Efficacy and safety comparison of brodalumab versus guselkumab, COBRA
Research type
Research Study
Full title
Efficacy and safety comparison of brodalumab versus guselkumab in adult subjects with moderate-to-severe plaque psoriasis and inadequate response to ustekinumab; COBRA
IRAS ID
284772
Contact name
Ida-Eline Meyhoff
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2019-004099-20
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CPMS ID , 44745
Duration of Study in the UK
1 years, 10 months, 19 days
Research summary
Research Summary:
Psoriasis is a persistent and reoccurring skin disease characterised by patches of red, dry, itchy and scaly skin, occurring in approximately 2% of the population worldwide. Plaque psoriasis is the most common type of psoriasis, accounting for about 90% of all types.There are many different biologic treatment options for psoriasis. The purpose of this study is to compare effectiveness and safety of 2 different biologic treatments, brodalumab with guselkumab, as treatments for adults with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment. The results of this study will help patients and doctors decide on appropriate treatments in the future.
Participants will be treated with either brodalumab 210 mg or guselkumab 100 mg; treatment is given as an injection to the thigh, stomach area, or outer side of the upper arm.
The treatment received is chosen at random, which means selected by chance (like flipping a coin). Dummy injections are given so that participants and trial doctors cannot tell which treatment has been given. The dummy injection is a placebo; it will be the same as brodalumab except that it will not have any active ingredients in it.
During visits the trial doctor and team will assess the participant’s skin, conduct physical examinations, check vital signs and weight, collect blood and urine samples, perform pregnancy tests (where applicable), ask participants questions relating to their health, wellbeing and treatment and administer the trial treatment. Participants will also be asked to complete questionnaires on an electronic device.
The study will last up to 32 weeks for each participant and include a 2 to 4-week screening period and 28-week treatment period. This study is being funded by LEO Pharma and will be carried out in NHS hospitals throughout England.
Summary of Research:
Why was this clinical trial done?
To test two medicines for people with plaque psoriasis who continued to have psoriasis symptoms after treatment with ustekinumab.Who took part?
113 adult men and women with moderate to severe plaque psoriasis.What was tested?
Medicine A (brodalumab) was compared with medicine B (guselkumab).What did the clinical trial show?
It was not possible to make a firm conclusion on the results of the trial. The results of a clinical trial have some statistical uncertainty, as they are based on data from only a limited number of participants. For this trial, the uncertainty was so large that those treated with medicine A could not be firmly concluded to have greater improvement than those treated with medicine B.
19 of the 56 participants had side effects that the trial doctor thought might be caused by medicine A. The most common side effects with medicine A were:- Joint pain (2 of 56 participants)
- Headache (2 of 56 participants)
- Flu-like illness (2 of 56 participants)
- Vomiting (2 of 56 participants)REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0199
Date of REC Opinion
2 Sep 2020
REC opinion
Further Information Favourable Opinion