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

Celgene

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: RPC1063; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02435992

RPC01-3101

Details and patient eligibility

About

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

Full description

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Enrollment: 1,012 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 75 years (at screening for Cohort 1 and 2)
• UC confirmed on endoscopy
• Moderately to severely active UC (May score 6-12)
• Currently receiving treatment with aminosalisylate, prednisone, or budesonide
• Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization

Exclusion criteria

• Have severe extensive colitis as evidence by:
• Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
• Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
• Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, 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 or unknown macular edema
• Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,012 participants in 2 patient groups, including a placebo group

RPC1063 (Ozanimod)

Experimental group

Description:

1mg, daily oral administration during Induction and Maintenance periods.

Treatment:

Drug: RPC1063

Placebo

Placebo Comparator group

Description:

Daily oral administration during Induction and Maintenance periods.

Treatment:

Drug: Placebo