A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
- Registration Number
- NCT03464097
- Lead Sponsor
- Celgene
- Brief Summary
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 551
- Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- In clinical response and/or clinical remission and/or 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
- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ozanimod Ozanimod - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of participants with Crohn's Disease Activity Index (CDAI) score < 150 Week 52 The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD
Proportion of participants with Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline ≥ 50% Week 52
- Secondary Outcome Measures
Name Time Method Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline ≥ 50% Week 52 Proportion of participants with CDAI score < 150 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in participants with CDAI score < 150 at Maintenance Day 1 Week 52 Proportion of participants with CDAI reduction from baseline ≥ 100 points or CDAI score < 150 Week 52 Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline Week 52 Proportion of participants with CDAI score < 150 at Week 52, while remaining corticosteroid-free in the 12 weeks prior to Week 52 among all participants at Maintenance Day 1 Week 52 Proportion of participants with CDAI score < 150 in participants with CDAI score < 150 at Maintenance Day 1 Week 52 Proportion of participants with Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 points and SES-CD decrease from baseline ≥ 2 points with no SES-CD subscore > 1 point Week 52 Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline ≥ 50% Week 52 Proportion of participants with ADAPS ≤1 point, and average daily stool frequency score ≤3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤4 points and SES-CD decrease ≥2 points with no SES-CD subscore >1 point Week 52 ADAPS is average daily abdominal pain score
Proportion of participants with CDAI reduction from baseline ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline ≥ 50% Week 52 Proportion of participants with CDAI score < 150 at Maintenance Day 1 and SES-CD decrease from baseline ≥50% Week 52 Proportion of participants with CDAI reduction from baseline ≥ 70 points Week 52 Proportion of participants with CDAI score < 150, while remaining corticosteroid free in the 12 weeks prior to Week 52 among participants using corticosteroids at Maintenance Day 1 Week 52 Proportion of participants with mucosal healing (SES-CD ≤ 4 points and SES-CD decrease ≥ 2 points with no SES-CD subscore > 1 point) and histologic improvement based on Robarts Histologic Index Week 52 Time to relapse (an increase in CDAI score from Maintenance Day 1 ≥100 points and CDAI score >220, SES-CD ≥6 [or ≥4 if isolated ileal disease]), and exclusion of other causes of an increase in disease activity unrelated to underlying CD Week 52 Crohn's Disease \[CD (eg, infections, change in medication)\]
Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD decrease from baseline ≥ 50% Week 52
Trial Locations
- Locations (762)
Local Institution - 141
🇺🇸Middleburg Heights, Ohio, United States
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Local Institution - 202
🇺🇸Scottsdale, Arizona, United States
Local Institution - 026
🇺🇸North Little Rock, Arkansas, United States
Local Institution - 284
🇺🇸Camarillo, California, United States
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Local Institution - 039
🇺🇸Garden Grove, California, United States
Ucsd Medical Center
🇺🇸La Jolla, California, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Local Institution - 010
🇺🇸Lancaster, California, United States
Scroll for more (752 remaining)Local Institution - 141🇺🇸Middleburg Heights, Ohio, United States