NCT05469464

Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

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 Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (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 atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis 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

• Atopic Dermatitis
• Skin Diseases

Interventions

Type	Name	Description
DRUG	Orismilast modified release tablets	Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: * UNI50001 * LEO32731
DRUG	Placebo	Placebo matching tablets

Timeline

• Start date: 2022-07-11
• Primary completion: 2024-01-23
• Completion: 2024-02-15
• First posted: 2022-07-21
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

48 sites across 4 countries: United States, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study