A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT02407236
Last Updated: 2025-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
961 participants
INTERVENTIONAL
2015-07-10
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Induction Study - Placebo Intravenous (IV)
Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.
Placebo IV
Placebo will be administered as intravenous infusion.
Induction Study - Ustekinumab 130 milligram (mg) IV
Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.
Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction Study - Ustekinumab 6 mg/kg IV
Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.
Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction Study- Placebo- Nonresponsders at Week 8
Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.
Placebo SC
Placebo will be administered Subcutaneously.
Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Induction study-Ustekinumab Nonresponders at Week 8
Participants without clinical response to ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.
Placebo IV
Placebo will be administered as intravenous infusion.
Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Maintenance Study - Placebo Subcutaneous (SC)
Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.
Placebo SC
Placebo will be administered Subcutaneously.
Maintenance Study - Ustekinumab 90mg SC every 12 weeks
Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.
Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w)
Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.
Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Maintenance Study - Placebo IV - Responder - Placebo SC
Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.
Placebo SC
Placebo will be administered Subcutaneously.
Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w
Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.
Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Interventions
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Placebo IV
Placebo will be administered as intravenous infusion.
Placebo SC
Placebo will be administered Subcutaneously.
Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal 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 tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine \[6-MP\] or azathioprine \[AZA\]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
* Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks
Exclusion Criteria
* 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 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
* Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Birmingham, Alabama, United States
La Mirada, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Torrance, California, United States
Vallejo, California, United States
Lone Tree, Colorado, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Suwanee, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Urbana, Illinois, United States
Indianapolis, Indiana, United States
Pratt, Kansas, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Houma, Louisiana, United States
Shreveport, Louisiana, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Chesterfield, Michigan, United States
Troy, Michigan, United States
Ypsilanti, Michigan, United States
Rochester, Minnesota, United States
Jackson, Mississippi, United States
Marlton, New Jersey, United States
Morristown, New Jersey, United States
Brooklyn, New York, United States
Mineola, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
The Bronx, New York, United States
Cincinnati, Ohio, United States
Mentor, Ohio, United States
Portland, Oregon, United States
Doylestown, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Sayre, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Roanoke, Virginia, United States
Seattle, Washington, United States
Bedford, , Australia
Clayton, , Australia
Concord, , Australia
Fitzroy, , Australia
Five Dock, , Australia
Garran, , Australia
Heidelberg, , Australia
Liverpool, , Australia
Melbourne, , Australia
South Brisbane, , Australia
Salzburg, , Austria
Vienna, , Austria
Antwerp, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselaere, , Belgium
Pleven, , Bulgaria
Rousse, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Brandon, Manitoba, Canada
Winnipeg, Manitoba, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Hradec Králové, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Aarhus, , Denmark
Odense, , Denmark
Amiens, , France
Bordeaux, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Pierre-Bénite, , France
Reims, , France
Rennes, , France
Saint-Etienne, , France
Toulouse, , France
Berlin, , Germany
Essen, , Germany
