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

Trial details

Who runs it

Arctic Bioscience AS

Trial code

EU 2022-501850-12-00

Record updated

2025. február 7.

Original description

The primary objective is to evaluate the clinical efficacy of two oral doses of HRO350 (1050 mg and 2100 mg daily) compared to placebo in patients with mild-to-moderate psoriasis in order to select the recommended dose for phase 3.Read full original descriptionShow less

A phase 2B, multicenter, randomized, double-blind, placebo-controlled, dose-finding, efficacy and safety study of HRO350 in subjects with mild-to-moderate psoriasis (the ‘HeROPA’ study)

The primary objective is to evaluate the clinical efficacy of two oral doses of HRO350 (1050 mg and 2100 mg daily) compared to placebo in patients with mild-to-moderate psoriasis in order to select the recommended dose for phase 3.

Inclusion: 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: 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; 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; Systemic anti-psoriatic treatment last 3 months (for biologics last 6 months) before randomisation and during the trial.

EU CTIS 2022-501850-12-00