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Monoclonal Antibodies

Amlitelimab dose 1 for Atopic Dermatitis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52

Awards & highlights

AQUA Trial Summary

This trial is testing a new treatment for people with moderate-to-severe atopic dermatitis who have not responded well to other therapies. The study will compare the effectiveness and safety of the new treatment,

Who is the study for?

This trial is for people aged 12 and older with moderate-to-severe atopic dermatitis (AD), who weigh at least 40 kg, have had AD for a year or more, and didn't get better with previous biologic or oral JAK inhibitor treatments. They should have an EASI score of 16+ and be willing to follow the study plan.Check my eligibility

What is being tested?

The trial tests Amlitelimab injections against a placebo in participants with AD while they continue using topical corticosteroids. It's randomized, double-blind, and includes up to 13 visits over a maximum of 56 weeks, with some entering a long-term safety study afterwards.See study design

What are the potential side effects?

Possible side effects are not specified here but typically may include reactions at the injection site, increased risk of infections due to immune system changes, headaches, nausea, or other symptoms related to immune response alterations.

AQUA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+35 more

AQUA Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose 2Experimental Treatment3 Interventions

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1Experimental Treatment3 Interventions

Subcutaneous injection as per protocol

Group III: PlaceboPlacebo Group3 Interventions

Subcutaneous injection as per protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topical corticosteroids

2004

Completed Phase 3

~2420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,731 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of the initial dosage of amlitelimab in individuals?

"Based on the fact that this trial is in Phase 3, indicating previous evidence of safety and efficacy, our team at Power rates the safety of Amlitelimab dose 1 as a 3."

Answered by AI

Are individuals currently being enrolled in this medical study?

"Correct. The details on clinicaltrials.gov affirm that this research project is actively seeking participants. It was initially listed on February 29th, 2024, and last modified on March 15th, 2024. They aim to recruit 249 patients from nine different sites."

Answered by AI

Can you confirm if there are multiple locations conducting this clinical trial in North America?

"Encino Research Center Site Number : 8401042 in Encino, Center for Dermatology Clinical Research Site Number : 8401018 in Fremont, and Investigational Site Number : 1240028 in Regina are among the 9 sites actively seeking eligible participants for this research study."

Answered by AI

How many individuals in total are enrolled in this clinical study?

"Indeed, as per clinicaltrials.gov, this trial is actively seeking participants. Originally posted on February 29th, 2024, and last updated on March 15th, 2024, the study aims to enroll a total of 249 individuals distributed across nine locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

2024. "A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06241118.

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