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

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

M518101

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring psoriasis, Vitamin D3, topical, ointments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitätsklinik für Dermatologie und Venerologie,
DCC "Chaika" EOOD
Universitatsklinikum Schleswig-Holstein
Semmelweis Hospital
PI Hospital of Lithuanian University of Health Sciences
CSK MON Wojskowego Instytutu Medycznego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Daivonex

vehicle

M518101

Arm Description

topical application

Outcomes

Primary Outcome Measures

Severity of psoriasis

% reduction in mPASI(modified psoriasis area and severity index) will be measured

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01989429

First Posted

October 28, 2013

Last Updated

December 1, 2015

Sponsor

Maruho Europe Limited

Collaborators

Maruho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01989429

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maruho Europe Limited

Collaborators

Maruho Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

psoriasis, Vitamin D3, topical, ointments

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

788 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daivonex

Arm Type

Active Comparator

Arm Description

topical application

Arm Title

vehicle

Arm Type

Placebo Comparator

Arm Description

topical application

Arm Title

M518101

Arm Type

Experimental

Arm Description

topical application

Intervention Type

Drug

Intervention Name(s)

M518101

Other Intervention Name(s)

vitamin D3, psoriasis treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Severity of psoriasis

Description

% reduction in mPASI(modified psoriasis area and severity index) will be measured

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Duration of response following 8 week treatment

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D Thaci, Prof.Dr

Organizational Affiliation

University of Lubeck, Dermatology Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinik für Dermatologie und Venerologie,

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

DCC "Chaika" EOOD

City

Varna

ZIP/Postal Code

9002

Country

Bulgaria

Facility Name

Universitatsklinikum Schleswig-Holstein

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Semmelweis Hospital

City

Miskolc

State/Province

Csabai Kapu 9-11,

ZIP/Postal Code

H-3529

Country

Hungary

Facility Name

PI Hospital of Lithuanian University of Health Sciences

City

Kaunas

Country

Lithuania

Facility Name

CSK MON Wojskowego Instytutu Medycznego

City

Warsaw

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

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

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