Purpose

This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.

Condition

Eligibility

Eligible Ages
Between 12 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and have completed the Week 12 efficacy assessments of the Induction Study.

2. Subject is in clinical response (a reduction from baseline in Crohn's Disease Activity Index (CDAI) of ≥ 100 points or CDAI score of < 150 points) and/or clinical remission (CDAI score of < 150 points) and/or has an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study.

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

Exclusions Related to General Health:

1. Subject has undergone a colectomy (partial or total), small bowel resection, or an ostomy (ie, temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Day 1 of the Induction Studies or has developed symptomatic fistula (enterocutaneous or entero-enteral).

Exclusions Related to Medications:

2. Subject has received any of the following therapies during the Induction Study:

a. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via foam or enema) b. post-baseline initiation of, or increase in, corticosteroids to treat worsening CD to a dose greater than the maximum daily dose taken between the screening and baseline visits c. rectal 5-ASA (ie, 5-ASA steroids administered to the rectum) d. parenteral corticosteroids e. total parenteral nutrition therapy f. antibiotics for the treatment of CD g. immunomodulatory agents (6-MP, azathioprine, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus) h. immunomodulatory biologic agents as well as other treatments for CD such asetrasimod, filgotinib, and upadacitinib I. investigational agents j. apheresis

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of oral Ozanimod 0.92mg
Subjects will receive a single 0.92 mg capsule [equivalent to ozanimod HCl 1 mg] once daily x 52 weeks
  • Drug: Ozanimod
    Ozanimod
Placebo Comparator
Administration of Placebo
Subjects will receive placebo capsule orally once daily x 52 weeks
  • Other: Placebo
    Placebo
Experimental
Administration of oral Ozanimod 0.46mg
Subjects will receive a single 0.46 mg capsule [equivalent to ozanimod HCl .5 mg] once daily x 52 weeks
  • Drug: Ozanimod
    Ozanimod

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

Associate Director Clinical Trial Disclosure
1-888-260-1599
clinicaltrialdisclosure@celgene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.