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?

Timeline

Screening 7 days

Treatment 24 weeks

Follow Up 16 weeks

Awards & highlights

Pivotal Trial

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

Timeline

Screening ~ 7 days1 visit

Treatment ~ 24 weeks10 visits

Follow Up ~ 16 weeks1 visit

Screening ~ 7 days

Treatment ~ 24 weeks

Follow Up ~16 weeks

This trial's timeline: 7 days 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

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