Clinical trial NCT06790121: A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24
Secondary outcomes:
measure: Proportion of participants achieving EASI-75 at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a reduction from Baseline of ≥2 points at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with reduction (improvement) of ≥4 in the weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Absolute change from Baseline in EASI score at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change from Baseline in EASI score throughout the study
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from Baseline of ≥2 points throughout the study
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change in the weekly average of daily PPNRS scores from Baseline to Week 24
timeFrame: From Baseline throughout tje study, up to Week 24
measure: Percent change in the weekly average of daily sleep disturbance NRS score from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change in the weekly average of daily skin pain NRS score from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from Baseline to Week 24.
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants achieving EASI-50 at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants achieving EASI-90 at Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily PP NRS scores from Baseline throughout the study
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily SD-NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily SD-NRS scores of ≥4 points
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily Skin Pain NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily Skin Pain NRS scores of ≥4 points
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24
measure: Proportion of participants with an improvement of ≥4 points in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study
timeFrame: From Baseline throughout the study, up to Week 24
measure: Percent change in Patient Oriented Eczema Measure (POEM) score from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to Week 24,
measure: Percent change in Hospital Anxiety and Depression Scale (HADS) from Baseline to Week 24
timeFrame: From Baseline throughout the study, up to to Week 24
measure: Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study
timeFrame: From Baseline throughout the study, up to Week 32
measure: Serum concentrations of lunsekimig throughout the study
timeFrame: From Baseline throughout the study, up to Week 32
measure: Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study
timeFrame: From Baseline throughout the study, up to Week 32
measure: Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)
timeFrame: From Baseline throughout the study, up to Week 32
Other outcomes:
Locations:
city: Encino
country: United States
facility: T. Joseph Raoof MD Inc-Site Number: 8400004
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute-Site Number: 8400003
state: California
city: Boca Raton
country: United States
facility: Skin Care Research-Site Number: 8400013
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC-Site Number: 8400020
state: Florida
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials-Site Number: 8400024
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center, P.C.-Site Number: 8400018
state: Indiana
city: Covington
country: United States
facility: Clinical Trials Management LLC-Site Number: 8400010
state: Louisiana
city: Saint Joseph
country: United States
facility: Medisearch LLC-Site Number: 8400017
state: Missouri
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute-Site Number: 8400011
state: Nevada
city: Fargo
country: United States
facility: Red River Research Partners-Site Number: 8400008
state: North Dakota
city: Rapid City
country: United States
facility: Health Concepts-Site Number: 8400025
state: South Dakota
city: Austin
country: United States
facility: DermResearch-Site Number: 8400014
state: Texas
city: Asahikawa-shi
country: Japan
facility: Investigational Site Number: 3920005
city: Nerima-ku
country: Japan
facility: Investigational Site Number: 3920006
city: Tachikawa-shi
country: Japan
facility: Investigational Site Number: 3920008
city: Yokohama-shi
country: Japan
facility: Investigational Site Number: 3920007
Study officials:
References: