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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: M518101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, Vitamin D3, topical, ointments