This trial is active, not recruiting.

Condition ulcerative colitis
Treatments rpc1063, placebo
Phase phase 2
Sponsor Celgene
Start date December 2012
End date October 2014
Trial size 199 participants
Trial identifier NCT01647516, RPC01-202


The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
oral, low dose, daily for 32 weeks
oral, high dose, daily for 32 weeks
(Placebo Comparator)
oral, one capsule, daily for 32 weeks

Primary Outcomes

time frame: Week 8

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Ulcerative colitis (UC) confirmed on endoscopy - Moderately to severely active UC (Mayo score 6-12) Exclusion Criteria: - Current use of anti-TNF agents

Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Celgene.