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Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis

NCT01908595•Maruho North America Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (31)

Agave Clinical Research

Mesa, Arizona, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Medical Center for Clinical Research

San Diego, California, United States

ATS Clinical Research

Santa Monica, California, United States

Horizons Clinical Research Center

Denver, Colorado, United States

Dermatology and Aesthetic Center Skin Care

Boca Raton, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

FXM Research Miramar

Miramar, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

May 1, 2015

Completion Date

May 1, 2015

Last Updated

September 2, 2015

Enrollment

480

ACTUAL participants

Conditions

Psoriasis

Interventions

M518101

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments