Crohn's Disease
Conditions
Brief summary
SSA-P2:Proportion of subjects with endoscopic response, SS1-P2b:Proportion of subjects with endoscopic response at Week 14, SS2-I: • Proportion of subjects with endoscopic response at Week 14. • Proportion of subjects with clinical remission CDAI at Week 14, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 • Proportion of subjects with endoscopic response at Week 52
Detailed description
SSA-P2:• Proportion of subjects with clinical remission CDAI • Change from baseline in SES-CD score • Change from baseline in CDAI score. •Etrasimod plasma concentrations at 4 hours postdose and at steady-state trough concentrations at selected timepoints.• Change and percentage change from baseline in ALC., SS1-P2b:• Proportion of subjects with clinical remission CDAI at Week 14 • Proportion of subjects with clinical remission by PRO2 at Week 14, SS2-I:• Proportion of subjects with clinical remission PRO2 at Week 14 • Proportion of subjects with clinical response CDAI at Week 14 • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 • Proportion of subjects with endoscopic remission at Week 14 •, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M baseline, SS4-E:• Proportion of subjects with clinical remission CDAI by visit up to the end of treatment • Proportion of subjects with clinical remission PRO2 by visit up to the end of treatment
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SSA-P2:Proportion of subjects with endoscopic response, SS1-P2b:Proportion of subjects with endoscopic response at Week 14, SS2-I: • Proportion of subjects with endoscopic response at Week 14. • Proportion of subjects with clinical remission CDAI at Week 14, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 • Proportion of subjects with endoscopic response at Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| SSA-P2:• Proportion of subjects with clinical remission CDAI • Change from baseline in SES-CD score • Change from baseline in CDAI score. •Etrasimod plasma concentrations at 4 hours postdose and at steady-state trough concentrations at selected timepoints.• Change and percentage change from baseline in ALC., SS1-P2b:• Proportion of subjects with clinical remission CDAI at Week 14 • Proportion of subjects with clinical remission by PRO2 at Week 14, SS2-I:• Proportion of subjects with clinical remission PRO2 at Week 14 • Proportion of subjects with clinical response CDAI at Week 14 • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 • Proportion of subjects with endoscopic remission at Week 14 •, SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M base | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain