A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Gastrointestinal Diseases And Disorders

Treatment

Placebo SC

Placebo IV

Ustekinumab SC

Clinical Study ID

NCT02407236
CR106920
CNTO1275UCO3001
2014-005606-38
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months beforeScreening

  • Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6to 12, including a Screening endoscopy subscore of the Mayo score greater than orequal to (>=) 2 as determined by a central reading of the video endoscopy

  • Have failed biologic therapy, that is, have received treatment with 1 or more tumournecrosis factor (TNF) antagonists or vedolizumab at a dose approved for thetreatment of UC, and have a documented history of failure to respond to or toleratesuch treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) orhave received biologic therapy but have not demonstrated a history of failure torespond to, or tolerate, a biologic therapy and have a prior or current UCmedication history that includes at least 1 of the following: a. Inadequate responseto or failure to tolerate current treatment with oral corticosteroids orimmunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History offailure to respond to, or tolerate, at least 1 of the following therapies: oral orIV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroiddependence (that is, an inability to successfully taper corticosteroids without areturn of the symptoms of UC)

  • Before the first administration of study agent, the following conditions must bemet: vedolizumab must have been discontinued for at least 4 months and anti-tumornecrosis factors (TNFs) for at least 8 weeks

Exclusion

Exclusion Criteria:

  • Has severe extensive colitis and is at imminent risk of colectomy

  • Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon

  • Presence of a stoma or history of a fistula

  • Participants with history of extensive colonic resection (for example, less than 30cm of colon remaining) that would prevent adequate evaluation of the effect of studyagent on clinical disease activity

  • Participants with history of colonic mucosal dysplasia. Participants will not beexcluded from the study because of a pathology finding of "indefinite dysplasia withreactive atypia''

Study Design

Total Participants: 961
Treatment Group(s): 4
Primary Treatment: Placebo SC
Phase: 3
Study Start date:
July 10, 2015
Estimated Completion Date:
November 30, 2021

Study Description

This is a Phase 3, randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), multi-center (more than one clinical site will work on a medical research study), protocol of ustekinumab. The protocol will consist of 2 studies: an Induction study and a Maintenance study with unique endpoints. Screening period will be up to 8 Weeks. Induction study will be at least 8 weeks duration for each participant. Participant with clinical response in the Induction study will be eligible for the Maintenance study. The Maintenance study will be 44 weeks duration. After completion of the maintenance study, a long term extension will follow eligible participants for an additional 3 years. Clinical remission will be evaluated at Week 8 in the Induction study. Clinical remission among ustekinumab Induction responders will be evaluated at week 44 in the Maintenance study. Participants' safety will be monitored throughout.

Connect with a study center

  • University of NSW - Bankstown-Lidcombe Hospital

    Bankstown, 2200
    Australia

    Site Not Available

  • Bedford,
    Australia

    Site Not Available

  • BOX HILL

    Box Hill, 3128
    Australia

    Site Not Available

  • Nambour General Hospital

    Central Queensland M C, 4560
    Australia

    Site Not Available

  • Clayton,
    Australia

    Site Not Available

  • Concord N/a,
    Australia

    Site Not Available

  • Fitzroy,
    Australia

    Site Not Available

  • Five Dock,
    Australia

    Site Not Available

  • Garran,
    Australia

    Site Not Available

  • Heidelberg,
    Australia

    Site Not Available

  • Liverpool,
    Australia

    Site Not Available

  • Melbourne,
    Australia

    Site Not Available

  • Royal Melbourne

    Parkville,
    Australia

    Site Not Available

  • South Brisbane,
    Australia

    Site Not Available

  • Salzburg,
    Austria

    Site Not Available

  • Krankenhaus der Barmherzigen Brueder St. Veit

    St Veit An Der Glan, 9300
    Austria

    Site Not Available

  • Wien,
    Austria

    Site Not Available

  • Antwerpen,
    Belgium

    Site Not Available

  • Gent,
    Belgium

    Site Not Available

  • Kortrijk,
    Belgium

    Site Not Available

  • Leuven,
    Belgium

    Site Not Available

  • Liege,
    Belgium

    Site Not Available

  • Liège,
    Belgium

    Site Not Available

  • Roeselaere,
    Belgium

    Site Not Available

  • Pleven,
    Bulgaria

    Site Not Available

  • Rousse,
    Bulgaria

    Site Not Available

  • Sevlievo,
    Bulgaria

    Site Not Available

  • Sofia,
    Bulgaria

    Site Not Available

  • Varna,
    Bulgaria

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Victoria, British Columbia
    Canada

    Site Not Available

  • Brandon, Manitoba
    Canada

    Site Not Available

  • Winnipeg, Manitoba
    Canada

    Site Not Available

  • London, Ontario
    Canada

    Site Not Available

  • Sudbury, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Hradec Kralove,
    Czechia

    Site Not Available

  • Plzen,
    Czechia

    Site Not Available

  • Prague 4,
    Czechia

    Site Not Available

  • Praha 5,
    Czechia

    Site Not Available

  • Praha 7,
    Czechia

    Site Not Available

  • NH Hospital, a.s.

