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An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03467958
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : September 27, 2029
Estimated Study Completion Date : December 27, 2029

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with a CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinicalactivity of CD


Secondary Outcome Measures :
  1. Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
  2. 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 [ Time Frame: Up to 234 Weeks ]
  3. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
  4. Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to 234 Weeks ]
  5. Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Up to 234 Weeks ]
  6. Change from baseline in CDAI [ Time Frame: Up to 234 Weeks ]
  7. Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
  8. Proportion of participants with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
  9. 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 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
  10. Proportion of participants with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
  11. Proportion of participants with a CDAI score < 150 in participants off corticosteroids [ Time Frame: Up to 234 Weeks ]
  12. Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]

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:

  • Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
  • Experience relapse or who complete the Maintenance Study
  • Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion Criteria:

  • Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
  • Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
  • Is receiving treatment with any of the following drugs or interventions within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors

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): NCT03467958


Contacts
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Contact: Recruiting sites have contact information. Please contact the site 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: NCT03467958    
Other Study ID Numbers: RPC01-3204
U1111-1203-8203 ( Registry Identifier: WHO )
2017-004295-55 ( EudraCT Number )
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 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
RPC01-3204
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