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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT05769777•Sanofi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

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 to comply with requested study visits and procedures.
•Body weight must be greater than or equal to 25 kg.
•Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

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.
•Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
•Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
•Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
•Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
•Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
+6 more criteria

Locations (175)

Allervie Clinical Research - Birmingham- Site Number : 8400050

Birmingham, Alabama, United States

Research Solutions of Arizona- Site Number : 8400020

Litchfield Park, Arizona, United States

Dermatology Trial Associates- Site Number : 8400027

Bryant, Arkansas, United States

University Dermatology Trials- Site Number : 8400052

Newport Beach, California, United States

Children's Hospital Colorado - Aurora- Site Number : 8400041

Aurora, Colorado, United States

IMMUNOe International Research Centers - Centennial- Site Number : 8400024

Centennial, Colorado, United States

Renaissance Research and Medical Group- Site Number : 8400006

Cape Coral, Florida, United States

Florida Pharmaceutical Research and Associates- Site Number : 8400018

Miami, Florida, United States

Miami Clinical Research Tower- Site Number : 8400036

Miami, Florida, United States

Florida Research Center- Site Number : 8400011

Miami, Florida, United States

Key Dates

Start Date

April 3, 2023

Primary Completion Date

June 11, 2031

Completion Date

June 11, 2031

Last Updated

March 10, 2026

Enrollment

901

ESTIMATED participants

Conditions

Dermatitis Atopic

Interventions

Amlitelimab

DRUG

Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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