Atopic Dermatitis Clinical Study (12 yrs+)

An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Amlitelimab in Participants aged 12 Years and Older with Moderate-to-Severe Atopic Dermatitis

Study Description

The study duration per participant will be up to 284 weeks, including:

A screening period of up to 2 to 4 weeks

An open label treatment period of up to 268 weeks (approximately 5 years)

A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264)

The planned number of visits will be 35 visits.

Brief Summary

The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.

Condition or Disease

Atopic Dermatitis

Study Design

Study Type:	Interventional (Clinical Trial)
Estimated Enrollment:	901
Primary Outcome Measures	1. Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) 2. Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Actual Study Start Date:	April 2023
Estimated Primary Completion Date:	June 2031

Eligibility Criteria

Ages Eligible for Study:	12 & Older
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Study Population

Atopic Dermatitis

Inclusion Criteria

Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline
Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit)
Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2
Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2
AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2
Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2
Body weight must be greater than or equal to 25 kg.

Exclusion Criteria

Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator’s judgement
Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline)
History of solid organ or stem cell transplant
Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed

ADDITIONAL DETAILS

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Moderate-to-Severe Atopic Dermatitis Study (12 Years+)