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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Dermatitis Atopic

Treatments: Drug: Lunsekimig; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06790121

U1111-1299-1958 (Registry Identifier)

2024-511549-20 (Registry Identifier)

DRI18252

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion 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).

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• 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

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 6 patient groups, including a placebo group

Lunsekimig arm A

Experimental group

Description:

Participants will receive subcutaneous injection of lunsekimig dosing regimen A.

Treatment:

Drug: Lunsekimig

Placebo arm B

Placebo Comparator group

Description:

Participants will receive subcutaneous injection of matching placebo.

Treatment:

Drug: Placebo

Lunsekimig arm C

Experimental group

Description:

Participants will receive subcutaneous injection of lunsekimig dosing regimen C.

Treatment:

Drug: Lunsekimig

Placebo arm D

Placebo Comparator group

Description:

Participants will receive subcutaneous injection of matching placebo.

Treatment:

Drug: Placebo

Lunsekimig arm E

Experimental group

Description:

Participants will receive subcutaneous injection of lunsekimig dosing regimen E.

Treatment:

Drug: Lunsekimig

Placebo arm F

Placebo Comparator group

Description:

Participants will receive subcutaneous injection of matching placebo.

Treatment:

Drug: Placebo