Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
25 March 2026
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🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE2
Participants
ALL
Age Range
12 Years+
About This Trial
This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).
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.
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.
Who Can Join?
Inclusion Criteria: * Participant must be at least 12 years of age inclusive, at the time of signing the informed consent. * 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. * Able and willing…
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