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

• Status: Not yet recruiting
• Trial end date: 2023-07-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meiji Pharma USA Inc.

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