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

Phase 3

Terminated

Conditions: Crohn Disease

Interventions: Drug: Ozanimod

Registration Number: NCT03467958

Lead Sponsor: Celgene

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 available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 854

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: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of oral Ozanimod	Ozanimod	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Remission	At weeks 48, 96, 144, 192, 240	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From first dose to 90 days post last dose (up to approximately an average of 19 months and a maximum of 65 months)	A treatment-emergent adverse event (TEAE) is any AE that emerges or worsens between the day of the first dose of Open-label Extension Study and 90 days after the last dose of Open-label Extension Study. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Abdominal Pain (AP) and Stool Frequency (SF) Clinical Remission	At weeks 48, 96, 144, 192, 240	Abdominal pain (AP) and stool frequency (SF) clinical remission was defined as average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with AP and SF no worse than baseline. Participants entered responses in diaries daily. The 7 days entries prior to visit were considered for calculating average AP score and SF. The AP was graded on severity of 0 (none) to 3 (severe) scale and SF was defined number of liquid or soft stools per day. Higher scores indicated worse outcomes.
Percentage of Participants With Clinical Response	At weeks 48, 96, 144, 192, 240	Clinical response is defined as a Crohn's Disease Activity Index (CDAI) reduction from baseline of ≥ 100 points or CDAI score of \< 150. The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \\\[none\\\] to 3 \\\[Severe\\\]), general well-being (0 \\\[well\\\] to 4 \\\[terrible\\\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

Trial Locations

Locations (763): Holland Center for Family Health
🇺🇸
Peoria, Arizona, United States
Local Institution - 202
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Scottsdale, Arizona, United States
Local Institution - 026
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North Little Rock, Arkansas, United States
Local Institution - 284
🇺🇸
Camarillo, California, United States
Sharp Chula Vista Medical Center
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Chula Vista, California, United States
Local Institution - 039
🇺🇸
Garden Grove, California, United States
Ucsd Medical Center
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La Jolla, California, United States
San Diego Clinical Trials
🇺🇸
La Mesa, California, United States
Local Institution - 010
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Lancaster, California, United States
Local Institution - 061
🇺🇸
Los Angeles, California, United States
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Holland Center for Family Health
🇺🇸Peoria, Arizona, United States