Adults aged 18 to 75 years (inclusive) with a diagnosis of plaque psoriasis for 24 weeks or more, may qualify for this study. Qualified participants must also have moderate to severe disease with psoriatic plaques covering 10% or more body surface area. Individuals with a diagnosis of non-plaque psoriasis or drug-induced psoriasis, are not qualified for this study.
Participants will receive investigational oral medication (active study drug) or placebo. Study medication and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Study participation will last about 24 weeks and involve about 9 visits to the study centre.
The following information is from ClinicalTrials.gov
Last Update Posted: November 27, 2022
NCT05268016
Meiji Pharma USA Inc.
Brief Summary:
The purpose of this study is to assess the efficacy and safety of ME3183 administered orally for moderate to severe plaque psoriasis in adults.
Condition or Disease:
Plaque Psoriasis
Intervention/Treatment:
Drug: ME3183Phase:
Phase 2
Ages Eligible for Study:
18 Years and 75 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Male and female, ages 18 to 75 years
Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Exclusion Criteria:
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
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Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.
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