Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)
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.
Timeline
- Start
- 2022-07-11
- Primary completion
- 2024-01-23
- Completion
- 2024-02-15
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Orismilast Modified Release Tablets 40 mg BID vs Placebo Tablets BID; p = 0.118; Mean Difference (Net) -10.9 (95% CI -24.6 to 2.8); ANCOVA reads as missed primary endpoint NCT05469464 ↗
release “Orismilast demonstrated clear treatment effect with statistical significance for all dose arms on the registrational endpoint of IGA0/1 at week 16” reads as met primary endpoint uniontherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEO 32731 | Unknown | 20 mg | Oral |
| Subject | LEO 32731 | Unknown | 30 mg | Oral |
| Subject | LEO 32731 | Unknown | 40 mg | Oral |