Status:
COMPLETED
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Meiji Pharma USA Inc.
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Male and female, ages 18 to 75 years
- Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.
Exclusion
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT05268016
Start Date
March 24 2022
End Date
May 31 2023
Last Update
June 27 2024
Active Locations (27)
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1
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States, 72758
2
University of Southern California
Los Angeles, California, United States, 90033
3
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80210
4
International Dermatology Research, INC
Miami, Florida, United States, 33144