Investigating Lunsekimig for Moderate-to-Severe Atopic Dermatitis
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
This study is testing a new treatment called lunsekimig to see if it can help adults with moderate-to-severe eczema who haven't found relief from other creams.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 16 sites (Encino, California and 15 other locations) |
| Trial ID | NCT06790121 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of lunsekimig, a subcutaneous treatment, in adults with moderate-to-severe atopic dermatitis who have not responded adequately to topical therapies. The study is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial with multiple dosing regimens. Participants will be monitored over a period of approximately 36 weeks, which includes screening, treatment, and safety follow-up phases. The trial aims to determine the effectiveness of lunsekimig compared to a placebo in alleviating symptoms of atopic dermatitis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a documented history of moderate-to-severe atopic dermatitis and inadequate response to topical therapies.
Not a fit: Patients with mild atopic dermatitis or those who have not tried topical treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from moderate-to-severe atopic dermatitis who have not benefited from existing topical treatments.
How similar studies have performed: Other studies have shown promise with similar biologic treatments for atopic dermatitis, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Encino, California and 15 other locations
- T. Joseph Raoof MD Inc-Site Number: 8400004 — Encino, California, United States (Recruiting)
- Clinical Trials Research Institute-Site Number: 8400003 — Thousand Oaks, California, United States (Recruiting)
- Skin Care Research-Site Number: 8400013 — Boca Raton, Florida, United States (Recruiting)
- Driven Research LLC-Site Number: 8400020 — Coral Gables, Florida, United States (Recruiting)
- Southern Indiana Clinical Trials-Site Number: 8400024 — New Albany, Indiana, United States (Recruiting)
- Indiana Clinical Trials Center, P.C.-Site Number: 8400018 — Plainfield, Indiana, United States (Recruiting)
- Clinical Trials Management LLC-Site Number: 8400010 — Covington, Louisiana, United States (Recruiting)
- Medisearch LLC-Site Number: 8400017 — Saint Joseph, Missouri, United States (Recruiting)
- Skin Cancer and Dermatology Institute-Site Number: 8400011 — Reno, Nevada, United States (Recruiting)
- Red River Research Partners-Site Number: 8400008 — Fargo, North Dakota, United States (Recruiting)
- Health Concepts-Site Number: 8400025 — Rapid City, South Dakota, United States (Recruiting)
- DermResearch-Site Number: 8400014 — Austin, Texas, United States (Recruiting)
- Investigational Site Number: 3920005 — Asahikawa-shi, Japan (Recruiting)
- Investigational Site Number: 3920006 — Nerima-ku, Japan (Recruiting)
- Investigational Site Number: 3920008 — Tachikawa-shi, Japan (Recruiting)
- Investigational Site Number: 3920007 — Yokohama-shi, Japan (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.