A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03464097
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Celgene
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jerry Liu, MD
Principal Investigator Affiliation	Celgene Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Crohn Disease
Study Website:	View Trial Website

Arms & Interventions

Arms

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

Placebo Comparator: Administration of Placebo

Subjects will receive placebo capsule orally once daily x 52 weeks

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

Interventions

Drug: - Ozanimod

Ozanimod

Other: - Placebo

Placebo

Contact a Trial Team

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Holland Center for Family Health, Peoria, Arizona

Status

Completed

Address

Holland Center for Family Health

Peoria, Arizona, 85381

Site Contact

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