Regeneron Pharmaceuticals and Sanofi have started dosing patients in a Phase III clinical trial of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD).
LIBERTY AD CHRONOS is the first trial in the Phase III clinical programme for dupilumab and its primary objective is to show the efficacy of dupilumab in adults with moderate to severe AD when administered concomitantly with topical corticosteroids through 16 weeks.
The LIBERTY AD Phase III clinical programme will include at least five trials of patients with moderate-to-severe AD at sites across the world.
Around 700 adult patients will be enrolled in this randomised, double-blind, placebo-controlled, multi-national trial and its secondary objectives will be to evaluate the long-term safety and efficacy of dupilumab up to 52 weeks.
National Jewish Health head of the Division of Pediatric Allergy and Immunology and member of the LIBERTY AD Clinical Trials Steering Committee Donald Leung said: "Moderate-to-severe atopic dermatitis is a serious disease characterised by severe itching, sleep disturbances and widespread rash, and existing treatment options have limited efficacy.
"This Phase III programme will evaluate if blocking IL-4 and IL-13, two key cytokines in the Th2 inflammatory pathway, may provide a potential new approach for this chronic, difficult-to-manage disease."
Moderate-to-severe atopic dermatitis is a systemic inflammatory disease characterised by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells.
IL-4 and IL-13 are major cytokines that are required to start and maintain this Th2 immune response.
Dupilumab was created using Regeneron's VelocImmune technology and is being co- developed with Sanofi to treat atopic dermatitis, asthma and chronic sinusitis with nasal polyposis.
Image: Atopic dermatitis of the anterior flextural crease of the elbow. Photo: courtesy of James Heilman.