NCT01959282

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Detailed description

This is a Phase 2b, multicenter, randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), parallel-group (each group of participants will be treated at the same time), dose-response study (a study to evaluate response to different dosages of study medication) of oral tablets of JNJ-54781532 in adult participants with moderately to severely active UC. Approximately 220 participants will be randomized in a 1:1:1:1:1 ratio to 1 of 5 treatment groups at Week 0 (placebo; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 150 mg once daily; and JNJ-54781532 75 mg twice daily) to receive their randomized dosage of study medication through Week 8 and will be assessed for clinical response at Week 8. Participants who achieve clinical response at Week 8 will continue to receive their original randomized dosage of study medication through Week 32. Participants who do not achieve clinical response at Week 8 will be treated as follows: participants originally randomized to placebo will receive JNJ-54781532 150 mg once daily through Week 16; participants originally randomized to JNJ-54781532 will continue to receive their original randomized dosage of JNJ-54781532 through Week 16. Participants who were not in clinical response at Week 8 and do not achieve a partial Mayo score response (a decrease from baseline in the partial Mayo score by ≥3 points) at Week 16 will be discontinued from study medication; and those who achieve a partial Mayo score response at Week 16 can continue receiving JNJ 54781532 through Week 32. Participants will be evaluated for safety (adverse events) up to Week 36 (ie, 4 weeks after the last dose of study medication). The maximum study duration for each participant will be approximately 44 weeks (including maximum screening period).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Placebo	Participants will receive placebo once daily
DRUG	JNJ-54781532 25 mg once daily	Participants will receive 25 mg of JNJ-54781532 once daily
DRUG	JNJ-54781532 75 mg once daily	Participants will receive 75 mg of JNJ-54781532 once daily
DRUG	JNJ-54781532 150 mg once daily	Participants will receive 150 mg of JNJ-54781532 once daily
DRUG	JNJ-54781532 75 mg twice daily	Participants will receive 75 mg of JNJ-54781532 twice daily

Timeline

• Start date: 2013-11-15
• Primary completion: 2015-05-20
• Completion: 2015-12-05
• First posted: 2013-10-10
• Last updated: 2019-01-04

Locations

97 sites across 14 countries: United States, Australia, Belgium, Bulgaria, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Romania, Russia, Ukraine

Regulatory

• FDA-regulated drug study