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Monoclonal Antibodies

Amlitelimab for Atopic Dermatitis (SHORE) (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
Have you had atopic dermatitis for at least 1 year?
In the last six months, have you had a poor response to any topical medications?
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 24 weeks
Follow Up 16 weeks
Awards & highlights

Summary

The purpose of the SHORE Study is to test how well and safely a new investigational drug called amlitelimab works in participants with atopic dermatitis (AD) who are on concomitant background topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI).

Who is the study for?
You are eligible if you have been diagnosed with moderate-to-severe AD for a year or longer and used topical corticosteroids or topical calcineurin inhibitors without adequate benefit from topical medications within the last 6 months or used systemic therapies for AD without adequate benefit within the last 12 months.
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 ≥51% 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 ~ 24 weeks
Follow Up ~16 weeks
This trial's timeline: 2 weeks for screening, 24 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 (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 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
+28 more

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

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Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,979,282 Total Patients Enrolled
~298 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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