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

NCT06125808 | Completed Phase 2 DMC

• 2 other identifiers: HRO350-PS-2B 'HeROPA'2021-003684-96
• Study Type: interventional
• Target: 521
• Locations: 5 countries
• Sites: 49

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI50).

  The PASI assesses efficacy in moderate-to-severe psoriasis and quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percentage of body surface area (BSA)" affected. To be included on the study, patients Psoriasis Area and Severity Index (PASI) score needs to be ≥ 3 and ≤ 10, indicating mild-to-moderate Psoriasis. The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI) from baseline to week 26 will be compared between: HRO350 2100 mg and placebo, and HRO350 1050 mg and placebo.

  From Baseline to Week 26

Secondary Outcomes (12)

• Comparisons of Psoriasis Area and Severity Index (PASI) scores

  From baseline to week 4, 12, 26, 39, 52 and 60

• Body Surface Area (BSA)

  From baseline to week 12, 26, 39, 52 and 60

• static Physician Global Assessment (sPGA)

  Baseline, Week 4, Week 12, Week 26, Week 39, Week 52, and Week 60.

• static Physician's Global Assessment (sPGA) x Body Surface Area (BSA) product

  From baseline to week 4, 12, 26, 39, 52 and 60

• Scalp PGA (ScPGA)

  From baseline to week 4, 12, 26, 39, 52 and 60

Study Arms (3)

1050 mg HRO350

EXPERIMENTAL

1050 mg HRO350 daily given as 3 capsules of HRO350 (350 mg) in the morning and 3 capsules of placebo in the evening. Total of 6 capsules daily.

Drug: HRO350; Drug: Placebo

2100 mg HRO350

EXPERIMENTAL

2100 mg HRO350 daily given as 3 capsules of HRO350 in the morning and 3 capsules of HRO350 in the evening. Total of 6 capsules daily.

Drug: HRO350

Placebo

PLACEBO COMPARATOR

Placebo given as 3 capsules of placebo in the morning and 3 capsules of placebo in the evening, Total of 6 capsules daily.

Drug: Placebo

Interventions

HRO350 DRUG

Active substance phospholipid esters from herring roe oil (PEHeRo)

1050 mg HRO350; 2100 mg HRO350

Placebo DRUG

Placebo; as a sunflower oil in capsules similar to the interventional drug product HRO350 in terms of appearance, smell and taste.

1050 mg HRO350; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation -oral
• injectable
• implantable
• intrauterine device
• intrauterine hormone-releasing system

You may not qualify if:

• Diagnosis of other psoriasis clinical subtypes such as guttate, erythrodermic or pustular psoriasis.
• Phototherapy \[(i.e., ultraviolet radiation (UVB), psoralens and long-wave ultraviolet radiation (PUVA)\] within 8 weeks of randomisation and during the trial.
• Any investigational drug administered within 4 weeks of randomisation or \<5 times half-lives, whichever is the longer, and during the trial.
• Systemic anti-psoriatic treatment last 3 months (for biologics last 6 months) before randomisation or during the trial.
• Topical anti-psoriatic treatment last 2 weeks before randomisation.
• Any change in anti-inflammatory medication (for other chronic diseases than psoriasis) last 4 weeks before randomisation and during the trial.
• Any intake of omega-3 fatty acid supplements or medicines last 2 weeks before randomisation and during the trial.
• Known fish or vegetable oil (including soy) allergy, or allergy to other ingredients in the study medication, placebo or rescue medication.
• Baseline white blood cell count \<3.0x109/L or lymphocyte count \<1.0x109/L, or other pathological results identified during a complete blood count, which in the opinion of the investigator may preclude the patient being enrolled.
• Previous malignancies (except for non-melanoma skin cancer).
• Symptomatic coronary or cerebral vascular disease.
• Known congestive heart failure Grade IV by the New York Heart Association
• Myocardial infarction within 6 months prior to signing the ICF
• Onset of unstable angina within 6 months prior to signing the ICF
• Chronic kidney disease as evidenced by a calculated glomerular filtration rate (GFR) \< 60ml/min/1.73m2 at screening.

Sponsors & Collaborators

• Arctic Bioscience: lead
• Smerud Medical Research International AS: collaborator

Study Sites (49)

CRST Helsinki Oy

Helsinki, Finland

Location

CRST Turku Oy

Turku, Finland

Location

Fachklinik

Bad Bentheim, Germany

Location

Hautmedizin Bad Soden Studienzentrum GmbH

Bad Soden, Germany

Location

Hautarztpraxis Dr Wildfeuer

Berlin, Germany

Location

Isa Research - Interdisciplinary Study Organisation

Berlin, Germany

Location

Universitätsklinikum Dresden Klinik und Poliklinik für Dermatologie

Dresden, Germany

Location

Proderma, Institut für klinische Studien und innovative Dermatologie

Dülmen, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Derma-Study-Centre

Friedrichshafen, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

University Clinic UKSH Kiel

Kiel, Germany

Location

Klinikum der Universität München

Munich, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Dermatologisches Studienzentrum Hunsrück am Haut -und Laserzentrum

Simmern, Germany

Location

Hautarztpraxis Dr. Leitz - Studienzentrum Triderm

Stuttgart, Germany

Location

Hautarztpraxis Dr. med. Matthias Hoffmann

Witten, Germany

Location

Ålesund Hospital

Ålesund, Norway

Location

Haukeland University Hospital

Haukeland, Norway

Location

Centrum Medyczne All-Med

Krakow, Poland

Location

KO-MED Centra Medyczne

Puławy, Poland

Location

MICS Centrum Medyczne

Torun, Poland

Location

Narodowy Instytut Geriatrii

Warsaw, Poland

Location

The Practice of Health

Barry, United Kingdom

Location

Heart of Bath Medical Partnership

Bath, United Kingdom

Location

Waterloo Medical Centre

Blackpool, United Kingdom

Location

St Luke's Hospital

Bradford, United Kingdom

Location

Concord Medical Centre

Bristol, United Kingdom

Location

Royal Primary Care Ashgate

Chesterfield, United Kingdom

Location

Hathaway Medical Centre

Chippenham, United Kingdom

Location

Rowden Surgery

Chippenham, United Kingdom

Location

Lakeside Healthcare Research

Corby, United Kingdom

Location

University Hospital of North Durham

Durham, United Kingdom

Location

Haven Health

Felixstowe, United Kingdom

Location

Honiton Surgery

Honiton, United Kingdom

Location

Oak Tree Surgery

Liskeard, United Kingdom

Location

Babylon Healthcare GP at Hand

London, United Kingdom

Location

Luton and Dunstable University Hospital

Luton, United Kingdom

Location

Kiltearn Medical Centre

Nantwich, United Kingdom

Location

Newquay Health Centre

Newquay, United Kingdom

Location

St Clare Medical Centre

Penzance, United Kingdom

Location

University Hospitals Dorset

Poole, United Kingdom

Location

Clarence House Medical Centre

Rhyl, United Kingdom

Location

Sherbourne Medical Practice

Royal Leamington Spa, United Kingdom

Location

Salford Royal Hospital

Salford, United Kingdom

Location

Kings Mill Hospital

Sutton in Ashfield, United Kingdom

Location

Grove Surgery

Thetford, United Kingdom

Location

Trowbridge Health Centre

Trowbridge, United Kingdom

Location

West Walk Surgery

Yate, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: November 9, 2023
• Study Start: May 25, 2023
• Primary Completion: October 7, 2024
• Study Completion: March 7, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

FI (2); GB (26); DE (15); NO (2); PL (4)