A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT01959282
Last Updated: 2019-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
219 participants
INTERVENTIONAL
2013-11-15
2015-12-05
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
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants 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
Placebo
Participants will receive placebo once daily
JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily
JNJ-54781532 25 mg once daily
Participants 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 25 mg once daily
Participants will receive 25 mg of JNJ-54781532 once daily
JNJ-54781532 75 mg once daily
Participants 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 75 mg once daily
Participants will receive 75 mg of JNJ-54781532 once daily
JNJ-54781532 150 mg once daily
Participants 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 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily
JNJ-54781532 75 mg twice daily
Participants 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
JNJ-54781532 75 mg twice daily
Participants will receive 75 mg of JNJ-54781532 twice daily
Interventions
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Placebo
Participants will receive placebo once daily
JNJ-54781532 25 mg once daily
Participants will receive 25 mg of JNJ-54781532 once daily
JNJ-54781532 75 mg once daily
Participants will receive 75 mg of JNJ-54781532 once daily
JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily
JNJ-54781532 75 mg twice daily
Participants will receive 75 mg of JNJ-54781532 twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
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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La Jolla, California, United States
Thornton, Colorado, United States
Ann Arbor, Michigan, United States
Tupelo, Mississippi, United States
Egg Harbor, New Jersey, United States
Salisbury, North Carolina, United States
Cleveland, Ohio, United States
Lima, Ohio, United States
Norman, Oklahoma, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Bankstown, , Australia
Bedford, , Australia
Concord, , Australia
Herston, , Australia
Launceston, , Australia
Melbourne, , Australia
Penrith, , Australia
South Brisbane, , Australia
Brussels, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Pleven, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Lille, , France
Paris, , France
Pessac, , France
Berlin, , Germany
Essen, , Germany
Frankfurt A. M., , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
Jena, , Germany
Kiel, , Germany
Magdeburg, , Germany
Münster, , Germany
Neustadt, , Germany
Stade, , Germany
Békéscsaba, , Hungary
Budapest, , Hungary
Mosonmagyaróvár, , Hungary
Szekszárd, , Hungary
Hadera, , Israel
Haifa, , Israel
Jerusalem, , Israel
Nazareth, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Amsterdam, , Netherlands
Amsterdam-Zuidoost, , Netherlands
Maastricht, , Netherlands
Rotterdam, , Netherlands
Elblag, , Poland
Lodz, , Poland
Sopot, , Poland
Warsaw, , Poland
Bucharest, , Romania
Constanța, , Romania
Iași, , Romania
Timișoara, , Romania
Kazan’, , Russia
Nizny Novgorod, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Rostov-on-Don, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Stavropol, , Russia
Ufa, , Russia
Yaroslavl, , Russia
Donetsk, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhia, , Ukraine
Zhaporozhia 69104, , Ukraine
Countries
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References
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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.
Sands 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.
Related Links
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Other Identifiers
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54781532UCO2001
Identifier Type: OTHER
Identifier Source: secondary_id
2013-000263-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR102640
Identifier Type: -
Identifier Source: org_study_id
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