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A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03464097
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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.

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 : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : March 24, 2025
Estimated Study Completion Date : June 24, 2025

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: Ozanimod Drug: Ozanimod
Specified dose on specified days
Placebo Comparator: 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 of < 150 [ Time Frame: Weekk 52 ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD

  2. Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Week 52 ]
  2. Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stoolfrequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline [ Time Frame: Week 52 ]
  3. Proportion of participants with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks [ Time Frame: Week 52 ]
  4. Proportion of participants with a CDAI score of < 150 in participants with a CDAI score < 150 at pre-randomization [ Time Frame: Week 52 ]
  5. Proportion of participants with a CDAI score of < 150 at Week 52 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in participants with a CDAI score <150 at pre-randomization [ Time Frame: Week 52 ]
  6. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% at Week 52 [ Time Frame: Week 52 ]
  7. Histologic improvement based on differences between ozanimod and placebo in histologic diseaseactivity scores (ie, Global Histologic Disease Activity Score [GHAS] changes) [ Time Frame: Week 52 ]
  8. Proportion of participants with average daily abdominal pain score ≤ 1 point, with average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 52 ]
  9. Proportion of participants with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Week 52 ]
  10. Proportion of participants with average daily abdominal pain score ≤ 1 point, with average daily stoolfrequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD ≤ 4 points and a SES-CD decrease ≥2 points [ Time Frame: Week 52 ]
  11. 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 52 ]
  12. Proportion of participants with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥50% [ Time Frame: Week 52 ]
  13. Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Week 52 ]
  14. Proportion of participants with mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points) with histologic improvement by GHAS or Robarts Histologic Index [ Time Frame: Week 52 ]
  15. Time to relapse and exclusion of other causes of an increase in disease activity unrelated tounderlying CD (eg, infections, change in medication) [ Time Frame: Week 52 ]
  16. Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Week 52 ]

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

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03464097


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: 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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03464097    
Other Study ID Numbers: RPC01-3203
U1111-1203-8002 ( Registry Identifier: WHO )
2017-004294-14 ( EudraCT Number )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023

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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
RPC01-3203
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