NCT05706870

Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 in Plaque Psoriasis

A Multicenter Randomized Double-blind Placebo-controlled Parallel Group Phase II Study Evaluating the Clinical Efficacy and Safety of GN-037 Cream Used in the Treatment of Mild to Moderate Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago

Detailed description

A total of 190 patients aged between 18-65 years diagnosed with plaque psoriasis are planned to be included in the study. The study consists of three periods: Screening period: Within 4 weeks before baseline visit (-28 days to 0 days) Treatment period: 4 weeks Follow-up period with observation: 4 weeks The study is planned to last a maximum of 12 weeks for each patient. Study consists of 5 visits: baseline (day 1), week 2, week 4, week 6 and week 8 which is a follow-up period with observation.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GN-037	GN-037
DRUG	Clobetasol 17-propionate	Clobetasol 17-propionate
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-12-07
• Primary completion: 2024-01-04
• Completion: 2024-03-03
• First posted: 2023-01-31
• Last updated: 2025-07-16

Locations

18 sites across 1 country: Turkey (Türkiye)