Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.

Key facts

Study ID

NCT05268016

Run by

Meiji Pharma USA Inc.

People needed

132

Starts

2022-03-24

Expected to finish

2023-05-31

Last updated by the study team

2024-06-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female, ages 18 to 75 years
• Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.

You may not qualify if…

• Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
• 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.
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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