Last updated 19 days ago

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

496 patients around the world

Available in Chile, Argentina, United States

Sanofi

2Research sites

496Patients around the world

This study is for people with

Dermatitis

Atopic dermatitis

From 12 Years

All Gender

: Participants must be 12 years of age (when signing informed consent form)
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
Documented history (within 6 months before screening) of inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
v-IGA-AD of 3 or 4 at baseline visit
EASI score of 16 or higher at baseline
AD involvement of 10% or more of BSA at baseline
Weekly average of daily PP-NRS of ≥ 4 at baseline visit
Able and willing to comply with requested study visits and procedures
Body weight ≥25 kg

: Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression
Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
History of solid organ or stem cell transplant
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

Investigaciones Médicas IMOBA SRL

Recruiting

Viamonte 2168, C1056ABH Cdad. Autónoma de Buenos Aires, Argentina

Clínica Dermacross S.A. - Vitacura - Santiago

Recruiting

Av. Manquehue Norte 2051 C, Vitacura, Metropolitana, 7640881

StudySHORE

SponsorSanofi

Conditions

Atopic dermatitis

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06224348