    Praha 8, 180 81
    Czechia

    Site Not Available

  • Praha 9,
    Czechia

    Site Not Available

  • Aarhus,
    Denmark

    Site Not Available

  • Odense,
    Denmark

    Site Not Available

  • Amiens,
    France

    Site Not Available

  • Bordeaux,
    France

    Site Not Available

  • Lille,
    France

    Site Not Available

  • Lyon,
    France

    Site Not Available

  • Marseille,
    France

    Site Not Available

  • Montpellier,
    France

    Site Not Available

  • Hopital Saint-Antoine

    Paris, 75012
    France

    Site Not Available

  • Pierre-Benite,
    France

    Site Not Available

  • Reims,
    France

    Site Not Available

  • Rennes,
    France

    Site Not Available

  • Saint-Etienne,
    France

    Site Not Available

  • Toulouse,
    France

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Klinikum Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Essen,
    Germany

    Site Not Available

  • Freiburg,
    Germany

    Site Not Available

  • Hannover,
    Germany

    Site Not Available

  • Kiel,
    Germany

    Site Not Available

  • Leipzig,
    Germany

    Site Not Available

  • Lüneburg,
    Germany

    Site Not Available

  • Mannheim,
    Germany

    Site Not Available

  • Minden,
    Germany

    Site Not Available

  • Münster,
    Germany

    Site Not Available

  • Balatonfüred,
    Hungary

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Békéscsaba,
    Hungary

    Site Not Available

  • Debrecen,
    Hungary

    Site Not Available

  • Miskolc,
    Hungary

    Site Not Available

  • Mosonmagyarovar,
    Hungary

    Site Not Available

  • Szekszárd,
    Hungary

    Site Not Available

  • Szombathely,
    Hungary

    Site Not Available

  • Székesfehérvár,
    Hungary

    Site Not Available

  • Vac,
    Hungary

    Site Not Available

  • Ha'Emek Medical Center

    Afula, 18101
    Israel

    Site Not Available

  • Beersheba,
    Israel

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Holon,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Kfar-Saba,
    Israel

    Site Not Available

  • Nahariya,
    Israel

    Site Not Available

  • Petach Tikvah,
    Israel

    Site Not Available

  • Tel Aviv,
    Israel

    Site Not Available

  • Tel Hashomer,
    Israel

    Site Not Available

  • Ageo-shi,
    Japan

    Site Not Available

  • Asahikawa,
    Japan

    Site Not Available

  • Bunkyo Ku,
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Bunkyo-Ku, 113-8519
    Japan

