bowel disease immune-mediated inflammatory disease of the gastrointestinal tract
Conditions
Interventions
The possible treatments are as follows:
* ozanimod: taken by mouth as a single 0.92
mg capsule (equivalent to ozanimod
hydrochloride [HCl] 1 mg) once daily x 52
weeks, or
* placebo: taken by mouth as
Sponsors
Celgene International II Sàrl
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 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
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 antiarrhythmic drugs, 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 previo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: - Proportion of subjects with a CDAI score of = 50% at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Secondary Endpoints: - Proportion of subjects with CDAI reduction from baseline of >= 100 points or CDAI score of = 80% of visits between Week 8 and Week 52, inclusive, in subjects with a CDAI score = 0.5 cm with no segment with any ulcerated surface >= 10% at Week 52 - Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score [GHAS] changes (Geboes, 2000)) at Week 52 - Proportion of subjects with average daily abdominal pain score = 50% at Week 52 Additional Secondary Endpoints: - Proportion of subjects with CDAI score of = 50% at Week 52 - Proportion of subjects with average daily abdominal pain score =2 points at Week 52 - Proportion of subjects with CDAI reduction from baseline of >= 100 points or CDAI score = 50% at Week 52 - Proportion of subjects with CDAI score = 50% at Week 52 - Proportion of subjects with CDAI reduction from baseline of >= 70 points at Week 52 - Proportion of subjects with mucosal healing (SES-CD = 2 points) and histologic improvement by GHAS or Robarts Histologic Index (RHI) at Week 52 - Time to relapse (an increase in the CDAI score from Maintenance Day 1 of >= 100 points and a CDAI score > 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 | — |
Countries
Netherlands
Outcome results
None listed