Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

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.

Timeline

Start

2021-12-30

Primary completion

2022-11-24

Completion

2022-12-20

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Tablets BID vs Orismilast Modified Release Tablets 20 mg BID; p <0.001; Mean Difference (Net) -35.4 (95% CI -54.7 to -16.0); ANCOVA NCT05190419 ↗

Publications

• Warren RB, Weiss A, Felding J, Sommer MOA, Garcet S, Krueger JG. Orismilast, a Potent and Selective PDE4B/D Inhibitor, Reduces Protein Levels of Key Disease Driving Cytokines in the Skin of Patients With Plaque Psoriasis. Exp Dermatol. 2025 Sep;34(9):e70153. doi: 10.1111/exd.70153.

Drugs

Indications