orismilast

Evidence outlook · lead readout

NCT05469464 · Atopic Dermatitis, Skin Diseases

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

NCT05469464: This randomized, quadruple-blind, placebo-controlled Phase 2 trial compared three orismilast doses with placebo in 233 adults with moderate-to-severe atopic dermatitis. The primary endpoint, percent change from baseline in EASI at Week 16, was not met: the drug-placebo differences were -4.6, -1.7, and -10.9 percentage points with p-values of 0.505, 0.812, and 0.118. Because a well-designed trial with a non-significant primary endpoint cannot be considered strong evidence, the study provides only moderate evidence for orismilast despite its otherwise robust design.

Also in development:Psoriasis · Phase 2