Last updated 15 days ago

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

420 patients around the world

Available in Chile, United States

Sanofi

1Research sites

420Patients 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 either inadequate response or inadvisability 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 (1 week in the event of superficial skin infections).
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).

Centro Internacional de Estudios Clínicos - CIEC

Recruiting

Calle Manzano 343, Oficina 410-411, Comuna de Recoleta, Región Metropolitana, 8420383

StudyCOAST 1

SponsorSanofi

Conditions

Atopic dermatitis

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06130566