CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 202 enrolled
Drug / intervention
Orismilast modified release tablets +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05190419
NCT05190419Phase 2Completed

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

UNION therapeutics·interventional·Posted Jan 13, 2022·Updated Apr 16, 2024

In Brief

A Phase 2 clinical trial evaluating Orismilast modified release tablets and Placebo for Psoriasis and Skin Diseases. Completed, enrolled 202 participants across 34 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 13, 2022
Enrollment StartDec 30, 2021
Primary CompletionNov 24, 2022
Study CompletionDec 20, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.5 years ago

Interventions

Orismilast modified release tabletsdrug

Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Placebodrug

Matching placebo tablets