Phase 3 N=606 Randomized Quadruple-blind Treatment

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

Crohn Disease

Bottom Line

View on ClinicalTrials.gov: NCT03440385 ↗

Enrolled (actual)

606

Serious AEs

5.8%

Results posted

Dec 2024

Primary outcome: Primary: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 — 29.8; 30.5 percentage of participants — p=0.8125

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ozanimod (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Celgene
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150	29.8; 30.5	0.8125
SECONDARY Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission	29.0; 26.6	0.5400
SECONDARY Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	25.6; 21.2	0.2411
SECONDARY Percentage of Participants With Reduction From Baseline in the Crohn's Disease Activity Index (CDAI) Score of >= 100 Points or a Total CDAI Score < 150	46.2; 47.3	0.7469
SECONDARY Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score Reduction From Baseline of ≥ 100 Points or CDAI Score < 150 and SES-CD Decrease From Baseline of ≥ 50%	16.9; 14.3	0.4255
SECONDARY Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150 and Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline of ≥ 50%	11.7; 11.3	0.9313
SECONDARY Percentage of Participants With Abdominal Pain and Stool Frequency Clinical Remission and a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score <= 4 Points and Decrease >= 2 Points	10.4; 8.4	0.4339
SECONDARY Percentage of Participants With Global Histologic Activity Score (GHAS) Remission	13.6; 10.8	0.3330
SECONDARY Percentage of Participants With CDAI Reduction From Baseline of >=70 Points	52.9; 51.7	0.8200
SECONDARY Percentage of Participants With Absence of Ulcers ≥ 0.5 cm With no Segment With Any Ulcerated Surface ≥10%	25.3; 24.1	0.7776
SECONDARY Percentage of Participants With a Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of ≥ 50%	27.5; 21.7	0.1187
SECONDARY Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission and an Endoscopic (50%) Response	11.7; 9.4	0.4030
SECONDARY Percentage of Participants With Robarts Histologic Index (RHI) Mucosal Healing at Week 12	4.0; 4.9	0.5630

Summary

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03440385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.