A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
Public ClinicalTrials.gov record NCT06790121. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06790121
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 29, 2025
- Primary completion
- Feb 11, 2026
- Completion
- Apr 8, 2026
- Last update posted
- Apr 20, 2026
2025 – 2026
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| T. Joseph Raoof MD Inc-Site Number: 8400004 | Encino | California | 91436 | — |
| Integrative Skin Science and Research-Site Number: 8400002 | Sacramento | California | 95815 | — |
| Clinical Trials Research Institute-Site Number: 8400003 | Thousand Oaks | California | 91320 | — |
| Skin Care Research-Site Number: 8400013 | Boca Raton | Florida | 33486 | — |
| Driven Research LLC-Site Number: 8400020 | Coral Gables | Florida | 33134 | — |
| Revival Research Institute, LLC-Site Number: 8400021 | Evans | Georgia | 30809 | — |
| Treasure Valley Medical Research-Site Number: 8400026 | Boise | Idaho | 83706 | — |
| Southern Indiana Clinical Trials-Site Number: 8400024 | New Albany | Indiana | 47150 | — |
| Indiana Clinical Trials Center, P.C.-Site Number: 8400018 | Plainfield | Indiana | 46168 | — |
| Optima Research-Site Number: 8400019 | Plainfield | Indiana | 46168 | — |
| Options Research Group-Site Number: 8400012 | West Lafayette | Indiana | 47906 | — |
| DS Research - Kentucky-Site Number: 8400005 | Louisville | Kentucky | 40241 | — |
| Clinical Trials Management LLC-Site Number: 8400010 | Covington | Louisiana | 70433 | — |
| Beacon Clinical Research-Site Number: 8400006 | Quincy | Massachusetts | 02169 | — |
| Somerset Skin Centre-Site Number: 8400009 | Troy | Michigan | 48084 | — |
| Medisearch LLC-Site Number: 8400017 | Saint Joseph | Missouri | 64506 | — |
| Skin Cancer and Dermatology Institute-Site Number: 8400011 | Reno | Nevada | 89509 | — |
| Icahn School of Medicine at Mount Sinai-Site Number: 8400023 | New York | New York | 10029 | — |
| Red River Research Partners-Site Number: 8400008 | Fargo | North Dakota | 58103 | — |
| Health Concepts-Site Number: 8400025 | Rapid City | South Dakota | 57702 | — |
| DermResearch-Site Number: 8400014 | Austin | Texas | 78759 | — |
| Progressive Clinical Research-Site Number: 8400001 | San Antonio | Texas | 78213 | — |
| Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015 | Burien | Washington | 98168 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06790121, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06790121 live on ClinicalTrials.gov.