A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
3 other identifiers
interventional
1,282
25 countries
218
Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Longer than P75 for phase_3
218 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
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedStudy Start
First participant enrolled
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2015
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFebruary 4, 2025
January 1, 2025
3.7 years
June 7, 2011
October 17, 2016
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Remission at Week 44
Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Week 44
Secondary Outcomes (4)
Number of Participants With Clinical Response at Week 44
Week 44
Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study
Week 44
Number of Participants With Corticosteroid-free Remission at Week 44
Week 44
Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
Week 44
Study Arms (6)
001
PLACEBO COMPARATORParticipants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w).
002
EXPERIMENTALParticipants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w).
003
EXPERIMENTALParticipants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w).
004
EXPERIMENTALParticipants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w.
005
EXPERIMENTALParticipants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w.
006
PLACEBO COMPARATORParticipants who were responders to IV placebo induction will receive one dose of placebo SC q4w.
Interventions
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
Eligibility Criteria
You may not qualify if:
- Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002
- Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
- Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (220)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Carlos, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Lone Tree, Colorado, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Boca Raton, Florida, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Naples, Florida, United States
Unknown Facility
Weston, Florida, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Idaho Falls, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Evanston, Illinois, United States
Unknown Facility
Clive, Iowa, United States
Unknown Facility
Pratt, Kansas, United States
Unknown Facility
Crestview Hills, Kentucky, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Baton Rouge, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Chevy Chase, Maryland, United States
Unknown Facility
Towson, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Chesterfield, Michigan, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
Ypsilanti, Michigan, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Ocean Springs, Mississippi, United States
Unknown Facility
Columbia, Missouri, United States
Unknown Facility
Lee's Summit, Missouri, United States
Unknown Facility
Urbana, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Lebanon, New Hampshire, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Great Neck, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Poughkeepsie, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Mentor, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Bend, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
North Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Grapevine, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Tyler, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Chesapeake, Virginia, United States
Unknown Facility
Virginia Beach, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Bedford Park, Australia
Unknown Facility
Box Hill, Australia
Unknown Facility
Central Queensland M C, Australia
Unknown Facility
Concord, Australia
Unknown Facility
Garran, Australia
Unknown Facility
Liverpool, Australia
Unknown Facility
Malvern, Australia
Unknown Facility
Parkville, Australia
Unknown Facility
Innsbruck, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Brussels, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Goiânia, Brazil
Unknown Facility
Porto Alegre, Brazil
Unknown Facility
Rio de Janeiro, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Pleven, Bulgaria
Unknown Facility
Rousse, Bulgaria
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Brandon, Manitoba, Canada
Unknown Facility
Winnipeg, Manitoba, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
Kingston, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Saskatoon, Saskatchewan, Canada
Unknown Facility
Rijeka, Croatia
Unknown Facility
Zagreb, Croatia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Unknown Facility
Herlev, Denmark
Unknown Facility
Silkeborg, Denmark
Unknown Facility
Lille, France
Unknown Facility
Marseille, France
Unknown Facility
Paris, France
Unknown Facility
Pessac, France
Unknown Facility
Reims, France
Unknown Facility
Rouen, France
Unknown Facility
Toulouse, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Berlin, Germany
Unknown Facility
Erlangen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Halle, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Haßloch, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Jena, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
LÿNEBURG, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
München, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Regensburg, Germany
Unknown Facility
