New York location for dermatology study by Equity Medical
Study Location
New York

Overview

Recruiting start date
  • Currently Enrolling
Duration
  • 24 Weeks
Population

Individuals aged 12 and above with moderate-to-severe Atopic Dermatitis (AD) that is inadequately controlled with topical treatments.

Study Drug

Subcutaneous Amlitelimab injection (80%) or placebo (20%) monotherapy injection. Subjects randomized to placebo who are non-responders will receive drug after 20 weeks.

Background: Amlitelimab, an OX40 ligand inhibitor, showed best-in-class efficacy, potential disease modification, and no dose-responsive safety signals in its phase 2B trial. This study aims to further explore the efficacy and safety of Amlitelimab in a larger population.

Inclusion Criteria
  • EASI score greater than 16
  • IGA score of 3 or 4
  • Body surface area (BSA) affected greater than 10%
  • Weekly average pruritus-numerical rating scale (PP-NRS) score greater than 4
Exclusion Criteria
  • History of significant immunosuppression
  • Malignancy
  • Solid organ or stem cell transplant
  • Active infection
Prior/Concomitant Therapy

Previous use of oral or topical JAK inhibitors is allowed if not exceeding 6 months. A 12-week washout period is required for biologics such as Dupilumab, Tralokinumab, and Lebrikizumab prior to the baseline visit.

Compensation
  • Participants will receive $50 per visit
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