NCT01989429

Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients

A Randomized, Double-blind, Parallel Group Phase III Multi-center Trial to Compare Twice Daily Topical Application of M518101, Daivonex® and Vehicle in Patients With Plaque Psoriasis III

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 788 (actual)
• Sponsor: Maruho Europe Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101) Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis. Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	M518101	8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-11-21
• Last updated: 2015-12-31

Locations

6 sites across 6 countries: Austria, Bulgaria, Germany, Hungary, Lithuania, Poland