Home › Trials › NCT05769777

Long-term evaluation of amlitelimab for moderate to severe atopic dermatitis in patients aged 12 and older

An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

PHASE2 · Sanofi · NCT05769777

This study is testing if a new treatment called amlitelimab can safely help people aged 12 and older with moderate to severe atopic dermatitis over a long period of time.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment901 (estimated)
Ages12 Years and up
SexAll
SponsorSanofi (industry)
Drugs / interventionsamlitelimab
Locations184 sites (Birmingham, Alabama and 183 other locations)
Trial IDNCT05769777 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and efficacy of amlitelimab in participants aged 12 years and older who have moderate to severe atopic dermatitis. It is a single-group, open-label study lasting up to 180 weeks, which includes a treatment period of approximately 160 weeks and a post-treatment safety follow-up. Participants will undergo a total of 26 visits throughout the study to monitor their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 years and older with a documented history of moderate to severe atopic dermatitis and inadequate response to previous treatments.

Not a fit: Patients with mild atopic dermatitis or those who have not tried other treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe atopic dermatitis in patients.

How similar studies have performed: Other studies have shown promise with similar treatments for atopic dermatitis, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
* Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
* Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
* Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
* Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
* AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
* Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
* Able and willing to comply with requested study visits and procedures.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Exclusion Criteria:

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
* Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
* History of solid organ or stem cell transplant.
* Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
* Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
* Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
* In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
* In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
* History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

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

Where this trial is running

Birmingham, Alabama and 183 other locations

+134 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.