Freiburg im Breisgau, , Germany
Hanover, , Germany
Kiel, , Germany
Leipzig, , Germany
Lüneburg, , Germany
Mannheim, , Germany
Minden, , Germany
Münster, , Germany
Balatonfüred, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Miskolc, , Hungary
Mosonmagyaróvár, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Vác, , Hungary
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Petach Tikvah, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ageo-shi, , Japan
Asahikawa, , Japan
Bunkyō City, , Japan
Chiba, , Japan
Chikushinoshi, , Japan
Fujiidera, , Japan
Fukuoka-ken, , Japan
Higashi-Ibaraki, , Japan
Hirosaki, , Japan
Hiroshima, , Japan
Isesaki, , Japan
Izumo, , Japan
Kagoshima, , Japan
Kahoku, , Japan
Kobe, , Japan
Kochi, , Japan
Kurume, , Japan
Kyoto, , Japan
Midori-ku, , Japan
Nagasaki, , Japan
Nara, , Japan
Nishinomiya, , Japan
Numakunai, , Japan
Osaka, , Japan
Ōita, , Japan
Saga, , Japan
Saga-ken, , Japan
Saitama, , Japan
Sakura, , Japan
Sapporo, , Japan
Sendai, , Japan
Shizuoka, , Japan
Sunto-gun, , Japan
Takamatsu, , Japan
Tokorozawa, , Japan
Tokyo, , Japan
Toyama, , Japan
Toyota, , Japan
Tsu, , Japan
Tsuchiura, , Japan
Wakayama, , Japan
Yamanashi, , Japan
Amsterdam, , Netherlands
Maastricht, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Lower Hutt, , New Zealand
Milford, , New Zealand
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Puławy, , Poland
Sopot, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Oradea, , Romania
Romania, , Romania
Timișoara, , Romania
Irkutsk, , Russia
Kazan', , Russia
Moscow, , Russia
Moscva, , Russia
Novosibirsk, , Russia
Rostov-on-Don, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Ufa, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Vojvodina, , Serbia
Bratislava, , Slovakia
Prešov, , Slovakia
Daegu, , South Korea
Guri-si, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiyv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Sumy, , Ukraine
Uzhhorod, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Zhaporozhia, , Ukraine
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Coventry, , United Kingdom
Doncaster, , United Kingdom
Edinburgh, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Southampton, , United Kingdom
Sutton in Ashfield, , United Kingdom
Countries
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References
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Danese S, Leong RW, Sands BE, Ma T, Marano C, Peyrin-Biroulet L. Clinical Trial: Association Between Early Disease Clearance and Long-Term Outcomes-4-Year Results From the Phase 3 UNIFI Study of Ustekinumab in Ulcerative Colitis. Aliment Pharmacol Ther. 2025 Sep;62(5):483-492. doi: 10.1111/apt.70264. Epub 2025 Jul 16.
Solitano V, Panaccione R, Sands BE, Wang Z, Hogan M, Zou G, Peyrin-Biroulet L, Danese S, Cornfield LJ, Feagan BG, Singh S, Jairath V, Ma C. Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis. Med. 2025 Feb 14;6(2):100512. doi: 10.1016/j.medj.2024.09.001. Epub 2024 Oct 4.
Ghosh 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.
Afif W, Arasaradnam RP, Abreu MT, Danese S, Sandborn WJ, Miao Y, Zhang H, Panaccione R, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Peyrin-Biroulet L, Sands BE, Marano C. Efficacy and Safety of Ustekinumab for Ulcerative Colitis Through 4 Years: Final Results of the UNIFI Long-Term Maintenance Study. Am J Gastroenterol. 2024 May 1;119(5):910-921. doi: 10.14309/ajg.0000000000002621. Epub 2023 Dec 14.
Chen R, Li L, Tie Y, Chen M, Zhang S. Trajectory of fecal lactoferrin for predicting prognosis in ulcerative colitis. Precis Clin Med. 2023 Sep 5;6(3):pbad022. doi: 10.1093/pcmedi/pbad022. eCollection 2023 Sep.
Danese S, Sands BE, Abreu MT, O'Brien CD, Bravata I, Nazar M, Miao Y, Wang Y, Rowbotham D, Leong RWL, Arasaradnam RP, Afif W, Marano C. Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2858-2867.e5. doi: 10.1016/j.cgh.2022.02.050. Epub 2022 Mar 8.
Panaccione R, Danese S, Sandborn WJ, O'Brien CD, Zhou Y, Zhang H, Adedokun OJ, Tikhonov I, Targan S, Abreu MT, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Arasaradnam RP, Sands BE, Marano C. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. Epub 2020 Oct 21.
Sandborn 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.
Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology. 2020 Dec;159(6):2052-2064. doi: 10.1053/j.gastro.2020.08.037. Epub 2020 Aug 25.
Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-005606-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNTO1275UCO3001
Identifier Type: OTHER
Identifier Source: secondary_id
CR106920
Identifier Type: -
Identifier Source: org_study_id
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