NCT01989429

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
788

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

October 28, 2013

Last Update Submit

December 1, 2015

Conditions

Plaque Psoriasis

Keywords

psoriasisVitamin D3topicalointments

Outcome Measures

Primary Outcomes (1)

  • Severity of psoriasis

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

    8 weeks

Secondary Outcomes (1)

  • Duration of response following 8 week treatment

    8 weeks

Study Arms (3)

Daivonex

ACTIVE COMPARATOR

topical application

Drug: M518101

vehicle

PLACEBO COMPARATOR

topical application

Drug: M518101

M518101

EXPERIMENTAL

topical application

Drug: M518101

Interventions

M518101DRUG

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

Also known as: vitamin D3, psoriasis treatment
DaivonexM518101vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitätsklinik für Dermatologie und Venerologie,

Graz, 8036, Austria

Location

DCC "Chaika" EOOD

Varna, 9002, Bulgaria

Location

Universitatsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Semmelweis Hospital

Miskolc, Csabai Kapu 9-11,, H-3529, Hungary

Location

PI Hospital of Lithuanian University of Health Sciences

Kaunas, Lithuania

Location

CSK MON Wojskowego Instytutu Medycznego

Warsaw, Poland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • D Thaci, Prof.Dr

    University of Lubeck, Dermatology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 21, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

HU(1)DE(1)BU(1)PL(1)AU(1)LI(1)