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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01301157
First received: February 18, 2011
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: M518101
Drug: placebo
Drug: Dovonex
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Maruho Co., Ltd.:

Primary Outcome Measures:
  • severity of plaque psoriasis [ Time Frame: 8 weeks after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator global assessment [ Time Frame: 8 weeks after dosing ] [ Designated as safety issue: No ]

Enrollment: 294
Study Start Date: February 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25ug M518101 Drug: M518101
Proper quantity twice a day
Placebo Comparator: Vehicle Drug: placebo
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301157

  Show 32 Study Locations
Sponsors and Collaborators
Maruho Co., Ltd.
  More Information

No publications provided

Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT01301157     History of Changes
Other Study ID Numbers: M518101-US01
Study First Received: February 18, 2011
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014