeting a predefined futility criterion and not related to any safety concerns.
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 3, 2021
Study Start
January 31, 2022
Primary Completion
October 22, 2024
Study Completion
October 22, 2024
Last Updated
January 13, 2026
Results First Posted
January 13, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.