A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema who are not Adequately Controlled With Topical Corticosteroids or When This Treatment is not Medically Advisable (LUMINE)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Nummular Dermatitis
Спонсор: Almirall S.A.
Налично на:
БГ
Обобщение
Trial status: Authorised
1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24, 2. Absolute change from baseline in DLQI to Week 24.
1. Percentage of participants achieving endpoint reduction from baseline at Week 24.
Описание
1. Percentage of participants with Pruritus NRS ≥4 at baseline achieving a ≥4-point improvement in Pruritus NRS score from baseline at Week 24, 2. Absolute change from baseline in DLQI to Week 24.
Кой може да участва
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 241 participants
Интервенции
Placebo
Drug
Ebglyss 250 mg solution for injection in pre-filled syringe
БГ
EN