An efficacy and safety study of HRO350 in patients with mild-to-moderate psoriasis (the ‘HeROPA’ study)

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0Level: PTClassification code: 10037153Term: Psoriasis Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2022-501850-12-00
• Lead Sponsor: Arctic Bioscience AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

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 which has been maintained without systemic treatment for at least 6 months prior to screening, Psoriasis Area and Severity Index (PASI) score = 3= 10 at screening and baseline, Body Surface Area (BSA) = 3 at screening and baseline, Static Physician’s Global Assessment (sPGA) = 2 = 4 at screening and baseline, Males, and females of child-bearing potential, 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 as implants, injectables, combined oral contraceptives, some Intrauterine Devices (IUDs), sexual abstinence (if this is the preferred and usual lifestyle of the patient) or vasectomized partner. Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for 12 months or more.

Exclusion Criteria

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 and 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified