Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients

This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: M518101; Drug: placebo; Drug: Dovonex

Detailed Description

This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama (UAB) Dermatology
    • Mobile, Alabama, United States, 36608
      • Coastal Carolina Research
  • California
    • Fresno, California, United States, 93710
      • Sierra Medical Research
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • Santa Monica,, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Visions Clinical Research
    • Jacsonville, Florida, United States, 32216
      • Ameriderm Research
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Ctr
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Northshore University Healthsystem
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
    • South Bend, Indiana, United States, 46617
      • The Southbend Clinic, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Derm Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Medical Development Centers, LLC
    • Opelousas, Louisiana, United States, 70570
      • Medical Development Centers, LLC
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Washington University, Dermatology Clinical Trials Unit
    • St. Louis, Missouri, United States, 63117
      • Central Dermatology
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center, Section of Dermatology
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
    • Stony Brook, New York, United States, 11790
      • DermResearchCenter of New York, Inc
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
    • Wilmington, North Carolina, United States, 28403
      • Wilmington Dermatology Center
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Radiant Research
  • Oklahoma
    • Oklahoma, Oklahoma, United States, 73104
      • OUHSC-Dermatology
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Baker Allergy, Asthma and Dermatology Research Center, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc
    • Houston, Texas, United States, 77030
      • Center for Clinical Studies, Texas Medical Center
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research Inc.
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Who are able and willing to give signed informed consent
2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
3. Who have less than 20% of body surface area (BSA) afflicted with plaques
4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

1. Who have a history of allergy to vitamin D3 derivative preparations.
2. Who have a history of relevant drug hypersensitivity.
3. Who have a history of contact dermatitis induced by a topical medicine.
4. Who are pregnant or lactating.
5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7. Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
8. Whose serum calcium levels exceed the upper limit of reference range
9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
12. Who have been treated with topical therapy during the wash-out period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: placebo; Proper quantity twice a day
Experimental: 25ug M518101	Drug: M518101; Proper quantity twice a day
Active Comparator: Dovonex	Drug: Dovonex; Proper quantity twice a day
Experimental: 50ug M518101	Drug: M518101; Proper quantity twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
severity of plaque psoriasis	8 weeks after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigator global assessment	8 weeks after dosing

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 18, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: October 12, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: M518101-US01