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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01959282




Registration number
NCT01959282
Ethics application status
Date submitted
7/10/2013
Date registered
10/10/2013
Date last updated
4/01/2019

Titles & IDs
Public title
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
Scientific title
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
Secondary ID [1] 0 0
54781532UCO2001
Secondary ID [2] 0 0
CR102640
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - JNJ-54781532 25 mg once daily
Treatment: Drugs - JNJ-54781532 75 mg once daily
Treatment: Drugs - JNJ-54781532 150 mg once daily
Treatment: Drugs - JNJ-54781532 75 mg twice daily

Placebo comparator: 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

Experimental: 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

Experimental: 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

Experimental: 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

Experimental: 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


Treatment: Drugs: Placebo
Participants will receive placebo once daily

Treatment: Drugs: JNJ-54781532 25 mg once daily
Participants will receive 25 mg of JNJ-54781532 once daily

Treatment: Drugs: JNJ-54781532 75 mg once daily
Participants will receive 75 mg of JNJ-54781532 once daily

Treatment: Drugs: JNJ-54781532 150 mg once daily
Participants will receive 150 mg of JNJ-54781532 once daily

Treatment: Drugs: JNJ-54781532 75 mg twice daily
Participants will receive 75 mg of JNJ-54781532 twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the Mayo score at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Number of participants with clinical response at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Number of participants with clinical remission at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Number of participants with mucosal healing at Week 8
Timepoint [3] 0 0
Week 8

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/12/2015
Sample size
Target
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bankstown
Recruitment hospital [2] 0 0
- Bedford
Recruitment hospital [3] 0 0
- Concord
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
- Launceston
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Penrith
Recruitment hospital [8] 0 0
- South Brisbane
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment postcode(s) [2] 0 0
- Bedford
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Launceston
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Penrith
Recruitment postcode(s) [8] 0 0
- South Brisbane
Recruitment outside Australia
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United States of America
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California
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Colorado
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Michigan
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Mississippi
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New Jersey
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Virginia
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Washington
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Belgium
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Brussel
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Varna
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Canada
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Alberta
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British Columbia
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Canada
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Manitoba
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Ontario
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Quebec
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France
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Lille Cedex
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France
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Paris
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France
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Pessac
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Germany
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Berlin
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Essen
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Frankfurt A. M.
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Hannover
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Heidelberg
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Herne
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Jena
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Germany
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Kiel
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Magdeburg
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Münster
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Germany
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Neustadt
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Germany
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Stade
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Hungary
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Budapest N/A
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Hungary
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Budapest
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Hungary
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Békéscsaba
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Hungary
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Mosonmagyarovar
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Hungary
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Szekszárd
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nazareth
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Israel
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Ramat Gan
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Israel
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Rechovot
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Netherlands
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Amsterdam Zuidoost
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Amsterdam
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Maastricht
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Netherlands
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Rotterdam
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Poland
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Elblag
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Lodz
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Sopot
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Warszawa
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Romania
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Bucharest
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Bucuresti
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Romania
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Constanta
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Iasi
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Romania
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Timisoara
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Russian Federation
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Kazan N/A
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Russian Federation
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Nizny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Omsk
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Russian Federation
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Rostov-On-Don
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Russian Federation
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Ryazan
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Saint Petersburg
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St Petersburg
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St-Petersburg
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Russian Federation
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Stavropol
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Ufa
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Yaroslavl
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Ukraine
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Donetsk
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Ivano-Frankovsk
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Kharkiv
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Kiev
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Kiiev
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Kyiv
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Lviv
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Ukraine
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Odessa
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Ukraine
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Ternopil
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Ukraine
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Uzhgorod
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Ukraine
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Vinnitsa
Country [87] 0 0
Ukraine
State/province [87] 0 0
Zaporizhzhia
Country [88] 0 0
Ukraine
State/province [88] 0 0
Zhaporozhia 69104

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01959282
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01959282