Clinical trial NCT01989429: Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: psoriasis
Vitamin D3
topical
ointments
Lead sponsor: Maruho Europe Limited
Sponsor class: INDUSTRY
Collaborators: name: Maruho Co., Ltd.
First posted: 2013-11-21
Enrollment: 788
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of psoriasis
timeFrame: 8 weeks
Secondary outcomes:
measure: Duration of response following 8 week treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Dermatologie und Venerologie,
city: Varna
country: Bulgaria
facility: DCC "Chaika" EOOD
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Miskolc
country: Hungary
facility: Semmelweis Hospital
state: Csabai Kapu 9-11,
city: Kaunas
country: Lithuania
facility: PI Hospital of Lithuanian University of Health Sciences
city: Warsaw
country: Poland
facility: CSK MON Wojskowego Instytutu Medycznego
Study officials:
affiliation: University of Lubeck, Dermatology Department
name: D Thaci, Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References: