Tralokinumab in adolescents with moderate-severe AD -1334
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, parallel-group, multicentre trial to evaluate the efficacy, safety, and tolerability of tralokinumab monotherapy in adolescent subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy - ECZTRA 6 (ECZema TRAlokinumab trial no.6)
IRAS ID
251374
Contact name
Stine Kihl-Plambek
Contact email
Sponsor organisation
LEO Pharma
Eudract number
2017-005143-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Atopic dermatitis (AD) is a type of eczema 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 include steroid cream or ointment (topical corticosteriods), that have limited efficacy in some patients with moderate-to-severe disease. Alternative treatments include systemic therapies (tablets or injections) that potentially are associated with toxicities with long-term use.
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 main purpose of this trial is to test if the trial drug, tralokinumab, is better than a dummy treatment (placebo) at treating moderate to severe AD in adolescents between the ages of 12 to 17 years. 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. Additional endpoints address 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 4 different treatment regimes 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
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0301
Date of REC Opinion
19 Nov 2018
REC opinion
Further Information Favourable Opinion