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An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

NCT02531126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 877

Last updated 2025-12-31

Study results available
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Summary

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Conditions

Interventions

DRUG

RPC1063

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-02
Primary Completion
2024-12-19
Completion
2024-12-19

Countries

  • United States
  • Australia
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Moldova
  • Poland
  • Romania
  • Slovakia
  • South Korea
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531126 on ClinicalTrials.gov