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

Phase 1

Recruiting

• Conditions: Dermatitis atopic; MedDRA version: 20.0Level: PTClassification code: 10012438Term: Dermatitis atopic Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-506558-20-00
• Lead Sponsor: Sanofi-Aventis Recherche & Developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

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

Exclusion Criteria

Skin co-morbidity that would adversely affect the ability to undertake AD assessments, History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified