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 taken Dupilumab (otherwise known as Dupixent) or Tralokinumab (otherwise known as Adbry) to treat your atopic dermatitis?

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 weeks1 visit

Treatment ~ 36 weeks11 visits

Follow Up ~ 16 weeks1 visit

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

EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36

US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36

Secondary study objectives

Absolute change in SCORAD index from baseline

Absolute change in weekly average of daily PP-NRS from baseline

Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline

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