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Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01908595
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Maruho North America Inc.

Brief Summary:
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: M518101 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
Study Start Date : August 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: M518101
Proper quantity twice daily
Drug: M518101



Primary Outcome Measures :
  1. Time course change of Investigator Global Assessment [ Time Frame: 4 weeks interval ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
  • Who are pregnant or lactating.
  • Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
  • Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
  • 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.
  • Whose serum calcium levels exceed the upper limit of reference range
  • Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment.
  • Who have been treated with systemic therapy within 30days of treatment.
  • Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
  • Who have been treated with topical therapy within 14days before the day of treatment.

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): NCT01908595


  Show 31 Study Locations
Sponsors and Collaborators
Maruho North America Inc.

Responsible Party: Maruho North America Inc.
ClinicalTrials.gov Identifier: NCT01908595     History of Changes
Other Study ID Numbers: M518101-US04
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases