Phase 3Completed
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
- Sponsor
- Maruho Europe Limited (Industry)
- Enrolment
- 788 enrolled
- Conditions
- Plaque Psoriasis
- Interventions
- M518101
- Ages
- adults, older adults
- Registry
- NCT01989429, EUCTR2013-001632-21
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Severity of psoriasis
History
Last registry update
Primary completion
Registered
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