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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: Active Phase 2 study of Dermatitis, Atopic, sponsored by Sanofi.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

Conditions Studied

Dermatitis, Atopic

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

FieldValue
Enrollment Target 150 participants
Start Date 2025-01-30
Est. Completion 2026-04-13
Phase Phase 2
Sanofi

713 total trials

What the registry record for NCT06790121 still lists

NCT06790121 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 392-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (62% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Dermatitis, Atopic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06790121's enrollment target sits among peer trials

150 19th of 29 higher than 10 of 29 other Dermatitis, Atopic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dermatitis, Atopic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06790121, the US trial registry maintained by the National Library of Medicine. NCT06790121 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.