Moderately to Severely Active Crohn’s Disease
Conditions
Brief summary
Primary efficacy: Proportion of participants with endoscopic response as determined using the Simple Endoscopic Score-CD (SES-CD) at Week 14.
Detailed description
Secondary efficacy: - Proportion of participants with clinical response as determined using the CDAI at Week 14; - Proportion of participants with clinical remission as determined using the CDAI at Week 14., Safety: Frequencies and proportions of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation. Change in laboratory parameters, vital signs, and ECG results.
Interventions
Sponsors
Morphic Therapeutic Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy: Proportion of participants with endoscopic response as determined using the Simple Endoscopic Score-CD (SES-CD) at Week 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy: - Proportion of participants with clinical response as determined using the CDAI at Week 14; - Proportion of participants with clinical remission as determined using the CDAI at Week 14., Safety: Frequencies and proportions of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation. Change in laboratory parameters, vital signs, and ECG results. | — |
Countries
Austria, Croatia, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Romania, Slovakia, Spain
Outcome results
None listed