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Monoclonal Antibodies

Amlitelimab + Topical Corticosteroids for Atopic Dermatitis (AQUA) (AQUA Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you had atopic dermatitis for at least 1 year?
Have you ever taken an oral medication specifically for your atopic dermatitis, such as Abrocitinib, Upadacitinib, or Baricitinib?
Must not have
Have you been diagnosed with any of the following: psoriasis, tinea corporis, or lupus erythematosus?
Have you experienced suicidal ideation or thoughts of self-harm in the past 6 months?
Timeline
Screening 2 weeks
Treatment 36 weeks
Follow Up 16 weeks
Awards & highlights
Pivotal Trial

Summary

The purpose of the AQUA Study is to test how well and safely a new investigational drug called amlitelimab works in participants with atopic dermatitis (AD) who are on background topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) and did not improve with previous biologic therapy or oral Janus Kinase (JAK) inhibitor treatment or are not tolerant to these treatments.

Who is the study for?
You are eligible if you have been diagnosed with moderate-to-severe AD for a year or longer and you are using concomitant topical corticosteroids or calcineurin inhibitors and your symptoms are not controlled with previous treatment for AD with biologic therapy or oral Janus Kinase (JAK) inhibitor treatment or you are not tolerant to these treatments.
What is being tested?
Atopic dermatitis is an immune system condition. The investigational drug, amlitelimab, is an immunotherapy that targets the inflammation cascade. It is aimed to calm the immune system to prevent inflammation. Amlitelimab has been shown to be well tolerated by patients in previous clinical studies but is not yet approved for treating atopic dermatitis.
What are the potential side effects?
The most frequently reported side effects in participants who received amlitelimab (reported in ≥ 5% of study participants) and more frequent compared to those who received placebo (a ≥ 1% difference between amlitelimab compared to placebo) were: nasopharyngitis, COVID-19 and headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 weeks
Treatment ~ 36 weeks
Follow Up ~16 weeks
This trial's timeline: 2 weeks for screening, 36 weeks for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Whether 2 different dosing regimens of amlitelimab can help improve the signs and symptoms of atopic dermatitis.
Whether treatment with amlitelimab offers the potential for significant long-term reduction in symptoms.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose 2: once every 12 weeksExperimental Treatment0 Interventions
Subcutaneous injection as per protocol. Topical corticosteroids may also be applied.
Group II: Amlitelimab dose 1: once every 4 weeksExperimental Treatment0 Interventions
Subcutaneous injection as per protocol. Topical corticosteroids may also be applied.
Group III: Placebo: once every 4 weeksPlacebo Group1 Intervention
Subcutaneous injection as per protocol

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,209 Previous Clinical Trials
4,039,517 Total Patients Enrolled
~156 spots leftby Mar 2026
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