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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501850-12-00

Acronym

HRO350-PS-2B HeROPA

Enrollment

376

Registered

2023-03-01

Start date

2023-03-15

Completion date

2025-03-07

Last updated

2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Brief summary

Proportion of patients with PASI50 (i.e., a ≥50% reduction in PASI score) from baseline to week 26

Detailed description

Static PGA (sPGA), BSA, sPGA × BSA product, Scalp PGA (ScPGA) Scale, Use of rescue medication, Dermatology Life Quality Index (DLQI), SF-36, Safety endpoints include adverse events, biochemical and haematological lab tests, discontinuation rates., Psoriasis Symptom Inventory (PSI), Treatment Satisfaction Score (TSS)

Interventions

DRUGBETAMETHASONE VALERATE

DRUGInert refined sunflower oil (998mg) provided in 1000mg fill-weight oblong 20 soft capsules. Other ingredients: 2 mg dl-alpha-tocopherol (antioxidant)

DRUGred iron oxide (for colorisation)

DRUGand liquid peach flavour (for aromatization).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with PASI50 (i.e., a ≥50% reduction in PASI score) from baseline to week 26	—

Secondary

Measure	Time frame
Static PGA (sPGA), BSA, sPGA × BSA product, Scalp PGA (ScPGA) Scale, Use of rescue medication, Dermatology Life Quality Index (DLQI), SF-36, Safety endpoints include adverse events, biochemical and haematological lab tests, discontinuation rates., Psoriasis Symptom Inventory (PSI), Treatment Satisfaction Score (TSS)	—

Countries

Finland, Germany, Norway, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026