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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301157
First Posted: February 23, 2011
Last Update Posted: November 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maruho Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Investigator global assessment [ Time Frame: 8 weeks after dosing ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01301157


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

Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT01301157     History of Changes
Other Study ID Numbers: M518101-US01
First Submitted: February 18, 2011
First Posted: February 23, 2011
Last Update Posted: November 5, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcipotriene
Dermatologic Agents