A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
219
14 countries
97
Brief Summary
The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedStudy Start
First participant enrolled
November 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2015
CompletedJanuary 4, 2019
January 1, 2019
1.5 years
October 7, 2013
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Mayo score at Week 8
The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.
Week 8
Secondary Outcomes (3)
Number of participants with clinical response at Week 8
Week 8
Number of participants with clinical remission at Week 8
Week 8
Number of participants with mucosal healing at Week 8
Week 8
Study Arms (5)
Placebo
PLACEBO COMPARATORParticipants will receive placebo once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive placebo through Week 32. Participants not in clinical response at Week 8 will receive treatment with 150 mg JNJ-54781532 orally once daily from Week 8 to Week 16. Participants who achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) at Week 16 can continue receiving 150 mg JNJ-54781532 orally once daily through Week 32
JNJ-54781532 25 mg once daily
EXPERIMENTALParticipants will receive 25 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 25 mg once daily through Week 32
JNJ-54781532 75 mg once daily
EXPERIMENTALParticipants will receive 75 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg once daily through Week 32
JNJ-54781532 150 mg once daily
EXPERIMENTALParticipants will receive 150 mg of JNJ-54781532 once daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 150 mg once daily through Week 32
JNJ-54781532 75 mg twice daily
EXPERIMENTALParticipants will receive 75 mg of JNJ-54781532 twice daily from Week 0 to Week 8. Participants in clinical response at Week 8 will continue to receive the same dosage through Week 32 and participants not in clinical response at Week 8 will continue to receive the same dosage through Week 16. At Week 16, participants who do not achieve a partial Mayo score response (ie, a change from baseline of ≥3 in the partial Mayo score) will be discontinued from study medication, and participants who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 75 mg twice daily through Week 32
Interventions
Participants will receive 25 mg of JNJ-54781532 once daily
Participants will receive 75 mg of JNJ-54781532 once daily
Participants will receive 150 mg of JNJ-54781532 once daily
Participants will receive 75 mg of JNJ-54781532 twice daily
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening
- Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12; including an endoscopy sub score greater than or equal to 2 as determined by a central read of the video endoscopy
- Current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-MP), azathioprine (AZA), or anti- tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
- Must discontinue 6-MP/AZA for at least 1 week before the first dose of study medication
You may not qualify if:
- At imminent risk for colectomy
- Have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon
- Presence of a stoma
- Presence or history of a fistula
- History or current diagnosis of active or latent tuberculosis; human immunodeficiency virus; hepatitis C virus or hepatitis B virus infection; have had more than 1 herpes zoster infection or have had any diagnosis of disseminated herpes zoster
- Previous treatment with a janus kinase inhibitor (eg, tofacitinib)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
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La Jolla, California, United States
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Thornton, Colorado, United States
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Ann Arbor, Michigan, United States
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Tupelo, Mississippi, United States
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Egg Harbor, New Jersey, United States
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Salisbury, North Carolina, United States
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Cleveland, Ohio, United States
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Lima, Ohio, United States
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Norman, Oklahoma, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Bankstown, Australia
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Bedford, Australia
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Concord, Australia
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Herston, Australia
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Launceston, Australia
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Melbourne, Australia
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Penrith, Australia
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South Brisbane, Australia
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Brussels, Belgium
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Ghent, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Pleven, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Greater Sudbury, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Lille, France
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Paris, France
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Pessac, France
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Berlin, Germany
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Essen, Germany
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Frankfurt A. M., Germany
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Hanover, Germany
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Heidelberg, Germany
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Herne, Germany
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Jena, Germany
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Kiel, Germany
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Magdeburg, Germany
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Münster, Germany
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Neustadt, Germany
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Stade, Germany
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Békéscsaba, Hungary
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Budapest, Hungary
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Mosonmagyaróvár, Hungary
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Szekszárd, Hungary
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Hadera, Israel
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Haifa, Israel
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Jerusalem, Israel
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Nazareth, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Amsterdam, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Elblag, Poland
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Lodz, Poland
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Sopot, Poland
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Warsaw, Poland
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Bucharest, Romania
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Constanța, Romania
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Iași, Romania
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Timișoara, Romania
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Kazan’, Russia
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Nizny Novgorod, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Rostov-on-Don, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Stavropol, Russia
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Ufa, Russia
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Yaroslavl, Russia
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Donetsk, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Ternopil, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhia, Ukraine
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Zhaporozhia 69104, Ukraine
Related Publications (2)
Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.
PMID: 30721964DERIVEDSands BE, Sandborn WJ, Feagan BG, Lichtenstein GR, Zhang H, Strauss R, Szapary P, Johanns J, Panes J, Vermeire S, O'Brien CD, Yang Z, Bertelsen K, Marano C; Peficitinib-UC Study Group. Peficitinib, an Oral Janus Kinase Inhibitor, in Moderate-to-severe Ulcerative Colitis: Results From a Randomised, Phase 2 Study. J Crohns Colitis. 2018 Nov 9;12(10):1158-1169. doi: 10.1093/ecco-jcc/jjy085.
PMID: 29917064DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
October 7, 2013
First Posted
October 10, 2013
Study Start
November 15, 2013
Primary Completion
May 20, 2015
Study Completion
December 5, 2015
Last Updated
January 4, 2019
Record last verified: 2019-01