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A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
249 patients around the world
Available in Chile, United States
Sanofi
2Research sites
249Patients around the world
This study is for people with
Dermatitis
Atopic dermatitis
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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 prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.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).
Sites
Clínica Dermacross S.A. - Vitacura - Santiago
Recruiting
Centro Internacional de Estudios Clínicos - CIEC
Recruiting
StudyAQUA
SponsorSanofi
Conditions
Atopic dermatitis
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06241118
