NCT05190419

Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate-to-Severe Plaque-Type Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: UNION therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

Conditions

• Psoriasis
• Skin Diseases

Interventions

Type	Name	Description
DRUG	Orismilast modified release tablets	Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
DRUG	Placebo	Matching placebo tablets

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-11-24
• Completion: 2022-12-20
• First posted: 2022-01-13
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

34 sites across 4 countries: United States, Germany, Poland, United Kingdom

Regulatory

• FDA-regulated drug study