Efficacy and Safety Study of HRO350 in Patients with Mild-to-moderate Psoriasis (the 'HeROPA' Study).

Last updated: March 21, 2025
Sponsor: Arctic Bioscience
Overall Status: Completed

Phase

2

Condition

Skin Wounds

Rash

Scalp Disorders

Treatment

HRO350

Placebo

Clinical Study ID

NCT06125808
HRO350-PS-2B 'HeROPA'
2021-003684-96
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed and dated informed consent.

  2. Males or females ≥18 years of age.

  3. Diagnosis of chronic, active plaque psoriasis of mild to moderate severity since atleast 6 months prior to screening.

  4. Psoriasis Area and Severity Index (PASI) score ≥ 3 and ≤ 10 at screening andbaseline

  5. Body Surface Area (BSA) ≥ 3 at screening and baseline

  6. Static Physician's Global Assessment (sPGA) ≥ 2 and ≤ 4 at screening and baseline.

  7. Males, and females of child-bearing potential1, must be willing to use highlyeffective methods of birth control during the study period and until 30 days afterend of treatment. Highly effective methods of birth control are defined as thosewhich result in a low failure rate (i.e. less than 1% per year) when usedconsistently and correctly. Such methods include:

  • Combined (oestrogen and progestogen containing hormonal contraceptionassociated with inhibition of ovulation -oral -intravaginal

  • transdermal

  • progestogen-only hormonal contraception associated with inhibition of ovulation -oral

  • injectable

  • implantable

  • intrauterine device

  • intrauterine hormone-releasing system

  • bilateral tubal occlusion

  • vasectomized partner

  • sexual abstinence (if this is the preferred and usual lifestyle of the patient)

  1. Female patients will be considered to be of childbearing potential as perthe Clinical Trial Facilitation Group (CTFG) definition of woman ofchildbearing potential: Fertile, following menarche and until becomingpost-menopausal unless permanently sterile. Permanent sterilisationmethods include hysterectomy, bilateral salpingectomy and bilateraloophorectomy. A postmenopausal state is defined as no menses for 12 monthswithout an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm apostmenopausal state in women not using hormonal contraception or hormonalreplacement therapy (HRT). However, in the absence of 12 months ofamenorrhea, confirmation with more than one FSH measurement is required.

Exclusion

Exclusion Criteria:

  1. Diagnosis of other psoriasis clinical subtypes such as guttate, erythrodermic orpustular psoriasis.

  2. Phototherapy [(i.e., ultraviolet radiation (UVB), psoralens and long-waveultraviolet radiation (PUVA)] within 8 weeks of randomisation and during the trial.

  3. Any investigational drug administered within 4 weeks of randomisation or <5 timeshalf-lives, whichever is the longer, and during the trial.

  4. Systemic anti-psoriatic treatment last 3 months (for biologics last 6 months) beforerandomisation or during the trial.

  5. Topical anti-psoriatic treatment last 2 weeks before randomisation.

  6. Any change in anti-inflammatory medication (for other chronic diseases thanpsoriasis) last 4 weeks before randomisation and during the trial.

  7. Any intake of omega-3 fatty acid supplements or medicines last 2 weeks beforerandomisation and during the trial.

  8. Known fish or vegetable oil (including soy) allergy, or allergy to other ingredientsin the study medication, placebo or rescue medication.

  9. Baseline white blood cell count <3.0x109/L or lymphocyte count <1.0x109/L, or otherpathological results identified during a complete blood count, which in the opinionof the investigator may preclude the patient being enrolled.

  10. Previous malignancies (except for non-melanoma skin cancer).

  11. Symptomatic coronary or cerebral vascular disease.

  12. Known congestive heart failure Grade IV by the New York Heart Association

  13. Myocardial infarction within 6 months prior to signing the ICF

  14. Onset of unstable angina within 6 months prior to signing the ICF

  15. Chronic kidney disease as evidenced by a calculated glomerular filtration rate (GFR) < 60ml/min/1.73m2 at screening.

  16. Abnormal liver function tests defined by:

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.

Study Design

Total Participants: 521
Treatment Group(s): 2
Primary Treatment: HRO350
Phase: 2
Study Start date:
May 25, 2023
Estimated Completion Date:
March 07, 2025

Study 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.

