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

Description

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.

Conditions

Dermatitis Atopic

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Study Overview

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Study Details

Study overview

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.

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis

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

Condition
Dermatitis Atopic
Intervention / Treatment

-

Contacts and Locations

Encino

T. Joseph Raoof MD Inc-Site Number: 8400004, Encino, California, United States, 91436

Thousand Oaks

Clinical Trials Research Institute-Site Number: 8400003, Thousand Oaks, California, United States, 91320

Boca Raton

Skin Care Research-Site Number: 8400013, Boca Raton, Florida, United States, 33486

Coral Gables

Driven Research LLC-Site Number: 8400020, Coral Gables, Florida, United States, 33134

New Albany

Southern Indiana Clinical Trials-Site Number: 8400024, New Albany, Indiana, United States, 47150

Plainfield

Indiana Clinical Trials Center, P.C.-Site Number: 8400018, Plainfield, Indiana, United States, 46168

Covington

Clinical Trials Management LLC-Site Number: 8400010, Covington, Louisiana, United States, 70433

Saint Joseph

Medisearch LLC-Site Number: 8400017, Saint Joseph, Missouri, United States, 64506

Reno

Skin Cancer and Dermatology Institute-Site Number: 8400011, Reno, Nevada, United States, 89509

Fargo

Red River Research Partners-Site Number: 8400008, Fargo, North Dakota, United States, 58103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
  • * Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
  • * Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
  • * Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
  • * Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
  • * AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
  • * Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
  • * Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives \[eg, urea\]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).
  • * Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
  • * Known history of, or suspected, significant current immunosuppression

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2026-07-15