The trial is taking place at:
R

Research Associates of South Florida | Miami, FL

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

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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

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

Trial contacts and locations

415

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain the NCT# and Site #.

Data sourced from clinicaltrials.gov

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