Home › Trials › NCT06241118

Evaluating Amlitelimab for Moderate-to-Severe Atopic Dermatitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Phase 3 Interventional Sanofi · NCT06241118

This study is testing a new injection called amlitelimab to see if it can help people aged 12 and older with moderate-to-severe eczema who haven't had success with other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment636 (estimated)
Ages12 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsamlitelimab
Locations147 sites (Birmingham, Alabama and 146 other locations)
Trial IDNCT06241118 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial investigates the efficacy and safety of subcutaneous amlitelimab in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who have not responded adequately to previous biologic therapies or oral JAK inhibitors. The study is designed as a randomized, double-blind, placebo-controlled trial with three arms, comparing amlitelimab to placebo while participants continue their topical corticosteroid therapy. The trial will last up to 56 weeks, including a screening period, a randomized treatment phase, and a safety follow-up. Participants may also have the option to enter a long-term safety study after the trial concludes.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 years and older with a diagnosis of moderate-to-severe atopic dermatitis and a history of inadequate response to prior biologic therapy or oral JAK inhibitors.

Not a fit: Patients with significant skin co-morbidities or those with current immunosuppression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with moderate-to-severe atopic dermatitis who have not responded to existing therapies.

How similar studies have performed: Previous studies have shown promise with similar biologic therapies for atopic dermatitis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

Participants are excluded from the study if any of the following criteria apply:

* 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)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Where this trial is running

Birmingham, Alabama and 146 other locations

+97 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Dermatitis Atopic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.