Dermira Announces Initiation of Phase 3 Program Evaluating Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis - Seite 2

Key patient inclusion criteria for the monotherapy studies include the presence of chronic atopic dermatitis for at least one year, an Investigator’s Global Assessment (IGA) score of 3 or 4 (on a 5-point scale ranging from 0 to 4), an Eczema Area Severity Index (EASI) score of 16 or greater and body surface area (BSA) involvement of at least 10 percent at screening and baseline.

The studies will evaluate a 250 mg dose of lebrikizumab administered by subcutaneous injection every two weeks, following a loading dose of 500 mg administered at baseline (day 0) and week 2, compared to placebo for 16 weeks (the induction period). Following the end of the 16-week induction period, study patients who respond during the induction period (as evidenced by achievement of an IGA 0/1 response, representing a reduction of 2 or more points in IGA score from baseline to a final score of 0 (clear) or 1 (almost clear), or an EASI-75 response, representing an improvement in EASI score of at least 75 percent from baseline) will be re-randomized to one of the following treatment groups for an additional 36-week maintenance period:

• Group A: Lebrikizumab 250 mg given every two weeks;
• Group B: Lebrikizumab 250 mg given every four weeks; or
• Group C: Placebo given every two weeks.

Patients who do not achieve an IGA of 0/1 response or an EASI-75 response at week 16 and patients who do not maintain an EASI-50 response during the maintenance period will be assigned to receive lebrikizumab 250 mg as open-label treatment every two weeks through week 52.

The primary efficacy endpoint of the studies is the percentage of patients with an IGA 0/1 response from baseline to week 16.

Key secondary efficacy endpoints that will be evaluated during the 16-week induction period include: the percentage of patients achieving EASI-75; the percentage of patients achieving EASI-90; the percentage of patients with a pruritus (itch) numerical rating (NRS) score of at least 4 at baseline who achieve a reduction of at least 4 points; percentage changes in pruritus and sleep-loss scores; and change in BSA.

The company expects to report topline findings from the 16-week induction period in the first half of 2021. In addition to the two monotherapy studies, the company plans to include a study in the Phase 3 program that evaluates lebrikizumab when used in combination with topical corticosteroids. The impact of lebrikizumab treatment on quality of life will also be assessed across a number of additional measures.