    Site Not Available

  • Bunkyo-Ku,
    Japan

    Site Not Available

  • Chiba,
    Japan

    Site Not Available

  • Chikushinoshi,
    Japan

    Site Not Available

  • Fujiidera,
    Japan

    Site Not Available

  • Fukuoka-ken,
    Japan

    Site Not Available

  • Higashi-Ibaraki,
    Japan

    Site Not Available

  • Hirosaki,
    Japan

    Site Not Available

  • Hiroshima,
    Japan

    Site Not Available

  • Isesaki,
    Japan

    Site Not Available

  • Iwate,
    Japan

    Site Not Available

  • Izumo,
    Japan

    Site Not Available

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557
    Japan

    Site Not Available

  • Kagawa,
    Japan

    Site Not Available

  • Kagoshima,
    Japan

    Site Not Available

  • Kahoku,
    Japan

    Site Not Available

  • Ibaraki Prefectural Central Hospital

    Kasama, 309-1703
    Japan

    Site Not Available

  • Kobe-shi,
    Japan

    Site Not Available

  • Kochi,
    Japan

    Site Not Available

  • Kurume,
    Japan

    Site Not Available

  • Kyoto,
    Japan

    Site Not Available

  • Midori-ku,
    Japan

    Site Not Available

  • Nagasaki,
    Japan

    Site Not Available

  • Nara,
    Japan

    Site Not Available

  • Nishinomiya,
    Japan

    Site Not Available

  • Oita,
    Japan

    Site Not Available

  • Osaka,
    Japan

    Site Not Available

  • Saga,
    Japan

    Site Not Available

  • Saga-ken,
    Japan

    Site Not Available

  • Saitama,
    Japan

    Site Not Available

  • Sakura,
    Japan

    Site Not Available

  • Sapporo,
    Japan

    Site Not Available

  • Sendai,
    Japan

    Site Not Available

  • Shizuoka,
    Japan

    Site Not Available

  • Sunto-gun,
    Japan

    Site Not Available

  • Takamatsu,
    Japan

    Site Not Available

  • Tokorozawa,
    Japan

    Site Not Available

  • Tokyo,
    Japan

    Site Not Available

  • Toyama,
    Japan

    Site Not Available

  • Toyota,
    Japan

    Site Not Available

  • Tsu,
    Japan

    Site Not Available

  • Tsuchiura,
    Japan

    Site Not Available

  • Wakayama,
    Japan

    Site Not Available

  • Yamanashi,
    Japan

    Site Not Available

  • Daegu,
    Korea, Republic of

    Site Not Available

  • Guri-si,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Suwon-si,
    Korea, Republic of

    Site Not Available

  • Amsterdam,
    Netherlands

    Site Not Available

  • Maastricht,
    Netherlands

    Site Not Available

  • Auckland,
    New Zealand

    Site Not Available

  • Christchurch,
    New Zealand

    Site Not Available

  • Dunedin,
    New Zealand

    Site Not Available

  • Lower Hutt,
    New Zealand

    Site Not Available

  • Milford,
    New Zealand

    Site Not Available

  • Gdansk,
    Poland

    Site Not Available

  • Krakow,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Pulawy,
    Poland

    Site Not Available

  • Sopot,
    Poland

    Site Not Available

  • Szczecin,
    Poland

    Site Not Available

  • Warszawa,
    Poland

    Site Not Available

  • Wroclaw,
    Poland

    Site Not Available

  • Bucuresti,
    Romania

    Site Not Available

  • Oradea,
    Romania

    Site Not Available

  • Romania,
    Romania

    Site Not Available

  • Timisoara,
    Romania

    Site Not Available

  • Irkutsk,
    Russian Federation

    Site Not Available

  • empty

    Karzan,
    Russian Federation

    Site Not Available

  • Kazan,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Moscva,
    Russian Federation

    Site Not Available

  • Novosibirsk,
    Russian Federation

    Site Not Available

  • Omsk state medical academy

    Omsk, 644099
    Russian Federation

    Site Not Available

  • Rostov-on-Don,
    Russian Federation

    Site Not Available

  • Ryazan,
    Russian Federation

    Site Not Available

  • Saint Petersburg,
    Russian Federation

    Site Not Available

  • St Petersburg,
    Russian Federation

    Site Not Available

  • St.-Petersburg,
    Russian Federation

    Site Not Available

  • Stavropol,
    Russian Federation

    Site Not Available

  • Ufa,
    Russian Federation

    Site Not Available

  • Belgrade,
    Serbia

    Site Not Available

  • Kragujevac,
    Serbia

    Site Not Available

  • Nis,
    Serbia

    Site Not Available

  • empty

    Novi Sad,
    Serbia

    Site Not Available

  • Vojvodina,
    Serbia

    Site Not Available

  • Bratislava,
    Slovakia

    Site Not Available

  • Presov,
    Slovakia

    Site Not Available

  • UVN SNP Ruzomberok - FN

    Ruzomberok, 034 26
    Slovakia

    Site Not Available

  • empty

    Cape Town,
    South Africa

    Site Not Available

  • empty

    Claremont,
    South Africa

    Site Not Available

  • empty

    Durban,
    South Africa

    Site Not Available

  • empty

    Soweto,
    South Africa

    Site Not Available

  • Chernivtsi,
    Ukraine

    Site Not Available

  • Dnipropetrovsk,
    Ukraine

    Site Not Available

  • Ivano-Frankivsk,
    Ukraine

    Site Not Available

  • Kharkiv,
    Ukraine

    Site Not Available

  • Kiyv,
    Ukraine

    Site Not Available

  • Kyiv,
    Ukraine

    Site Not Available

  • Lviv,
    Ukraine

    Site Not Available

  • Odessa,
    Ukraine

    Site Not Available

  • Sumy,
    Ukraine

    Site Not Available

  • Uzhgorod,
    Ukraine

    Site Not Available

  • Vinnytsia,
    Ukraine

    Site Not Available

  • Zaporizhzhia,
    Ukraine

    Site Not Available

  • Zhaporozhia,
    Ukraine

    Site Not Available

  • Tameside Hosptial NHS Foundation Trust

    Ashton Under Lyne, OL6 9RW
    United Kingdom

    Site Not Available

  • Birmingham,
    United Kingdom

    Site Not Available

  • Cambridge,
    United Kingdom

    Site Not Available

  • Coventry,
    United Kingdom

    Site Not Available

  • Doncaster,
    United Kingdom

    Site Not Available

  • Edinburgh,
    United Kingdom

    Site Not Available

  • Liverpool,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Royal Gwent Hospital

