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Investigating vaccine responses in adults with atopic dermatitis treated with amlitelimab

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis

Phase 2 Interventional Sanofi · NCT06015308

This study is testing whether a new treatment called amlitelimab can help adults with moderate-to-severe atopic dermatitis have a better response to vaccines.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment215 (estimated)
Ages18 Years and up
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsamlitelimab
Locations57 sites (Birmingham, Alabama and 56 other locations)
Trial IDNCT06015308 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter, randomized, double-blind placebo-controlled study evaluates the effects of amlitelimab on vaccine antibody responses in adults with moderate-to-severe atopic dermatitis. Participants will receive either amlitelimab or a placebo while being administered non-live vaccines, specifically Boostrix and Pneumovax 23. The primary endpoint is to measure the percentage of participants achieving a positive anti-tetanus response at Week 16, with a key secondary endpoint focusing on the anti-pneumococcal response. The study duration is up to 36 weeks, including a screening period of 9 days to 4 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate-to-severe atopic dermatitis who have not responded adequately to topical treatments.

Not a fit: Patients with skin co-morbidities affecting assessment or those who have received certain vaccines recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance vaccine efficacy in patients with atopic dermatitis receiving amlitelimab.

How similar studies have performed: Other studies have shown promise in evaluating vaccine responses in patients with similar conditions, but this specific approach with amlitelimab is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must be 18 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
* Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit
* Eczema area and severity index (EASI) score of 12 or higher at baseline
* AD involvement of 10% or more of body surface area (BSA) at baseline
* Able and willing to comply with requested study visits and procedures
* Body weight ≥40 kg and ≤150 kg

Exclusion Criteria:

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening
* Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening
* Prior receipt of two or more doses of Pneumovax 23 at any time
* Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
* Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
* Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (excluding 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 2 weeks prior baseline
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB

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 56 other locations

+7 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.