Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Celgene

Status and phase: Active, not recruiting; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Ozanimod; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03440372

2017-004292-31 (EudraCT Number)

RPC01-3201

U1111-1203-7225 (Registry Identifier)

Details and patient eligibility

About

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Crohn's disease for ≥ 3 months on endoscopy and on histological exam
• Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
• Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
• An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
• Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion criteria

• Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
• Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
• Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Administration of oral Ozanimod

Experimental group

Treatment:

Drug: Ozanimod

Administration of Placebo

Placebo Comparator group

Treatment:

Other: Placebo