← Back to Search

Monoclonal Antibodies

Amlitelimab dose 1 for Atopic Dermatitis (SHORE 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

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

Body weight ≥40 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 40

Awards & highlights

SHORE Trial Summary

This trial is for people with moderate to severe atopic dermatitis who have not responded well to topical treatments. The purpose of the study is to see if amlitelimab solution, given as

Who is the study for?

Adults over 18 with moderate-to-severe atopic dermatitis (AD), also known as eczema, who haven't had enough relief from topical treatments can join. They must be using topical corticosteroids or calcineurin inhibitors.Check my eligibility

What is being tested?

The trial is testing Amlitelimab injections against a placebo in people with AD while they continue to use their regular skin creams. It's a double-blind study, meaning neither the participants nor the researchers know who gets the real drug.See study design

What are the potential side effects?

Possible side effects of Amlitelimab include reactions at the injection site, increased risk of infections due to immune system changes, and potential interference with normal immune responses.

SHORE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am at least 18 years old.

Select...

I weigh at least 40 kg.

Select...

My average daily pain score is 4 or more.

Select...

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

SHORE Trial 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

+35 more

SHORE 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 calcineurin inhibitors

2019

Completed Phase 3

~320

Topical corticosteroids

2004

Completed Phase 3

~2420

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,484 Total Patients Enrolled

Frequently Asked Questions

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

Has the first dosage of Amlitelimab received official approval from the FDA?

"Based on the fact that this trial is in Phase 3 and there are multiple rounds of safety data available, our team at Power rates the safety of Amlitelimab dose 1 as a score of 3."

Answered by AI

What is the current number of individuals receiving medical care as part of this clinical trial?

"Indeed, the data provided on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible participants. The trial was first listed on January 15th, 2024 and its most recent update occurred on January 16th, 2024. A total of 496 patients are being recruited from a single site for this study."

Answered by AI

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

"Indeed, the information on clinicaltrials.gov confirms that this study is currently seeking eligible participants. The trial was initially posted on January 15th, 2024 and recently updated on January 16th, 2024. Recruitment aims to enroll a total of 496 patients from one designated site."

Answered by AI