    Newport, NP20 2UB
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Salford,
    United Kingdom

    Site Not Available

  • Southampton,
    United Kingdom

    Site Not Available

  • Sutton In Ashfield,
    United Kingdom

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Mobile Medical And Diagnostic Center

    Mobile, Alabama 36617
    United States

    Site Not Available

  • Adobe Clinical Research LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Scripps Clinic La Jolla

    La Jolla, California 92037
    United States

    Site Not Available

  • La Mirada, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Newport Beach, California
    United States

    Site Not Available

  • empty

    Newport Bech, California
    United States

    Site Not Available

  • Weisman Medical Group

    Palo Alto, California 94304
    United States

    Site Not Available

  • Torrance, California
    United States

    Site Not Available

  • Vallejo, California
    United States

    Site Not Available

  • Lone Tree, Colorado
    United States

    Site Not Available

  • Connecticut Gastroenterology Institute at Bristol Hospital

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Farmington, Connecticut
    United States

    Site Not Available

  • empty

    Glastonbury, Connecticut
    United States

    Site Not Available

  • Chase Medical Research LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Washington, District of Columbia
    United States

    Site Not Available

  • empty

    Washington, D.C., District of Columbia
    United States

    Site Not Available

  • Zasa Clinical Research

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Clinical Trials Management of Boca Raton Inc.

    Boca Raton, Florida 33428
    United States

    Site Not Available

  • Gainesville, Florida
    United States

    Site Not Available

  • Largo, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Port Orange, Florida
    United States

    Site Not Available

  • Tampa, Florida
    United States

    Site Not Available

  • Winter Park, Florida
    United States

    Site Not Available

  • Zephyrhills, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Decatur, Georgia
    United States

    Site Not Available

  • Macon, Georgia
    United States

    Site Not Available

  • Suwanee, Georgia
    United States

    Site Not Available

  • Idaho Falls, Idaho
    United States

    Site Not Available

  • Northwest Gastroenterologists S.C.

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Evanston, Illinois
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Urbana, Illinois
    United States

    Site Not Available

  • Indianapolis, Indiana
    United States

    Site Not Available

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Pratt, Kansas
    United States

    Site Not Available

  • Crestview Hills, Kentucky
    United States

    Site Not Available

  • Lexington, Kentucky
    United States

    Site Not Available

  • Louisville, Kentucky
    United States

    Site Not Available

  • Houma, Louisiana
    United States

    Site Not Available

  • Shreveport, Louisiana
    United States

    Site Not Available

  • Columbia, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Ann Arbor, Michigan
    United States

    Site Not Available

  • Chesterfield, Michigan
    United States

    Site Not Available

  • Troy, Michigan
    United States

    Site Not Available

  • Ypsilanti, Michigan
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Jackson, Mississippi
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Marlton, New Jersey
    United States

    Site Not Available

  • Morristown, New Jersey
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • Brooklyn, New York
    United States

    Site Not Available

  • Mineola, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Poughkeepsie, New York
    United States

    Site Not Available

  • Stony Brook University Medical Center - NY

    Stony Brook, New York 11794
    United States

    Site Not Available

  • empty

    The Bronx, New York
    United States

    Site Not Available

  • Cincinnati, Ohio
    United States

    Site Not Available

  • Mentor, Ohio
    United States

    Site Not Available

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Doylestown, Pennsylvania
    United States

    Site Not Available

  • Hershey, Pennsylvania
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Sayre, Pennsylvania
    United States

    Site Not Available

  • Southeast Medical Research

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Chattanooga Medical Research

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Germantown, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Austin Gastroenterology, PA

    Austin, Texas 78745
    United States

    Site Not Available

  • Research Concepts

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Brooke Army Medical Center

    Fort Sam Houston, Texas 78234
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Irving, Texas
    United States

    Site Not Available

  • Darnall Army Comm Hospital Internal Medicine

    Killeen, Texas 76544
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Southlake, Texas
    United States

    Site Not Available

  • Tyler, Texas
    United States

    Site Not Available

  • Aspen Clinical Research

    Orem, Utah 84058
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

  • West Jordan, Utah
    United States

    Site Not Available

  • University Of Vermont - Fletcher Allen Healthcare

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Chesapeake, Virginia
    United States

    Site Not Available

  • Fairfax, Virginia
    United States

    Site Not Available

  • Roanoke, Virginia
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

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