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Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03440372
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ozanimod Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : June 27, 2023
Estimated Study Completion Date : September 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Administration of oral Ozanimod Drug: Ozanimod
Specified dose on specified days
Placebo Comparator: Administration of Placebo Other: Placebo
Specified dose on specified days


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

Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  3. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 [ Time Frame: Week 12 ]
  4. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  5. Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]
  6. 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 ]
  7. 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 ]
  8. Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes) [ Time Frame: Week 12 ]
  9. Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 12 ]
  10. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Week 12 ]
  11. Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 therapies
  • Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
  • An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
  • Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)

Exclusion Criteria:

  • Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
  • Has 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440372


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03440372    
Other Study ID Numbers: RPC01-3201
U1111-1203-7225 ( Registry Identifier: WHO )
2017-004292-31 ( EudraCT Number )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Crohn's Disease
Crohn Disease
Oral
Ozanimod
 Moderately active
Severely active
RPC01
RPC01-3201
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Ozanimod
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs