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Amlitelimab for Moderate-to-Severe Atopic Dermatitis

This study is testing a new injectable medicine called amlitelimab for people aged 12 and older with moderate-to-severe atopic dermatitis (AD), also known as eczema. You might be eligible if your AD hasn't improved enough with previous biologic treatments or oral JAK inhibitors, and you're currently using topical corticosteroids. The study aims to see how well amlitelimab works and if it's safe compared to a placebo (an inactive substance). Researchers will measure success by looking at how much your skin clears up and how much your eczema symptoms improve after 36 weeks of treatment.

Study design
This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled study involving 636 participants. It has three groups to compare amlitelimab against a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
After the main treatment period, you may have the option to join a long-term safety study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06241118

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Active, Not Recruiting
PHASE3Ages 12+InterventionalTreatment
Sanofi
~464 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:AmlitelimabPlaceboTopical corticosteroidsTopical tacrolimus or pimecrolimus

At a glance

Recruiting sites
0 of 150 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36
Measured over Week 36
+2 more outcomes measured

Conditions

Dermatitis Atopic

Explore related trials

Atopic Dermatitis

Where it's being run

150 sites across 73 states
China15
California8
Florida6
France6
Germany6
Ontario5
Reg Metropolitana de Santiago5
Greece4

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must be 12 years of age (when signing informed consent form)
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
v-IGA-AD of 3 or 4 at baseline visit
EASI score of 16 or higher at baseline
AD involvement of 10% or more of BSA at baseline
Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
Able and willing to comply with requested study visits and procedures
Body weight ≥25 kg

Exclusion

Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression
Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
History of solid organ or stem cell transplant
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

What this trial measures

  • EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36Week 36

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  • EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36Week 36

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  • US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36Week 36

    The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).