A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Conditions

• Dermatitis Atopic

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Lunsekimig — DRUG
  Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
• Placebo — DRUG
  Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Study Details

This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD). This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup. The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.

Key Dates

Start date

Jan 30, 2025

Status verified

Apr 2026

Primary completion

Feb 12, 2026

Completion

Apr 9, 2026

Study Design

Enrollment

150 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lunsekimig arm A
  Participants will receive subcutaneous injection of lunsekimig dosing regimen A.
• Placebo Comparator: Placebo arm B
  Participants will receive subcutaneous injection of matching placebo.
• Experimental: Lunsekimig arm C
  Participants will receive subcutaneous injection of lunsekimig dosing regimen C.
• Placebo Comparator: Placebo arm D
  Participants will receive subcutaneous injection of matching placebo.
• Experimental: Lunsekimig arm E
  Participants will receive subcutaneous injection of lunsekimig dosing regimen E.
• Placebo Comparator: Placebo arm F
  Participants will receive subcutaneous injection of matching placebo.

Primary Outcome Measure

Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24 [ Time Frame: From Baseline throughout the study, up to Week 24 ]

Locations (23)

Find similar trials in Encino, CA

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