Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease

Celgene

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: RPC1063

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531113

RPC01-2201

Details and patient eligibility

About

The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.

Full description

This open-label trial is composed of two periods: Induction and Extension. All eligible patients will be enrolled into the 12-Week Induction period and receive study medication. Patients who complete the Induction period may then be eligible to enter the 100-Week Extension period where they will continue to receive study medication.

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Crohn's disease (CD) confirmed by endoscopy and histology
• Active disease as evaluated by Crohn's Disease Activity Index Score and Simple Endoscopic Score for CD
• Inadequate response to aminosalicylates, corticosteroids, immunomodulators or biologic therapy

Key Exclusion Criteria:

• Diagnosis of ulcerative colitis or indeterminate colitis
• Known strictures/stenosis leading to symptoms of obstruction
• Current stoma or need for ileostomy or colostomy
• 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 known macular edema
• History of colonic dysplasia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

RPC1063 (Ozanimod)

Experimental group

Treatment:

Drug: RPC1063