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

NCT06125808 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2025-03-25

No results posted yet for this 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.

Conditions

Interventions

DRUG

HRO350

Active substance phospholipid esters from herring roe oil (PEHeRo)

DRUG

Placebo

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

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • Arctic Bioscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2024-10-07
Completion
2025-03-07

Countries

  • Finland
  • Germany
  • Norway
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125808 on ClinicalTrials.gov