Ensayos clínicos

Inclusion Criteria:

• Subject fulfilled the inclusion criteria at time of entry into the Induction Study (RPC01-3201 or RPC01-3202) and has completed the Week 12 efficacy assessments of the Induction Study
• Female subjects of childbearing potential 
• Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. 

Exclusion Criteria:

Exclusions Related to General Health

• Subject has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
• Subject is pregnant, lactating, or has a positive urine beta human chorionic gonadotropin (β-hCG) measured prior to randomization.
• Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
• Subject has undergone a colectomy (partial or total), small bowel resection, or an ostomy (i.e., temporary colostomy, permanent colostomy, ileostomy, or other enterostomy) since Day 1 of the Induction Studies or has developed symptomatic fistula (enterocutaneous or entero-enteral).
• Subject has had cancer within 5 years including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that have been excised and resolved); or colonic dysplasia that has not been completely removed.

Exclusions Related to Medications

• Hypersensitivity to active ingredients or excipients of ozanimod or placebo
• Subject has received any of the following therapies during the Induction Study
  • rectal steroid therapy
  • 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;
  • rectal 5- aminosalicylates (ASA)
  • parenteral corticosteroids;
  • total parenteral nutrition therapy
  • antibiotics for the treatment of CD
  • immunomodulatory agents
  • immunomodulatory biologic agents as well as other treatments for CD such as etrasimod, filgotinib, and upadacitinib
  • investigational agents
  • apheresis
• Subject has current or planned treatment with immunomodulatory agents during the Maintenance Study
• Subject has chronic nonsteroidal anti-inflammatory drug
• Subject has received treatment with Class Ia or Class III anti-arrhythmic drugs or treatment with 2 or more agents in combination known to prolong PR interval
• Subject has received a live or live attenuated vaccine within 4 weeks prior to first dose of IP
• Subject has received previous treatment with lymphocyte-depleting therapies
• Subject has received previous treatment with D-penicillamine, leflunomide or thalidomide
• Subject has received previous treatment with natalizumab, fingolimod, or other S1P modulators
• Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of first dose of IP
• Subject has a history of treatment with intravenous immunoglobulin (IVIg) or plasmapheresis, within 3 months prior to first dose of IP
• Subject is receiving treatment with breast cancer resistance protein (BCRP) inhibitors