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NCT06790121 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis
A Phase 2 study of Dermatitis, Atopic, sponsored by Sanofi.
- Active
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06790121 is a Phase 2 study of Dermatitis, Atopic that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 150 participants, below the 392-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT06790121, a Phase 2 study of Dermatitis, Atopic, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lunsekimig
Study Locations (20)
Indiana
- Southern Indiana Clinical Trials-Site Number: 8400024 - New Albany
- Indiana Clinical Trials Center, P.C.-Site Number: 8400018 - Plainfield
- Optima Research-Site Number: 8400019 - Plainfield
- Options Research Group-Site Number: 8400012 - West Lafayette
California
- T. Joseph Raoof MD Inc-Site Number: 8400004 - Encino
- Integrative Skin Science and Research-Site Number: 8400002 - Sacramento
- Clinical Trials Research Institute-Site Number: 8400003 - Thousand Oaks
Florida
- Skin Care Research-Site Number: 8400013 - Boca Raton
- Driven Research LLC-Site Number: 8400020 - Coral Gables
Georgia
- Revival Research Institute, LLC-Site Number: 8400021 - Evans
Idaho
- Treasure Valley Medical Research-Site Number: 8400026 - Boise
Kentucky
- DS Research - Kentucky-Site Number: 8400005 - Louisville
Louisiana
- Clinical Trials Management LLC-Site Number: 8400010 - Covington
Massachusetts
- Beacon Clinical Research-Site Number: 8400006 - Quincy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-01-30 |
| Est. Completion | 2026-04-13 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06790121
The ClinicalTrials.gov registry entry for NCT06790121 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 392-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (62% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06790121 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Indiana, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06790121 about?
NCT06790121 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis". 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 eff...
What is the current status of trial NCT06790121?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-01-30. Estimated completion is 2026-04-13.
What conditions does trial NCT06790121 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT06790121?
The interventions under investigation include: Placebo (DRUG), Lunsekimig (DRUG).
Who is sponsoring clinical trial NCT06790121?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06790121 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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