Moderately to Severely Active Ulcerative Colitis
Conditions
Brief summary
Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12.
Detailed description
Part A: 1. Clinical remission at Week 12., Part A: 2. Endoscopic improvement at Week 12., Part A: 3. Change in modified Mayo score from baseline at Week 12., Part A: 4. Study drug concentration through Week 12., Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12., Part B: 1. Endoscopic improvement at Week 12., Part B: 2. Clinical response at Week 12., Part B: 3. Histologic improvement at Week 12., Part B: 4. HEMI at Week 12., Part B: 5. Clinical remission at Week 48., Part B: 6. Study drug concentration through Week 12., Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12.
Interventions
Sponsors
Spyre Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: 1. Clinical remission at Week 12., Part A: 2. Endoscopic improvement at Week 12., Part A: 3. Change in modified Mayo score from baseline at Week 12., Part A: 4. Study drug concentration through Week 12., Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12., Part B: 1. Endoscopic improvement at Week 12., Part B: 2. Clinical response at Week 12., Part B: 3. Histologic improvement at Week 12., Part B: 4. HEMI at Week 12., Part B: 5. Clinical remission at Week 48., Part B: 6. Study drug concentration through Week 12., Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12. | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain
Outcome results
None listed