Dose ADJUSTment for >120kg subjects with moderate to severe psoriasis
Research type
Research Study
Full title
Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ≥120 kg body weight
IRAS ID
278492
Contact name
Anton Poterajlo
Contact email
Sponsor organisation
ICON Clinical (UK) Limited
Eudract number
2017-004998-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 6 days
Research summary
Psoriasis is an inflammatory disorder occurring in around 2% of the population worldwide. Plaque psoriasis is characterised as raised, scaly and red skin lesions (plaques) usually on the scalp, elbows, knees and sacrum, which can be painful and itchy. Psoriasis is associated with a range of other health issues including diabetes mellitus, cardiovascular disease, depression and anxiety.
Evidence shows that obesity can make the development of psoriasis more likely, and can worsen existing psoriasis. Obesity also increases the risk of cardiovascular disease.
In psoriasis patients, an immune response is activated. IL-17 is a human protein involved in immune and inflammatory responses, raised levels of which are found in psoriatic plaques. Brodalumab is a human antibody, a type of systemic biological drug, which binds to a receptor of this protein (IL-17RA). This blocks the IL-17 pathway and by doing so interrupts the inflammatory process of psoriasis, which may improve or clear the symptoms. Brodalumab is approved in the EU for treatment of adults with moderate to severe psoriasis.
This is a randomised, double-blind trial to compare the effect on psoriasis symptoms of an adjustable brodalumab dosage regimen to standard brodalumab treatment in subjects with moderate-to-severe psoriasis and a body weight ≥120 kg.
The trial consists of 3 periods: 2 to 4-week screening period, 52-
week treatment period (divided into 16-week induction period and 36-week
dose adjustment period), and 8-week safety follow-up.Study assessments will include blood tests, physical exam, ECG, questionnaires, skin & subcutaneous adipose tissue biopsy (tissue biopsy done as part of sub-study at selected sites only, none in the UK).
This study is sponsored by Leo Pharma. Approximately 384 patients will be recruited globally with approximately 10 in the UK.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0181
Date of REC Opinion
4 Aug 2020
REC opinion
Favourable Opinion