Connect with a study center

  • CRST Helsinki Oy

    Helsinki,
    Finland

    Site Not Available

  • CRST Turku Oy

    Turku,
    Finland

    Site Not Available

  • Fachklinik

    Bad Bentheim,
    Germany

    Site Not Available

  • Hautmedizin Bad Soden Studienzentrum GmbH

    Bad Soden,
    Germany

    Site Not Available

  • Hautarztpraxis Dr Wildfeuer

    Berlin,
    Germany

    Site Not Available

  • Isa Research - Interdisciplinary Study Organisation

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Dresden Klinik und Poliklinik für Dermatologie

    Dresden,
    Germany

    Site Not Available

  • Proderma, Institut für klinische Studien und innovative Dermatologie

    Dülmen,
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen,
    Germany

    Site Not Available

  • Derma-Study-Centre

    Friedrichshafen,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • University Clinic UKSH Kiel

    Kiel,
    Germany

    Site Not Available

  • Klinikum der Universität München

    Munich,
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster,
    Germany

    Site Not Available

  • Dermatologisches Studienzentrum Hunsrück am Haut -und Laserzentrum

    Simmern,
    Germany

    Site Not Available

  • Hautarztpraxis Dr. Leitz - Studienzentrum Triderm

    Stuttgart,
    Germany

    Site Not Available

  • Hautarztpraxis Dr. med. Matthias Hoffmann

    Witten,
    Germany

    Site Not Available

  • Haukeland University Hospital

    Haukeland,
    Norway

    Site Not Available

  • Ålesund Hospital

    Ålesund,
    Norway

    Site Not Available

  • Centrum Medyczne All-Med

    Kraków,
    Poland

    Site Not Available

  • KO-MED Centra Medyczne

    Puławy,
    Poland

    Site Not Available

  • MICS Centrum Medyczne

    Toruń,
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii

    Warsaw,
    Poland

    Site Not Available

  • The Practice of Health

    Barry,
    United Kingdom

    Site Not Available

  • Heart of Bath Medical Partnership

    Bath,
    United Kingdom

    Site Not Available

  • Waterloo Medical Centre

    Blackpool,
    United Kingdom

    Site Not Available

  • St Luke's Hospital

    Bradford,
    United Kingdom

    Site Not Available

  • Concord Medical Centre

    Bristol,
    United Kingdom

    Site Not Available

  • Royal Primary Care Ashgate

    Chesterfield,
    United Kingdom

    Site Not Available

  • Hathaway Medical Centre

    Chippenham,
    United Kingdom

    Site Not Available

  • Rowden Surgery

    Chippenham,
    United Kingdom

    Site Not Available

  • Lakeside Healthcare Research

    Corby,
    United Kingdom

    Site Not Available

  • University Hospital of North Durham

    Durham,
    United Kingdom

    Site Not Available

  • Haven Health

    Felixstowe,
    United Kingdom

    Site Not Available

  • Honiton Surgery

    Honiton,
    United Kingdom

    Site Not Available

  • Sherbourne Medical Practice

    Leamington Spa,
    United Kingdom

    Site Not Available

  • Oak Tree Surgery

    Liskeard,
    United Kingdom

    Site Not Available

  • Babylon Healthcare GP at Hand

    London,
    United Kingdom

    Site Not Available

  • Luton and Dunstable University Hospital

    Luton,
    United Kingdom

    Site Not Available

  • Kiltearn Medical Centre

    Nantwich,
    United Kingdom

    Site Not Available

  • Newquay Health Centre

    Newquay,
    United Kingdom

    Site Not Available

  • St Clare Medical Centre

    Penzance,
    United Kingdom

    Site Not Available

  • University Hospitals Dorset

    Poole,
    United Kingdom

    Site Not Available

  • Clarence House Medical Centre

    Rhyl,
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford,
    United Kingdom

    Site Not Available

  • Kings Mill Hospital

    Sutton In Ashfield,
    United Kingdom

    Site Not Available

  • Grove Surgery

    Thetford,
    United Kingdom

    Site Not Available

  • Trowbridge Health Centre

    Trowbridge,
    United Kingdom

    Site Not Available

  • West Walk Surgery

    Yate,
    United Kingdom

    Site Not Available

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