Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

  • Interventional
  • Not Recruiting
  • NCT02435992
Eligibility Details Visit Clinicaltrials.gov

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

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

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in clinical response at the end of the Induction Period will proceed through to the Maintenance Period. Participation in these periods will be 52 weeks. Patients may also qualify to participate in an optional Open-Label Extension study.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Ulcerative Colitis (UC) confirmed on endoscopy

         - Moderately to severely active UC (Mayo score 6-12)

         - Currently receiving treatment with aminosalisylate, prednisone, or budesonide

        Key Exclusion Criteria:

         - Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis

         - Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk

         - History of uveitis macular edema

         - Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during Screening

At a Glance

National Government IDNCT02435992

IRB#IRB15-0673

Lead SponsorCelgene

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Not Recruiting