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ACTIVE NOT RECRUITING 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

NCT06790121 · View on ClinicalTrials.gov ↗

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

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

Sponsor

Sanofi

275 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06790121 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Indiana, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06790121?

The interventions under investigation include: Placebo (DRUG), Lunsekimig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06790121?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial