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Активно (без набиране) Фаза 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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Moderately to Severely Active Ulcerative Colitis

Спонсор: Spyre Therapeutics Inc.

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 238 participants
Интервенции
SPYPBO-102
Drug
SPYPBO-101
Drug
SPY002
Drug
SPY002
Drug
SPY001-001
Drug
SPY001-001
Drug
Места на провеждане 16
Австрия (1)
Белгия (1)
България (1)
Хърватия (1)
Чехия (1)
Франция (1)
Германия (1)
Гърция (1)
Унгария (1)
Италия (1)
Lithuania (1)
Нидерландия (1)
Полша (1)
Румъния (1)
Словакия (1)
Испания (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
10.11.2025
Регистрационен номер
2025-521242-26-00
Източник
euclinicaltrials.eu
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