A study to evaluate the efficacy and safety of subcutaneous amlitelimab in participants aged 18 years and older with moderate-to-severe atopic dermatitis on background topical corticosteroids (SHORE)

Recruiting

• Conditions: Dermatitis atopic

• Registration Number: jRCT2061230090
• Lead Sponsor: Sanofi K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-13
• Last Update Posted: 2024-01-13

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

• Participants must be 18 years of age (when signing informed consent form)
• Diagnosis of atopic dermatitis (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)
• Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 3 or 4 at baseline visit
• Eczema Area and Severity Index (EASI) score of 16 or higher at baseline
• AD involvement of 10% or more of Body Surface Area (BSA) at baseline
• Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of >= 4 at baseline visit
• Able and willing to comply with requested study visits and procedures
• Body weight >=40 kg

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• 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 (excluding for 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 baseline
• Positive for human immunodeficiency virus, 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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of >=2 points at Week 24	Week 24	The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24	Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of >=2 points at Week 24	Week 24	Refer to the primary outcome-1 for "vIGA-AD".