Psoriasis Clinical Trial
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
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.
Eligibility Criteria
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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There are 27 Locations for this study
Rogers Arkansas, 72758, United States
Los Angeles California, 90033, United States
Denver Colorado, 80210, United States
Miami Florida, 33144, United States
Evansville Indiana, 47715, United States
Owensboro Kentucky, 42303, United States
Lake Charles Louisiana, 70605, United States
Rochester New York, 14623, United States
Nashville Tennessee, 37215, United States
Cypress Texas, 77433, United States
Dallas Texas, 75230, United States
Houston Texas, 77004, United States
San Antonio Texas, 78229, United States
Spokane Washington, 99202, United States
Edmonton Alberta, T5J 3, Canada
Cobourg Ontario, K9A 0, Canada
Hamilton Ontario, L8N 1, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Mississauga Ontario, L4Y 4, Canada
Ottawa Ontario, K2C 3, Canada
Richmond Hill Ontario, L4B 1, Canada
Sudbury Ontario, P3A 1, Canada
Toronto Ontario, M3H 5, Canada
Waterloo Ontario, N2J 1, Canada
Montreal Quebec, H3H 1, Canada
Saskatoon Saskatchewan, S7K 2, Canada
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