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Trial record 2 of 9 for:    M518101

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

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ClinicalTrials.gov Identifier: NCT01989429
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : December 31, 2015
Sponsor:
Collaborator:
Maruho Co., Ltd.
Information provided by (Responsible Party):
Maruho Europe Limited

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.


Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: M518101 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 788 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Vitamin D

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




Primary Outcome Measures :
  1. Severity of psoriasis [ Time Frame: 8 weeks ]
    % reduction in mPASI(modified psoriasis area and severity index) will be measured


Secondary Outcome Measures :
  1. Duration of response following 8 week treatment [ Time Frame: 8 weeks ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989429


Locations
Austria
Universitätsklinik für Dermatologie und Venerologie,
Graz, Austria, 8036
Bulgaria
DCC "Chaika" EOOD
Varna, Bulgaria, 9002
Germany
Universitatsklinikum Schleswig-Holstein
Lubeck, Germany, 23538
Hungary
Semmelweis Hospital
Miskolc, Csabai Kapu 9-11,, Hungary, H-3529
Lithuania
PI Hospital of Lithuanian University of Health Sciences
Kaunas, Lithuania
Poland
CSK MON Wojskowego Instytutu Medycznego
Warsaw, Poland
Sponsors and Collaborators
Maruho Europe Limited
Maruho Co., Ltd.
Investigators
Principal Investigator: D Thaci, Prof.Dr University of Lubeck, Dermatology Department

Responsible Party: Maruho Europe Limited
ClinicalTrials.gov Identifier: NCT01989429     History of Changes
Other Study ID Numbers: M518101-EU04
2013‐001632‐21 ( EudraCT Number )
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Maruho Europe Limited:
psoriasis
Vitamin D3
topical
ointments

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents