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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989429
• Other study ID #: M518101-EU04
• Secondary ID: 2013-001632-21
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2013
• Last updated: December 1, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Maruho Europe Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesLithuania: State Medicine Control Agency - Ministry of HealthHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUkraine: Ministry of HealthBulgaria: Ministry of HealthRomania: National Medicines AgencyAustria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 788
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• M518101
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Maruho Europe Limited	Maruho Co., Ltd.

Countries where clinical trial is conducted

Austria,  Bulgaria,  Germany,  Hungary,  Lithuania,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of psoriasis	% reduction in mPASI(modified psoriasis area and severity index) will be measured	8 weeks	No
Secondary	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	No