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NCT06125808Recruiting

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

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).
Arctic BiosciencePhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Psoriasis
Drug/Device/Intervention
HRO350
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Arctic Bioscience
Location
Helsinki,Turku,Bad Bentheim,Bad Soden,Berlin,Berlin,Dresden,Dülmen,Essen,Friedrichshafen,Heidelberg,Kiel,Munich,Münster,Simmern,Stuttgart,Witten,Haukeland,Ålesund,Kraków,Puławy,Toruń,Warsaw,Barry,Bath, Finland,Germany,Norway,Poland,United Kingdom
Timeline & enrollment
Phase
Phase 2
Start date
May 25, 2023
End date
Feb 25, 2025
Enrollment
519 participants
Primary outcome

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

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.

ICD-10 classifications
PsoriasisOther psoriasisPsoriasis, unspecifiedArthropathic psoriasisPsoriasis vulgaris
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06125808
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06125808 through Pure Global AI's free database. This Phase 2 trial is sponsored by Arctic Bioscience and is currently Recruiting. The study focuses on Psoriasis. Target enrollment is 519 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.