NCT05919082

A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.

Detailed description

This study is phase 3, randomised, prospective, investigator-blinded, active-controlled, parallel group, multicentre trial to evaluate the efficacy and safety of 4 weeks treatment with LEO 90100 compared with Daivobet® ointment. Eligible participants will be randomised in a 1:1 ratio to either LEO 90100 or Daivobet® ointment treatment. The trial will last for 6 weeks to 10 weeks for each participant, which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks.

Conditions

• Stable Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	LEO 90100	Subjects will apply LEO 90100 topically; up to 15 g per day (or 105 g per week).
DRUG	Daivobet® ointment	Subjects will apply Daivobet® ointment topically; up to 15 g per day (or 105 g per week).

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-02-23
• Completion: 2024-03-05
• First posted: 2023-06-26
• Last updated: 2026-04-06
• Results posted: 2025-03-21

Locations

38 sites across 1 country: China