Efficacy and Safety of Lebrikizumab in Adults With Nummular Dermatitis Inadequately Controlled by Topical Corticosteroids: A Phase 3, Randomized, Placebo-Controlled Study

The primary objective is to evaluate the efficacy of lebrikizumab compared to placebo in adult patients with nummular eczema through 24 weeks of treatment. This investigation focuses on individuals whose condition is not adequately controlled with topical corticosteroids or for whom such therapy is not medically advisable. Secondary objectives include the assessment of safety in this patient population.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, both male and female, diagnosed clinically with nummular eczema. Participants must have exhibited signs or symptoms of the condition for a minimum of 6 months prior to screening. The study targets individuals whose disease is not adequately controlled with topical corticosteroids or for whom such treatment is not medically advisable. Inclusion requires the ability to provide informed consent and compliance with the study protocol.

This Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicentre study evaluates the efficacy and safety of lebrikizumab in adult patients diagnosed with nummular eczema. Participants who are not adequately controlled with topical corticosteroids or for whom such treatment is not medically advisable are eligible for enrollment. The study methodology compares the administration of lebrikizumab via subcutaneous injection against a placebo. The primary objective is to assess the percentage of participants achieving a specific endpoint reduction from baseline at Week 24. Secondary endpoints include improvements in the Pruritus NRS score and absolute changes in the Dermatology Life Quality Index. The trial includes a screening visit to confirm clinical diagnosis and a double-blind extension phase. The total duration of participant involvement is determined by the clinical protocol and the scheduled follow-up visits through the end of the study period.

The experimental treatment consists of lebrikizumab, provided as Ebglyss. The medication is administered as a 250 mg solution for injection in a pre-filled syringe via subcutaneous injection.

The control group receives a placebo.

The primary efficacy endpoint is the percentage of participants achieving a specified reduction from baseline at Week 24. Secondary efficacy assessments include the proportion of participants with a baseline Pruritus NRS score of 4 or greater who achieve an improvement of at least 4 points from baseline at Week 24. Additionally, the absolute change from baseline in the Dermatology Life Quality Index will be evaluated at Week 24.