Stade, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Békéscsaba, Hungary
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Mosonmagyaróvár, Hungary
Unknown Facility
Pécs, Hungary
Unknown Facility
Szeksz Rd N/a, Hungary
Unknown Facility
Székesfehérvár, Hungary
Unknown Facility
Reykjavik, Iceland
Unknown Facility
Dublin, Ireland
Unknown Facility
Jerusalem, Israel
Unknown Facility
Kfar Saba, Israel
Unknown Facility
Petah Tikva, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Rehovot, Israel
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Tzrifin, Israel
Unknown Facility
Chikushino-shi, Japan
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hachiōji, Japan
Unknown Facility
Hamamatsu, Japan
Unknown Facility
Hirosaki, Japan
Unknown Facility
Hiroshima, Japan
Unknown Facility
Kagoshima, Japan
Unknown Facility
Nishinomiya, Japan
Unknown Facility
Ohtsu, Japan
Unknown Facility
Osaka, Japan
Unknown Facility
Ōita, Japan
Unknown Facility
Sakura, Japan
Unknown Facility
Sapporo, Japan
Unknown Facility
Sendai, Japan
Unknown Facility
Suita-shi, Japan
Unknown Facility
Tokyo, Japan
Unknown Facility
Tsu, Japan
Unknown Facility
Uruma, Japan
Unknown Facility
Yokkaichi, Japan
Unknown Facility
Yokohama, Japan
Unknown Facility
Yokosuka, Japan
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Maastricht, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Auckland, New Zealand
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Dunedin, New Zealand
Unknown Facility
Grafton, New Zealand
Unknown Facility
Hamilton, New Zealand
Unknown Facility
Hastings, New Zealand
Unknown Facility
Plenty, New Zealand
Unknown Facility
Elblag, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Moscow, Russia
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Belgrade, Serbia
Unknown Facility
Cape Town, South Africa
Unknown Facility
Cape Town Western Cape, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Somerset West, South Africa
Unknown Facility
Daegu, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Madrid, Spain
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Brighton, United Kingdom
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Cambridge, United Kingdom
Unknown Facility
Cardiff, United Kingdom
Unknown Facility
Exeter, United Kingdom
Unknown Facility
Gloucester, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Norwich, United Kingdom
Unknown Facility
Nottinghamshirecc, United Kingdom
Unknown Facility
Oxford, United Kingdom
Unknown Facility
Shropshire, United Kingdom
Unknown Facility
Southampton, United Kingdom
Related Publications (16)
Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
PMID: 40357993DERIVEDGhosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C, Miao Y, Ma T, Loftus EV Jr, Sandborn WJ, Danese S, Abreu MT, Sands BE. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis. J Crohns Colitis. 2024 Aug 6;18(7):1091-1101. doi: 10.1093/ecco-jcc/jjae013.
PMID: 38310565DERIVEDColombel JF, Sands BE, Gasink C, Yeager B, Adedokun OJ, Izanec J, Ma T, Gao LL, Lee SD, Targan SR, Ghosh S, Hanauer SB, Sandborn WJ. Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2024 Jan;22(1):144-153.e2. doi: 10.1016/j.cgh.2023.06.014. Epub 2023 Jun 28.
PMID: 37391056DERIVEDDubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27.
PMID: 37368103DERIVEDAdedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.
PMID: 36150926DERIVEDNarula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.
PMID: 34077627DERIVEDSandborn WJ, Rebuck R, Wang Y, Zou B, Adedokun OJ, Gasink C, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG, Lynch JP. Five-Year Efficacy and Safety of Ustekinumab Treatment in Crohn's Disease: The IM-UNITI Trial. Clin Gastroenterol Hepatol. 2022 Mar;20(3):578-590.e4. doi: 10.1016/j.cgh.2021.02.025. Epub 2021 Feb 19.
PMID: 33618023DERIVEDSandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236.
PMID: 32964215DERIVEDLi K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.
PMID: 31279870DERIVEDHanauer SB, Sandborn WJ, Feagan BG, Gasink C, Jacobstein D, Zou B, Johanns J, Adedokun OJ, Sands BE, Rutgeerts P, de Villiers WJS, Colombel JF, Ghosh S. IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. J Crohns Colitis. 2020 Jan 1;14(1):23-32. doi: 10.1093/ecco-jcc/jjz110.
PMID: 31158271DERIVEDGhosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
PMID: 30739254DERIVEDRutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.
PMID: 29909019DERIVEDSandborn WJ, Rutgeerts P, Gasink C, Jacobstein D, Zou B, Johanns J, Sands BE, Hanauer SB, Targan S, Ghosh S, de Villiers WJS, Colombel JF, Feagan BG. Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy. Aliment Pharmacol Ther. 2018 Jul;48(1):65-77. doi: 10.1111/apt.14794. Epub 2018 May 24.
PMID: 29797519DERIVEDAdedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.
PMID: 29409871DERIVEDHibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.
PMID: 29142515DERIVEDFeagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773.
PMID: 27959607DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The global study was interrupted due to issues with the clinical supply.
Results Point of Contact
- Title
- Vice President
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 8, 2011
Study Start
September 13, 2011
Primary Completion
June 10, 2015
Study Completion
October 1, 2019
Last Updated
February 4, 2025
Results First Posted
February 23, 2017
Record last verified: 2025-01