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Active (not recruiting) Phase 2 2025-521242-26-00

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

Phase 2 – studying effectiveness and dosage
Conditions: Moderately to Severely Active Ulcerative Colitis

Sponsor: Spyre Therapeutics Inc.

trial.available_in: БГ
Overview
Trial status: Authorised 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. Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12.
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.
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 238 participants
Interventions
SPYPBO-102
Drug
SPYPBO-101
Drug
SPY002
Drug
SPY002
Drug
SPY001-001
Drug
SPY001-001
Drug
Locations 16
Austria (1)
Belgium (1)
Bulgaria (1)
Croatia (1)
Czech Republic (1)
France (1)
Germany (1)
Greece (1)
Hungary (1)
Italy (1)
Lithuania (1)
Netherlands (1)
Poland (1)
Romania (1)
Slovakia (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.11.2025
Registry ID
2025-521242-26-00
Source
euclinicaltrials.eu
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