Tralokinumab in moderate-severe AD extension trial 1337
Research type
Research Study
Full title
Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ECZTEND
IRAS ID
251974
Contact name
Hoang Dang
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2018-000746-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 16 days
Research summary
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 open-label, unblinded trial is to evaluate the long-term safety of tralokinumab in patients who have participated in previous tralokinumab trials. In the UK, these previous trials are protocol codes LP0162-1326 and LP0162-1339. This trial will evaluate adverse events, the percentage of subjects achieving Investigator assessments of clear/almost clear skin and the percentage of subjects achieving at least 75% reduction in an eczema specific severity index at various points. A variety of patient-reported outcomes (including sleep loss and itch severity) will be collected.
As AD is a chronic disease, the efficacy of tralokinumab as a long-term treatment will be evaluated from week 0 to week 136. The trial treatment will stop by May 2021 though; if this date comes first, the duration of treatment for each patient will depend on when they join this trial.Summary of results:
During the ~5 years of the trial, 1421 of the 1672 participants reported 8119 side effects. This means that 85% of the participants in the trial reported at least 1 side effect during the 5 years.
The chart below shows the number of subjects with and without side effects during the trial.
15% of the participants without side effects during the trial.
85% of the participants with side effects during the trial.Most of the reported side effects were not serious and were mild to moderate in intensity.
534 of the 1672 participants (32%) had side effects that the trial doctor thought might be caused by the trial medicine.Most common side effects (seen in at least 1 in every 20 participants) Among the participants who took the trial medicine, the most common side effects were:
• Worsening of atopic dermatitis (in 108 adults and 1 child out of 1672 participants, 6.5%) • Common cold (in 98 adults out of 1672 participants, 5.9%)This was the main result of the trial. The last section of this summary shows where you can find the rest of the results.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0281
Date of REC Opinion
14 Nov 2018
REC opinion
Further Information Favourable Opinion