A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01959282
• Date of registration: 07/10/2013
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• 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
• Date of first enrolment: November 15, 2013
• Target sample size: 219
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01959282
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Russian Federation, Ukraine, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Placebo

Drug: JNJ-54781532 150 mg once daily

Drug: JNJ-54781532 75 mg once daily

Drug: JNJ-54781532 75 mg twice daily

Drug: JNJ-54781532 25 mg once daily

Primary Outcome(s)

Change from baseline in the Mayo score at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

Number of participants with clinical response at Week 8 [Time Frame: Week 8]

Number of participants with clinical remission at Week 8 [Time Frame: Week 8]

Number of participants with mucosal healing at Week 8 [Time Frame: Week 8]

Secondary ID(s)

2013-000263-88

54781532UCO2001

CR102640

Source(s) of Monetary Support

Please refer to primary and secondary sponsors