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Активно (без набиране) Фаза 2 2025-522333-61-00

A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Hidradenitis suppurativa

Спонсор: Sanofi-Aventis Recherche & Developpement

Налично на: БГ
Обобщение
Trial status: Authorised Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody responses. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Описание
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody responses.
Кой може да участва
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 132 participants
Места на провеждане 9
Чехия (1)
Франция (1)
Германия (1)
Гърция (1)
Унгария (1)
Италия (1)
Нидерландия (1)
Полша (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
22.12.2025
Регистрационен номер
2025-522333-61-00
Източник
euclinicaltrials.eu
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