BREEZE-AD4 - Baricitinib in moderate to severe atopic dermatitis
Research type
Research Study
Full title
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Efficacy of Barcitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis who have Experienced Failure to Cyclosporine or are Intolerant to, or have Contraindication to Cyclosporine
IRAS ID
235876
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Eli Lilly Cork Ltd
Eudract number
2017-004574-34
Duration of Study in the UK
1 years, 11 months, 15 days
Research summary
Atopic dermatitis (AD) is a common (aprox 20-25%) chronic, relapsing and highly symptomatic inflammatory skin disease. In atopic dermatitis, the skin becomes extremely itchy and inflamed, causing redness, swelling, vesicle formation (small blisters), cracking, weeping, crusting, and scaling. Mild AD can be controlled by appropriate skin care and treatments applied directly to the affected areas; moderate and severe AD usually requires additional treatments such as light treatment or immune system suppressing treatments (systemic treatments).
The safety profile of some current systemic treatments limits their use to the short-term treatment of chronic severe AD. Therefore, there is the need for alternative therapy for patients with moderate to severe AD requiring systemic therapies.
Baricitinib has been investigated or is being investigated for the treatment of inflammatory disesases.
The JAK pathway is a cell-signalling pathway that controls the production of proteins which trigger the inflammatory response. The inflammatory response is important to protect tissues in the body from injury for example by trauma or bacteria. However, in AD patients this pathway is over stimulated. Baricitinib works by inhibiting the activity of some of these proteins, reducing and controlling the over stimulation of this pathway.
This study aims to evaluate the safety and efficacy of different doses of baricitinib compared with placebo in patients who have moderate to severe AD and are receiving topical corticosteroid (TCS) treatment and who have experienced failure to, are intolerant to, or have contraindication to the immune system suppressing treatment; cyclosporine.REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0095
Date of REC Opinion
27 Mar 2018
REC opinion
Further Information Favourable Opinion