HeROPA
Research type
Research Study
Full title
A phase 2B, multicenter, randomized, double-blind, placebo-controlled, dose-finding, efficacy and safety study of HRO350 in patients with mild-to-moderate psoriasis (the ‘HeROPA’ study)
IRAS ID
1006508
Contact name
Amanda Knock
Contact email
Sponsor organisation
Arctic Bioscience AS
Eudract number
2021-003684-96
Clinicaltrials.gov Identifier
Research summary
This study is a phase 2 multi-national (Norway, Germany, Finland, Poland and the UK), multi-centre (approx 66 sites), randomised, and placebo-controlled study assessing the dose, efficacy and safety of HRO350 in patients with mild-to-moderate psoriasis.
HRO350 contains phospholipids (complex lipids) which are naturally rich in marine polyunsaturated fatty acids that come from herring roe. All the lipids in HRO350 are natural components of the human diet. It is not fully known how HRO350 exerts its effects, however there are indications that it might have a modulatory effect on the inflammatory processes involved in causing psoriasis.
There are limited treatment options available for patients with mild-to-moderate psoriasis that provide treatment satisfaction and an improvement in quality of life. Therefore, the purpose of this study is to investigate the efficacy and safety of HRO350 in patients with mild to moderate psoriasis and help decide which doses should be included for further testing to provide the ‘best’ or optimal effects of HR0350.
Approximately 519 patients with mild-to-moderate psoriasis will be included in this study. The screening visit will include a review of the eligibility for the study, a physical examination, review of vital signs and blood and urine samples collected as part of the safety assessment along with assessment of their psoriasis severity. Daily treatment will begin with 3 capsules of either HRO350 or placebo taken in the morning and 3 capsules of either HRO350 or placebo taken in the evening for up to 52 weeks.
The patients will be asked to attend the clinic for a total of 8 visits and will receive 8 phone calls for safety checks and assessment of their psoriasis severity. The total length of participation will be up to 60 weeks including an 8 weeks follow-up period.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0799
Date of REC Opinion
23 Dec 2022
REC opinion
Further Information Favourable Opinion