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Активно (без набиране) Фаза 3 2024-514737-37-00

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults

Фаза 3 – широко изпитване преди одобрение
Заболявания: Neurodermatitis

Спонсор: Sanofi-Aventis Recherche & Developpement

Налично на: БГ
Обобщение
Trial status: Authorised Absolute change in weekly average of daily WI-NRS from baseline to Week 24, Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Absolute change in ItchyQoL score from baseline to Week 24, Absolute change in DLQI total score from baseline to Week 24, Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12, Incidence of treatment-emergent ADA against dupilumab, Percentage of participants experiencing TEAEs or SAEs from baseline through Week 24, Percentage change in weekly average of daily WI-NRS from baseline to Week 24, Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24, Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24 Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Описание
Absolute change in weekly average of daily WI-NRS from baseline to Week 24, Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Absolute change in ItchyQoL score from baseline to Week 24, Absolute change in DLQI total score from baseline to Week 24, Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12, Incidence of treatment-emergent ADA against dupilumab, Percentage of participants experiencing TEAEs or SAEs from baseline through Week 24, Percentage change in weekly average of daily WI-NRS from baseline to Week 24, Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24, Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24, Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 77 participants
Интервенции
Dupilumab
Drug
Matched placebo for test product
Drug
Места на провеждане 8
Белгия (1)
Чехия (1)
Германия (1)
Гърция (1)
Унгария (1)
Италия (1)
Португалия (1)
Испания (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
04.02.2025
Регистрационен номер
2024-514737-37-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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