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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 : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date July 25, 2022
Actual Study Start Date  ICMJE August 22, 2018
Estimated Primary Completion Date June 26, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • Proportion of subjects with a CDAI score of < 150 [ Time Frame: Approximately every 12 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Proportion of subjects with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
  • Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
  • 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 ]
  • Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to 234 Weeks ]
  • Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to 234 Weeks ]
  • Proportion of participants with CDAI reduction from baseline of ≥ 70 points [ Time Frame: Up to 234 Weeks ]
  • Change from baseline in CDAI [ Time Frame: Up to 234 Weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Proportion of participants with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to 234 Weeks ]
  • Proportion of participants with a CDAI score < 150 in participants off corticosteroids [ Time Frame: Up to 234 Weeks ]
  • Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to 234 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2018)
  • Proportion of subjects with average daily abdominal pain score ≤ 1 point, average daily stool frequency score ≤ 3, and stool frequency no worse than baseline. [ Time Frame: Up to approximately 48 weeks ]
    Abdominal pain scores and stool frequency scores are patient reported outcomes collected from the patient diary.
  • Proportion of subjects with Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of < 150 [ Time Frame: Up to approximately 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% [ Time Frame: Up to approximately 48 weeks ]
    Ulcer size will be measured during endoscopy, and assesses the degree of endoscopic inflammation.
  • Proportion of subjects with Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 70 points [ Time Frame: Up to approximately 48 weeks ]
    The CDAI is a composite score that is used to measure the clinical activity of CD.
  • Change from baseline in CDAI [ Time Frame: Up to approximately 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Proportion of subjects 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 approximately 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD. The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.
  • Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points [ Time Frame: Up to approximately 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD and the SES-CD assesses the degree of endoscopic inflammation.
  • Proportion of subjects with average SES-CD ≤ 4 points [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.
  • Proportion of subjects with SES-CD decrease ≥ 2 points [ Time Frame: Up to approximately 48 weeks ]
    The simple endoscopy score (SES-CD) assesses the degree of endoscopic inflammation.
  • Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids [ Time Frame: Up to approximately every 48 weeks ]
    The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD.
  • Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% [ Time Frame: Up to approximately 48 weeks ]
    CDEIS (Crohn's Disease Endoscopic Index of Severity) is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS score considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score can be calculated even in case of incomplete investigations, as the results of the individual segments are divided by the number of segments investigated. The presence of stenosis, as a result of ulcer or not, increases the score at the end of the computation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Official Title  ICMJE A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
Brief Summary This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE Drug: Ozanimod
Specified dose on specified days
Study Arms  ICMJE Experimental: Administration of oral Ozanimod
Intervention: Drug: Ozanimod
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2018)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2026
Estimated Primary Completion Date June 26, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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 #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   China,   Croatia,   Czechia,   Denmark,   Finland,   France,   Georgia,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Moldova, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT03467958
Other Study ID Numbers  ICMJE RPC01-3204
U1111-1203-8203 ( Registry Identifier: WHO )
2017-004295-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Celgene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Celgene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Celgene
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP