Moderately to Severely Active Crohn's Disease
Conditions
Brief summary
Proportion of subjects with a CDAI score of < 150, Proportion of subjects with a SES-CD decrease from baseline of ≥ 50%, Proportion of subjects 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, Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150, Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%, Proportion of subjects with CDAI reduction from baseline of ≥ 70 points, Change from baseline in CDAI, Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50%, Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES CD decrease ≥ 2 points, Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points and a stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points, Proportion of subjects with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points, Proportion of subjects with a CDAI score < 150 in subjects off corticosteroids, Proportion of subjects with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50%, Proportion of subjects with average daily abdominal pain score ≤ 1 point, average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline, and SES-CD decrease from baseline ≥ 50%, Efficacy in subjects (clinical response, clinical remission, and endoscopic improvement) as a function of baseline and change- from baseline in biomarkers (eg, C-reactive protein, fecal calprotectin, high-density lipoprotein, IgA, IL-7), To assess impact of SARS-CoV-2 serologic status on subjects receiving ozanimod and CD, Exploratory measurements of SARS-CoV-2 serology (anti-SARS-CoV-2 total or IgG), from serum samples collected every 48 weeks.
Detailed description
Not applicable
Interventions
DRUGOzanimod
Sponsors
Celgene International II SARL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a CDAI score of < 150, Proportion of subjects with a SES-CD decrease from baseline of ≥ 50%, Proportion of subjects 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, Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150, Proportion of subjects with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10%, Proportion of subjects with CDAI reduction from baseline of ≥ 70 points, Change from baseline in CDAI, Proportion of subjects with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50%, Proportion of subjects with CDAI score of < 150 and SES-CD ≤ 4 points and a SES CD decrease ≥ 2 points, Proportion of subjects with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points and a stool frequency no wors | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable | — |
Countries
Bulgaria, Croatia, Czechia, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Spain
Outcome results
None listed