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

Phase 3

Completed

• Conditions: Psoriasis
• Interventions: Drug: M518101; Drug: Vehicle

• Registration Number: NCT01873677
• Lead Sponsor: Maruho North America Inc.

Brief Summary

This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Disposition First Submitted: 2015-08-14
• Disposition First Submitted QC: 2015-08-14
• Last Update Submitted: 2015-08-14
• Disposition First Posted: 2015-09-02
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 537

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 randomization.
• Who have been treated with systemic therapy within 30days of randomization.
• Who have treated with biologics within 5 half-lives of the biologics before the day of randomization
• Who have been treated with topical therapy within 14days before the day of randomization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M518101	M518101	Proper quantity twice a day
Vehicle	Vehicle	Proper quantity twice a day

Primary Outcome Measures

Name	Time	Method
Investigator Global Assessment	8 weeks after dosing

Trial Locations

Locations (30)

Coastal Clinical Research; 🇺🇸 Mobile, Alabama, United States

Omni Dermatology; 🇺🇸 Phoenix, Arizona, United States

Skin Surgery Medical Group; 🇺🇸 San Diego, California, United States

University Clinical Trials; 🇺🇸 San Diego, California, United States

The Savin Center; 🇺🇸 New Haven, Connecticut, United States

Visions Clinical Research; 🇺🇸 Boynton Beach, Florida, United States

North Florida Dermatology Associates; 🇺🇸 Jacksonville, Florida, United States

International Dermatology Research Inc; 🇺🇸 Miami, Florida, United States

FXM Research Miramar; 🇺🇸 Miramar, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

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