A PHASE 3, MULTI CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS MAINTENANCE THERAPY FOR MODERATELY TO SEVERLY ACTIVE CROHN's DISEASE
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.
18 Years to 75 Years
Accepting Healthy Volunteers?
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) or in clinical remission based on an average stool frequency score ≤ 3 with a stool frequency no worse than baseline and an average abdominal pain score ≤ 1 or CDAI score of < 150 points at Week 12 of the Induction Study.
The presence of any of the following will exclude a subject from enrollment:
Exclusions Related to General Health:
1. 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.
2. Subject is pregnant, lactating, or has a positive urine beta human chorionic gonadotropin (β-hCG) measured prior to randomization.
3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated.
4. Subject has a history of uveitis (within the last year) or clinically confirmed diagnosis of macular edema.
5. 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).
6. Subject has had active 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:
7. Subject has received any of the following therapies during the Induction Study:
1. rectal steroid therapy (ie, steroids administered to the rectum or sigmoid via foam or enema)
2. rectal 5-ASA (ie, 5-ASA steroids administered to the rectum)
3. parenteral corticosteroids
4. total parenteral nutrition therapy
5. antibiotics for the treatment of CD
6. immunomodulatory agents (6-MP, azathioprine, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
7. immunomodulatory biologic agents
8. investigational agents
8. Subject has current or planned treatment with immunomodulatory agents (eg, azathioprine, 6-MP, or methotrexate) during the Maintenance Study.
9. Subject has chronic nonsteroidal anti-inflammatory drug (NSAID) use (note: occasional use of NSAIDs and acetaminophen [eg, headache, arthritis, myalgias, or menstrual cramps] and aspirin up to 325 mg/day is permitted).
10. 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.
11. Subject has received a live vaccine within 4 weeks prior to first dose of IP.
12. Subject has received previous treatment with lymphocyte-depleting therapies (eg, Campath™, anti-CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, or daclizumab).
13. Subject has received previous treatment with D-penicillamine, leflunomide or thalidomide.
14. Subject has received previous treatment with natalizumab or fingolimod.
15. Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 16 weeks of first dose of IP.
16. Subject has a history of treatment with IV immune globulin (IVIg), or plasmapheresis, within 3 months prior to first dose of IP.
Exclusions Related to Laboratory Results:
17. Subject has ECG results showing any clinically significant abnormality at Week 12 of the Induction Study.
18. Subject has confirmed aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the ULN
19. Subject has a forced expiratory volume at 1 second (FEV1) or forced vital capacity (FVC) < 50% of predicted values prior to randomization.
20. Subject has confirmed absolute lymphocyte count (ALC) < 200 cells/μL