drugset / Trial / NCT01989429

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

NCT01989429

Phase 3 Completed 788 enrolled Maruho Europe Limited Maruho Co., Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-10
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject pefcalcitol Small molecule 50 unknown Topical

Indications