Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05268016
Last Updated: 2024-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2022-03-24
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ME3183 Dose 1, BID
Specified dose of ME3183 capsule for 16 weeks
ME3183
ME3183 capsule
ME3183 Dose 2, QD
Specified dose of ME3183 capsule for 16 weeks
ME3183
ME3183 capsule
ME3183 Dose 3, BID
Specified dose of ME3183 capsule for 16 weeks
ME3183
ME3183 capsule
ME3183 Dose 4, QD
Specified dose of ME3183 capsule for 16 weeks
ME3183
ME3183 capsule
Placebo
Placebo capsule of ME3183 for 16 weeks
Placebo
Placebo capsule
Interventions
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ME3183
ME3183 capsule
Placebo
Placebo capsule
Eligibility Criteria
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Inclusion Criteria
* Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Exclusion Criteria
* Active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening.
* Hepatitis B surface antigen positive at Screening.
* History of HIV or Positive for the HIV antibodies at Screening.
* History of allergy to any component of the study treatment.
* Active tuberculosis (TB) or a history of incompletely treated TB.
* Active infection (bacteria, viral, fungal, etc.) requiring treatment with systemic antibiotics within 4 weeks of Screening.
* Malignancy or history of malignancy except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and treated \[ie, cured\] cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence.
* Pregnant or breast feeding
* Received ustekinumab, secukinumab, brodalumab, ixekizumab, guselkumab, risankizumab, tildrakizumab, or briakinumab within 24 weeks of first administration of study treatment.
* Received TNF-α inhibitor(s)/blocker(s) within 8 weeks of first administration of study treatment.
* Received rituximab within 24 weeks of first administration of study treatment.
* Received phototherapy or any systemic medications/treatments within 4 weeks of the first administration of study treatment.
18 Years
75 Years
ALL
No
Sponsors
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Meiji Pharma USA Inc.
INDUSTRY
Responsible Party
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Locations
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Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
University of Southern California
Los Angeles, California, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, United States
International Dermatology Research, INC
Miami, Florida, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, United States
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
Lake Charles, Louisiana, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Studies in Dermatology, LLC
Cypress, Texas, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Center for Clinical Studies LTD, LLP
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada
SKiN Health
Cobourg, Ontario, Canada
Sudbury Skin Clinique
Greater Sudbury, Ontario, Canada
Dermatrials Research Inc.
Hamilton, Ontario, Canada
DermEffects
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Toronto Research Centre
Toronto, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Dr. David Gratton Dermatologue Inc.
Montreal, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ME3183-3
Identifier Type: -
Identifier Source: org_study_id
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