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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987307
• Other study ID #: 20170104
• Secondary ID: 2021-002537-41
• Status: Recruiting
• Phase: Phase 2
• Start date: January 31, 2022
• Est. completion date: December 26, 2025

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 26, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Efavaleukin alfa
Efavaleukin alfa will be administered by subcutaneous (SC) injection.
• Placebo
Placebo will be administered by SC injection.

Locations

Country	Name	City	State
Argentina	Hospital Privado Centro Medico de Cordoba SA	Cordoba	Córdoba
Argentina	Centro de Investigaciones Medicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Clinica Independencia	Munro	Buenos Aires
Argentina	Cer Instituto Medico	Quilmes	Buenos Aires
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Argentina	CardioAlem Investigaciones	San Isidro	Buenos Aires
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Landeskrankenhaus Salzburg	Salzburg
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire de Liege - Sart Tilman	Liège
Bulgaria	Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD	Sofia
Bulgaria	Diagnostic-Consultative Center Convex EOOD	Sofia
Bulgaria	Second Multiprofile Hospital for Active Treatment - Sofia EAD	Sofia
Canada	South Edmonton Gastroenterology	Edmonton	Alberta
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	TIDHI Innovation Incorporated	Toronto	Ontario
Czechia	Hepato-Gastroenterologie HK sro	Hradec Kralove
Czechia	Nemocnice Pardubickeho kraje as, Pardubicka nemocnice	Pardubice
Czechia	Axon Clinical sro	Praha
Czechia	Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze	Praha
Czechia	Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz	Usti nad Labem
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Herlev Hospital	Herlev
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Bispebjerg Hospital	Kobenhavn NV
Finland	Helsinki University Central Hospital	Helsinki
France	Centre Hospitalier Universitaire Amiens Picardie	Amiens cedex 1
France	Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi	Montpellier cedex 5
France	Centres Medicaux Chirurgicaux Ambroise Pare Hartmann	Neuilly sur seine
France	Centre Hospitalier Universitaire Archet 2	Nice cedex 3
France	Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord	Saint Priest en Jarez
France	Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois	Vandoeuvre les Nancy Cedex
Germany	Gastro-Studien GbR Studienzentrum	Berlin
Germany	Universitaetsklinikum Essen	Essen
Germany	Universitaetsklinikum Frankfurt	Frankfurt am Main
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Universitaetsklinikum Tuebingen	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Greece	University General Hospital of Alexandroupolis	Alexandroupoli
Greece	General Hospital Evangelismos	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	University Hospital Attikon	Haidari
Greece	University Hospital of Heraklion	Heraklion
Greece	Venizeleio General Hospital	Heraklion
Greece	University General Hospital of Ioannina	Ioannina
Greece	General University Hospital of Patras Panagia i Voithia	Patras
Hungary	Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz	Bekescsaba
Hungary	Clinexpert Kft	Budapest
Hungary	MIND Klinika Kft	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft	Budapest
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar	Szeged
Hungary	Clinfan Kft	Szekszard
Hungary	Komarom-Esztergom Varmegyei Szent Borbala Korhaz	Tatabanya
Italy	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera Universitaria Renato Dulbecco	Catanzaro
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Ospedale Policlinico San Martino IRCCS	Genoa
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Ospedale Sacro Cuore Don Calabria	Negrar VR
Italy	Ospedale Sandro Pertini	Roma
Japan	Tokyo Medical and Dental University Hospital	Bunkyo-ku	Tokyo
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Hakodate Central General Hospital	Hakodate-shi	Hokkaido
Japan	Matsunami General Hospital	Hashima-gun	Gifu
Japan	Gokeikai Ofuna Chuo Hospital	Kamakura-shi	Kanagawa
Japan	Nara Medical University Hospital	Kashihara-shi	Nara
Japan	Tsujinaka Hospital Kashiwanoha	Kashiwa-shi	Chiba
Japan	Kitakyushu Municipal Medical Center	Kitakyushu-shi	Fukuoka
Japan	Aoyama Clinic GI Endoscopy and IBD Center	Kobe-shi	Hyogo
Japan	Yamanashi Prefectural Central Hospital	Kofu-shi	Yamanashi
Japan	Kitasato University Kitasato Institute Hospital	Minato-ku	Tokyo
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Miyazaki Prefectural Miyazaki Hospital	Miyazaki-shi	Miyazaki
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	National Hospital Organization Okayama Medical Center	Okayama-shi	Okayama
Japan	Ome Medical Center	Ome-shi	Tokyo
Japan	Osaka Metropolitan University Hospital	Osaka-shi	Osaka
Japan	Toho University Sakura Medical Center	Sakura-shi	Chiba
Japan	Sapporo Tokushukai Hospital	Sapporo-shi	Hokkaido
Japan	Takagi Clinic	Sendai-shi	Miyagi
Japan	Medical Corporation ENEXT Ikebukuro West Gate Hospital	Toshima-ku	Tokyo
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St Marys Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju-si, Gangwon-do
Latvia	Gastro Centrs	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Mexico	Clinicos Asociados BOCM SC	Ciudad de Mexico	Distrito Federal
Mexico	Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC	Culiacan	Sinaloa
Mexico	Clinica de Investigacion en Reumatologia y Obesidad SC	Guadalajra	Jalisco
Mexico	CRI Centro Regiomontano de Investigacion SC	Monterrey	Nuevo León
Mexico	Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP	Monterrey	Nuevo León
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos SA de CV	Zapopan	Jalisco
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Elisabeth TweeSteden Ziekenhuis	Tilburg
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	NZOZ Twoje Zdrowie EL Spzoo	Elblag
Poland	Centrum Medyczne Med-Gastr Sp zoo	Lodz
