Tralokinumab in moderate-severe AD -1326
Research type
Research Study
Full title
Tralokinumab monotherapy for moderate-to-severe atopic dermatitis ECZTRA 2 (ECZema TRAlokinumab trial no. 2)
IRAS ID
222154
Contact name
Beverley Benning
Contact email
Sponsor organisation
LEO Pharma
Eudract number
2016-004201-13
Duration of Study in the UK
2 years, 4 months, 7 days
Research summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease that may affect up to 20% of children and up to 10% of adults. In its severe form, AD is characterised by widespread skin lesions, itch, poor quality of life and a higher risk of bacterial, viral, and fungal skin infections.
Current treatments usually include topical corticosteroids (TCS). These have limited efficacy in patients with moderate-to-severe disease. TCS and some other treatments (including some systemic therapies) are associated with toxicities with long-term use. Patients inadequately controlled with topical therapies are candidates for systemic therapy.
In AD patients, an immune response is activated. Tralokinumab is a human antibody, a type of systemic biological drug, which binds to a human protein called Interleukin-13 (IL-13). IL-13 is involved in the body’s immune responses to fight diseases but also increases skin cell production and decreased barrier function, leading to itch. By binding to IL-13, tralokinumab may improve or clear the symptoms of AD.
The primary objective of this randomised, double-blinded trial is to demonstrate that tralokinumab provides more effective control of AD than placebo. The trial will evaluate the percentage of subjects achieving Investigator assessments of clear/almost clear and the percentage of subjects achieving at least 75% reduction in an eczema-specific severity index at Week 16, with secondary endpoints addressing symptom scores and a variety of patient-reported outcomes (including itch severity).
As AD is a chronic disease, the efficacy of tralokinumab as maintenance treatment will be evaluated from week 16 to week 52. After the 16-week initial treatment period, the trial will evaluate 2 different treatment regimens vs. placebo (randomised, double-blind) for maintenance therapy. Where treatment is unsuccessful and only after week 16, the patient may attempt tralokinumab open-label therapy during the maintenance period.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1147
Date of REC Opinion
10 Aug 2017
REC opinion
Further Information Favourable Opinion