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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: M518101

• Study Type: Interventional
• Enrollment (Actual): 788
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinik für Dermatologie und Venerologie,
• Bulgaria
  • Varna, Bulgaria, 9002
    • DCC "Chaika" EOOD
• Germany
  • Lubeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
• Hungary
  • Csabai Kapu 9-11,
    • Miskolc, Csabai Kapu 9-11,, Hungary, H-3529
      • Semmelweis Hospital
• Lithuania
  • Kaunas, Lithuania
    • PI Hospital of Lithuanian University of Health Sciences
• Poland
  • Warsaw, Poland
    • CSK MON Wojskowego Instytutu Medycznego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
• Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
• Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy

Exclusion Criteria:

• Pregnant or lactating females;
• Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
• Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
• Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
• Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
• Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
• Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
• Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Daivonex; topical application	Drug: M518101; 8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse; Other Names: vitamin D3; psoriasis treatment
Placebo Comparator: vehicle; topical application	Drug: M518101; 8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse; Other Names: vitamin D3; psoriasis treatment
Experimental: M518101; topical application	Drug: M518101; 8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse; Other Names: vitamin D3; psoriasis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of psoriasis	% reduction in mPASI(modified psoriasis area and severity index) will be measured	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response following 8 week treatment	if mPASI is reduced by 50% or more at V7 , patients will be followed up for a further 8 weeks to evaluate time to relapse	8 weeks

Collaborators and Investigators

• Sponsor: Maruho Europe Limited
• Collaborators: Maruho Co., Ltd.
• Investigators: Principal Investigator: D Thaci, Prof.Dr, University of Lubeck, Dermatology Department

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D3; topical; psoriasis; ointments
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: M518101-EU04; 2013-001632-21 (EudraCT Number)