ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-02-03
Study Completion:2026-04-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06790121

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
  2. * 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)
  3. * Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
  4. * Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
  5. * 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).
  6. * AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
  7. * Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
  8. * 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).
  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.
  2. * Known history of, or suspected, significant current immunosuppression

Contacts and Locations

Study Locations (Sites)

T. Joseph Raoof MD Inc-Site Number: 8400004
Encino, California, 91436
United States
Clinical Trials Research Institute-Site Number: 8400003
Thousand Oaks, California, 91320
United States
Skin Care Research-Site Number: 8400013
Boca Raton, Florida, 33486
United States
Driven Research LLC-Site Number: 8400020
Coral Gables, Florida, 33134
United States
Southern Indiana Clinical Trials-Site Number: 8400024
New Albany, Indiana, 47150
United States
Indiana Clinical Trials Center, P.C.-Site Number: 8400018
Plainfield, Indiana, 46168
United States
Clinical Trials Management LLC-Site Number: 8400010
Covington, Louisiana, 70433
United States
Medisearch LLC-Site Number: 8400017
Saint Joseph, Missouri, 64506
United States
Skin Cancer and Dermatology Institute-Site Number: 8400011
Reno, Nevada, 89509
United States
Red River Research Partners-Site Number: 8400008
Fargo, North Dakota, 58103
United States
Health Concepts-Site Number: 8400025
Rapid City, South Dakota, 57702
United States
DermResearch-Site Number: 8400014
Austin, Texas, 78759
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03
Study Completion Date2026-04-13

Study Record Updates

Study Start Date2025-02-03
Study Completion Date2026-04-13

Terms related to this study

Additional Relevant MeSH Terms

  • Dermatitis Atopic