Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Celgene International II Sàrl
Eligibility
Sex/Gender
All
Inclusion 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 has completed the Week 12 efficacy assessments of the Induction Study. 2. Subject should not have any constraints under local regulations, must provide written informed consent prior to any study-related procedures, and must have the ability to comply with the Table of Events. 3. Subject is in clinical response (a reduction from baseline in CDAI of = 100 points or CDAI score of =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Exclusions Related to General Health: 1. Subject has any clinically relevant cardiovascular, hepatic, neurological, pulmonary (severe respiratory disease [pulmonary fibrosis or chronic obstructive pulmonary disease]), 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 (ß-hCG) test measured prior to randomization. 3. Subject has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated. 4. 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). 5. 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: 6. Hypersensitivity to active ingredients or excipients of ozanimod or placebo 7. 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 (of induction) 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- aminosalicylates (ASA) (ie, 5-ASA administered to the rectum) d. parenteral corticosteroids > 14 days e. total parenteral nutrition therapy f. antibiotics for the treatment of CD g. immunomodulatory agents (6-MP, AZA, including but not limited to cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus) h. immunomodulatory biologic agents as well as other treatments for CD such as etrasimod, filgotinib, and upadacitinib i. investigational agents j. apheresis 8. Subject has current or planned treatment with immunomodulatory agents (eg, AZA, 6-MP, or MTX) 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 or treatment with additional prohibited systemic cardiac medication provided in Table 7. 11. Subject has received a live or live attenuated 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, fingolimod, or other S1P modulators. 15. Subject has received previous treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofeti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the efficacy of ozanimod compared to placebo on the maintenance of clinical remission and endoscopic response;Secondary Objective: -Demonstrate the efficacy of ozanimod compared to placebo on maintenance of clinical response - Demonstrate the efficacy of ozanimod compared to placebo on maintenance of endoscopic remission and mucosal healing - Demonstrate the efficacy of ozanimod, compared to placebo, in achieving corticosteroid-free remission - Characterize the population pharmacokinetics (PK) and PK/pharmacodynamics (PD) relationship of ozanimod - Demonstrate the efficacy of ozanimod, compared to placebo, on healthcare resource utilization (HRU), subject-reported outcomes, and quality of life - Demonstrate the safety and tolerability of ozanimod as maintenance therapy ;Primary end point(s): - Proportion of subjects with a CDAI score of < 150 at Week 52 - Proportion of subjects with a Simple Endoscopic Score for Crohn’s Disease (SESCD) decrease from baseline of = 50% at Week 52;Timepoint(s) of evaluation of this end point: - The first primary endpoint is CDAI clinical remission at Week 52. Subjects will be deemed responders with respect to this endpoint if they meet the definition, CDAI score of < 150 at Week 52. - The second primary endpoint is endoscopic response (50%) at Week 52. Subjects will be deemed responders with respect to this endpoint if they meet the definition, SES-CD decrease from baseline of = 50% at Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Major Secondary Endpoints: - Proportion of subjects with CDAI reduction from baseline of = 100 points or CDAI score of 220, SES-CD score = 6 [or = 4 if isolated ileal disease]), and exclusion of other causes of an increase in disease activity unrelated to underlying CD (eg, infections, change in medication) - Proportion of subjects with a Crohn’s Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% at Week 52 ;Timepoint(s) of evaluation of this end point: at Week 52 | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Meyers Squibb International Corporation
Outcome results
None listed