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)
Phase 3 – large-scale trial before approval
Conditions:
Nummular Dermatitis
Sponsor: Almirall S.A.
trial.available_in:
БГ
Overview
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.
Description
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.
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 241 participants
Interventions
Placebo
Drug
Ebglyss 250 mg solution for injection in pre-filled syringe
БГ