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Monoclonal Antibodies

Amlitelimab dose 2 for Atopic Dermatitis

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

Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)

Participants must be 18 years of age (when signing informed consent form)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 40

Awards & highlights

Study Summary

This trial is testing a medication called amlitelimab for the treatment of moderate to severe atopic dermatitis (AD). The study will compare the effectiveness and safety of amlitelimab

Who is the study for?

This trial is for adults over 18 with moderate-to-severe atopic dermatitis (AD), also known as eczema, who haven't had success with topical treatments or can't use them. Participants should have a history of AD for at least one year and meet certain severity criteria like an EASI score of 16+ and involvement of 10% or more body surface area.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Amlitelimab, given by subcutaneous injection, compared to a placebo in treating AD. It's a double-blind trial meaning neither participants nor researchers know who gets the real treatment versus placebo during the study which lasts up to 24 weeks.See study design

What are the potential side effects?

While specific side effects are not listed here, common side effects from similar medications may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, cold symptoms, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with atopic dermatitis for over a year.

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I am at least 18 years old.

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My average pain score is 4 or more.

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10% or more of my skin is affected by atopic dermatitis.

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I weigh at least 40 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 40 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 (EASI-75) at Week 24

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 24

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 24

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

+33 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose 2Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1Experimental Treatment1 Intervention

Subcutaneous injection as per protocol

Group III: PlaceboPlacebo Group1 Intervention

Subcutaneous injection as per protocol

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,560 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"As per the data available on clinicaltrials.gov, this trial is actively seeking individuals to participate. The initial posting date was December 21st, 2023 and it underwent its most recent update on January 10th, 2024."

Answered by AI

What is the current number of participants involved in this research investigation?

"Indeed, the data available on clinicaltrials.gov confirms that this study is actively seeking participants. It was originally posted on December 21st, 2023 and last updated on January 10th, 2024. The trial aims to enroll a total of 420 participants at a single site."

Answered by AI

What level of risk does the first dosage of Amlitelimab pose to patients?

"Given that this is a Phase 3 trial, implying the availability of efficacy data and multiple rounds of safety data, our team at Power rates the safety level of Amlitelimab dose 1 as a 3 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

2023. "A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06181435.

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