To evaluate Baricitinib in Pediatric Patients with Atopic Dermatitis
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate to Severe Atopic Dermatitis
IRAS ID
253986
Contact name
Sophie Viollet
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-000349-38
Duration of Study in the UK
3 years, 7 months, 15 days
Research summary
Atopic Dermatitis (AD) is a common, chronic, relapsing and highly symptomatic inflammatory skin disease which is more prevalent in children than in adults. In AD, the skin becomes extremely itchy and inflamed, causing redness, swelling, blisters and scaling. Mild AD can be controlled by appropriate skin care and treatments applied directly to the affected areas (topical treatments). Moderate and severe AD may require additional treatments such as immune system supressing treatments (systemic treatments). Although topical treatments are used broadly in AD, patients may not achieve good disease control with topical treatments if they have moderate to severe disease. The safety profile of some currently available systemic treatments may also limit prolonged use of these treatments.
Inflammatory responses in the body can be triggered by the production of certain proteins. This response is important as it protects tissues in the body from injury for example by trauma or bacteria. In AD patients, however, this pathway can become over-stimulated. The Janus Kinase (JAK) pathway is a cell-signalling pathway that controls the production of these proteins. Baricitinib works by inhibiting the activity of some of these proteins thereby reducing the over-stimulation of this pathway in AD patients.
This study aims to evaluate the safety and efficacy of different doses of Baricitinib in Pediatric patients (aged 2 to 17 years) with moderate to severe AD who have responded inadequately to or who are intolerant to topical treatments. This study will involve 465 patients and will consist of 5 study periods including a screening phase, pharmacokinetic lead in phase, a double blind treatment phase, long term extension phase, and follow up period.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0057
Date of REC Opinion
15 Apr 2019
REC opinion
Further Information Favourable Opinion