A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
UNIFI
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
961
22 countries
237
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
Longer than P75 for phase_3
237 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
March 30, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedStudy Start
First participant enrolled
July 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2018
CompletedResults Posted
Study results publicly available
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedApril 29, 2025
April 1, 2025
3.1 years
March 30, 2015
November 15, 2019
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
As per global definition, clinical remission is defined as a Mayo score less than or equal to (\<=)2 points, with no individual subscore greater than (\>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding \[RB\], endoscopy findings, and physician's global assessment \[PGA\]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Week 8
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
As per US definition, clinical remission was defined as absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Week 8
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
As per global definition, clinical remission was defined as a Mayo score \<=2 points, with no individual subscore \>1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Week 44
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
Per US definition, clinical remission: absolute stool number \<=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease \[erythema, decreased vascular pattern, mild friability\]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Week 44
Secondary Outcomes (71)
Induction Study: Number of Participants With Endoscopic Healing at Week 8
Week 8
Induction Study: Number of Participants With Clinical Response at Week 8
Week 8
Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Baseline and Week 8
Maintenance Study: Number of Participants With Clinical Response up to Week 44
Up to Week 44
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
Week 44
- +66 more secondary outcomes
Study Arms (10)
Induction Study - Placebo Intravenous (IV)
PLACEBO COMPARATORParticipants 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.
Induction Study - Ustekinumab 130 milligram (mg) IV
EXPERIMENTALParticipants 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.
Induction Study - Ustekinumab 6 mg/kg IV
EXPERIMENTALParticipants 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.
Induction Study- Placebo- Nonresponsders at Week 8
OTHERParticipants 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.
Induction study-Ustekinumab Nonresponders at Week 8
OTHERParticipants 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.
Maintenance Study - Placebo Subcutaneous (SC)
PLACEBO COMPARATORParticipants 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.
Maintenance Study - Ustekinumab 90mg SC every 12 weeks
EXPERIMENTALParticipants 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.
Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w)
EXPERIMENTALParticipants 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.
Maintenance Study - Placebo IV - Responder - Placebo SC
OTHERParticipants 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.
Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w
OTHERParticipants 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.
Interventions
Placebo will be administered as intravenous infusion.
Placebo will be administered Subcutaneously.
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.
Ustekinumab will be administered as subcutaneously.
Eligibility Criteria
You may qualify if:
- Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
- 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
You may not qualify if:
- 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 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''
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (247)
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Birmingham, Alabama, United States
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La Mirada, California, United States
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Romania, Romania
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Timișoara, Romania
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Irkutsk, Russia
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Ufa, Russia
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Daegu, South Korea
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Birmingham, United Kingdom
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Sutton in Ashfield, United Kingdom
Related Publications (10)
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.
PMID: 40668079DERIVEDSolitano 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.
PMID: 39368474DERIVEDGhosh 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: 38310565DERIVEDAfif 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.
PMID: 38095692DERIVEDChen 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.
PMID: 38025971DERIVEDDanese 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.
PMID: 35276329DERIVEDPanaccione 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.
PMID: 33086438DERIVEDSandborn 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, 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.
PMID: 32853634DERIVEDSands 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.
PMID: 31553833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development
- 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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2015
First Posted
April 2, 2015
Study Start
July 10, 2015
Primary Completion
August 10, 2018
Study Completion
November 30, 2021
Last Updated
April 29, 2025
Results First Posted
December 23, 2019
Record last verified: 2025-04