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About
HRO350 contains an oil-based extract from herring roe (Clupea harengus) in soft capsules and contains phospholipids (complex lipids) which are naturally rich in marine polyunsaturated fatty acids. 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. The study is a randomised, double-blind, placebo controlled, dose finding, multi-centre, phase 2B study. Approximately 519 patients will be participating in the UK, Norway, Germany, Finland and Poland. Patients will receive either 1050mg or 2100mg HRO0350 daily, or placebo for up to 52 weeks and will be followed up for a further 8 weeks.
Full description
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 psoriasis severity. The total length of participation will be up to 60 weeks including an 8 week follow-up period.
Enrollment
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Inclusion criteria
Signed and dated informed consent.
Males or females ≥18 years of age.
Diagnosis of chronic, active plaque psoriasis of mild to moderate severity since at least 6 months prior to screening.
Psoriasis Area and Severity Index (PASI) score ≥ 3 and ≤ 10 at screening and baseline
Body Surface Area (BSA) ≥ 3 at screening and baseline
Static Physician's Global Assessment (sPGA) ≥ 2 and ≤ 4 at screening and baseline.
Males, and females of child-bearing potential1, must be willing to use highly effective methods of birth control during the study period and until 30 days after end of treatment. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
Combined (oestrogen and progestogen containing hormonal contraception associated with inhibition of ovulation -oral
-intravaginal
progestogen-only hormonal contraception associated with inhibition of ovulation -oral
intrauterine device
intrauterine hormone-releasing system
bilateral tubal occlusion
vasectomized partner
sexual abstinence (if this is the preferred and usual lifestyle of the patient)
Exclusion criteria
a. AST (SGOT), ALT (SGPT) or alkaline phosphatase (ALP) >3x the upper limit of the normal range (ULN). Elevated gamma-GT (GGT) values exceeding >3x ULN are allowed but these GGT cases will be carefully assessed alongside other clinical and laboratory data by the investigator. q. History of severe gastrointestinal problems. r. Ongoing, active infectious disease. s. Known human immunodeficiency virus (HIV)-positive status or suffering from any other immunosuppressive disease. t. History of major psychiatric illness that could interfere with the conduct of the study.
u. Patients with documented or suspected, clinically significant, alcohol (i.e., > 12g/d for women and 24 g/d for men) or drug abuse within the past 12 months.
v. Any other significant, unstable medical condition that would interfere with the completion of the study or interpretation of results.
w. Women of child-bearing potential* must have a negative serum pregnancy test at Visit 1 (Screening) and a negative urine pregnancy test at Visit 2 (Baseline). x. Females who are pregnant, breast feeding, refuse to use birth control methods or who wish to become pregnant during the study period.
y. Unable to comply with the requirements of the study or who in the opinion of the investigator is unable to comply with the requirements of the study.
Primary purpose
Allocation
Interventional model
Masking
521 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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