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo	Malbork
Poland	Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski	Poznan
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	BodyClinic spolka z ograniczona odpowiedzialnoscia	Warszawa
Poland	EuroMediCare Przychodnia Specjalistyczna we Wroclawiu	Wroclaw
Poland	Centrum Medyczne Melita Medical	Wroclaw-Krzyki
Romania	Institutul Clinic Fundeni	Bucharest
Romania	Clinica Medicum	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul de Oncologie Monza SRL	Bucuresti
Romania	Spitalul Universitar de Urgenta Militar Central Dr Carol Davila	Bucuresti
Romania	Spitalul Clinic Pelican	Oradea
Slovakia	Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica	Banska Bystrica
Slovakia	Endomed, sro	Kosice
Slovakia	Gastro I, sro	Presov
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluña
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz	Madrid
Switzerland	Inselspital Bern	Bern
Switzerland	Intesto BE	Bern
Switzerland	Kantonsspital St Gallen	Sankt Gallen
Switzerland	Universitaetsspital Zuerich	Zurich
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Turkey	Antalya Egitim ve Arastirma Hastanesi	Antalya
Turkey	Uludag Universitesi Tip Fakultesi Hastanesi	Bursa
Turkey	Gaziantep Universitesi Tip Fakultesi Hastanesi	Gaziantep
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul
Turkey	Dokuz Eylul Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi	Mersin
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Harvard Medical School - Brigham and Womens Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Wake Research-ClinSearch, LLC	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	West Central Gastroenterology	Clearwater	Florida
United States	Columbia Digestive Health Research LLC	Columbia	South Carolina
United States	Gastrointestinal Associates Research, LLC	Columbia	Missouri
United States	Columbus Regional Research Institute, LLC	Columbus	Georgia
United States	Southern California Research Center	Coronado	California
United States	Digestive Health Specialists of the Southeast	Dothan	Alabama
United States	Sanmora Bespoke Clinical Research Solutions	East Orange	New Jersey
United States	Aga Clinical Research Associates LLC	Egg Harbor Township	New Jersey
United States	Great Lakes Research Insititute El Paso Research	El Paso	Texas
United States	Affiliates in Gastroenterology Digestive Disease Research	Florham Park	New Jersey
United States	Mid-Atlantic GI Research, LLC	Greenbelt	Maryland
United States	Gastroenterology Center of Connecticut, PC	Hamden	Connecticut
United States	Digestive Health Research, LLC	Hermitage	Tennessee
United States	Homestead Associates In Research Inc	Homestead	Florida
United States	Birmingham Digestive Health Research, LLC	Homewood	Alabama
United States	Digestive Health Associates	Houston	Texas
United States	Grand Teton Research Group	Idaho Falls	Idaho
United States	Southern Therapy and Advanced Research LLC - Jackson	Jackson	Mississippi
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Indian Health Service Health Research	Kissimmee	Florida
United States	Lake Center for Clinical Research	Lady Lake	Florida
United States	New York University Langone Medical Center	Lake Success	New York
United States	Auzmer Research	Lakeland	Florida
United States	Emeritas Research Group	Lansdowne Town Center	Virginia
United States	Interspond - Las Vegas Medical Research	Las Vegas	Nevada
United States	bvl Clinical Research	Liberty	Missouri
United States	United Medical Doctors	Los Alamitos	California
United States	Biopharma Informatic Inc	Los Angeles	California
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	Arizona Health Research	Mesa	Arizona
United States	University of Miami Hospital and Clinic	Miami	Florida
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Atlantic Digestive Health Institute	Morristown	New Jersey
United States	Ocala Gastrointestinal Research, LLC	Ocala	Florida
United States	Hightower Clinical	Oklahoma City	Oklahoma
United States	University of California Irvine	Orange	California
United States	AdventHealth Medical Group Gastroenterology and Hepatology	Orlando	Florida
United States	Arizona Arthritis and Rheumatology Research, PLLC	Phoenix	Arizona
United States	GI Select Health Research LLC	Richmond	Virginia
United States	Hunter Holmes McGuire Veterans Medical Center	Richmond	Virginia
United States	North Richmond Health Research	Richmond	Virginia
United States	Infigo Clinical Research	Sanford	Florida
United States	Santa Maria Gastroenterology Medical Group	Santa Maria	California
United States	Guthrie Robert Packer Hospital	Sayre	Pennsylvania
United States	Digestive Research Alliance of Michiana	South Bend	Indiana
United States	Premier Health Research LLC	Sparta	New Jersey
United States	Digestive Specialists Inc Research, LLC	Springboro	Ohio
United States	Clinical Trials Management Services LLC	Thousand Oaks	California
United States	Clinical Research Institute of Michigan	Troy	Michigan
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Digestive Research of Central Texas, LLC	Waco	Texas
United States	Digestive Health Research of North Texas LLC	Wichita Falls	Texas
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	West Michigan Clinical Research Center	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  Poland,  Romania,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Clinical Remission at Week 12		Week 12
Secondary	Number of Participants with Clinical Response at Week 12		Week 12
Secondary	Number of Participants with Endoscopic Remission at Week 12		Week 12
Secondary	Number of Participants with Symptomatic Remission at Week 12		Week 12
Secondary	Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12		Week 12
Secondary	Number of Participants with a Clinically Significant Change from Baseline in Histological Score at Week 12 as Measured by Geboes Score		Baseline to Week 12
Secondary	Number of Participants who Experience One or More Treatment-emergent Adverse Events		Up to 56 weeks

External Links

•   AmgenTrials clinical trials website