Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03440385
• Date of registration: 14/02/2018
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
• Scientific title: Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
• Date of first enrolment: March 7, 2018
• Target sample size: 606
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03440385
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Israel, Korea, Republic of, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

Inclusion Criteria:

- Crohn's disease for = 3 months on endoscopy and on histological exam

- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or
biologic therapy

- Crohn's Disease Activity Index (CDAI) score = 220 and = 450

- Average daily stool frequency = 4 points and/or an abdominal pain of = 2 points

- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of = 6 (or SES-CD = 4 in
participants with isolated ileal disease)

Exclusion Criteria:

- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic
colitis, or has strictures with prestenotic dilatation requiring procedural
intervention

- Extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome,
or requires total parenteral nutrition

- Current stoma, ileal-anal pouch anastomosis, or fistula

Other protocol-defined inclusion/exclusion criteria apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Ozanimod

Other: Placebo

Primary Outcome(s)

Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 [Time Frame: Week 12]

Secondary Outcome(s)

Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of = 50% [Time Frame: Week 12]

Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD = 4 points and decrease =2 points [Time Frame: Week 12]

Proportion of participants with an average daily abdominal pain score = 1 point, and average daily stool frequency score = 3 points and both no worse than baseline AND an SES-CD decrease from baseline of = 50% [Time Frame: Week 12]

Histologic improvement based on differences between ozanimod and placebo in histologic disease activity scores using the Global Histologic Disease Activity Score [Time Frame: Week 12]

Proportion of participants with CDAI reduction from baseline of = 70 points [Time Frame: Week 12]

Proportion of participants with absence of ulcers = 0.5 cm with no segment with any ulcerated surface = 10% [Time Frame: Week 12]

Proportion of participants with CDAI score < 150 with SES-CD decrease from baseline of = 50% [Time Frame: Week 12]

Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of = 50% [Time Frame: Week 12]

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 with SES-CD decrease from baseline of = 50% [Time Frame: Week 12]

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 [Time Frame: Week 12]

Proportion of participants with CDAI reduction from baseline of = 100 points or CDAI score < 150 [Time Frame: Week 12]

Secondary ID(s)

U1111-1203-7949

2017-004293-33

RPC01-3202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors