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Evaluating Amlitelimab for Moderate-to-Severe Atopic Dermatitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

PHASE3 · Sanofi · NCT06181435

This study is testing a new injection called amlitelimab to see if it helps people aged 12 and older with moderate to severe eczema feel better compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment547 (estimated)
Ages12 Years and up
SexAll
SponsorSanofi (industry)
Drugs / interventionsamlitelimab
Locations141 sites (Scottsdale, Arizona and 140 other locations)
Trial IDNCT06181435 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is designed to assess the efficacy and safety of amlitelimab, a subcutaneous injection, compared to a placebo in participants aged 12 years and older with moderate to severe atopic dermatitis. The study involves a randomized, double-blind, placebo-controlled approach across multiple centers and countries. Participants will undergo a screening period followed by a 24-week treatment phase and a 16-week safety follow-up. Those who complete the treatment may have the option to enter a separate blinded extension study.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 years and older with a documented diagnosis of moderate to severe atopic dermatitis and inadequate response to topical or systemic therapies.

Not a fit: Patients with significant immunosuppression, malignancies, or other skin co-morbidities that affect assessment 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 do not respond adequately to existing therapies.

How similar studies have performed: Other studies have shown promise with similar biologic treatments 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 (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
* 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 patient's potential participation in a clinical trial.

Where this trial is running

Scottsdale, Arizona and 140 other locations

+91 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 →

Conditions: Dermatitis Atopic

Last reviewed 2026-05-15 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.