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

Meiji Seika Pharma

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: ME3183; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05268016

ME3183-3

Details and patient eligibility

About

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

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 5 patient groups, including a placebo group

ME3183 Dose 1, BID

Experimental group

Description:

Specified dose of ME3183 capsule for 16 weeks

Treatment:

Drug: ME3183

ME3183 Dose 2, QD

Experimental group

Description:

Specified dose of ME3183 capsule for 16 weeks

Treatment:

Drug: ME3183

ME3183 Dose 3, BID

Experimental group

Description:

Specified dose of ME3183 capsule for 16 weeks

Treatment:

Drug: ME3183

ME3183 Dose 4, QD

Experimental group

Description:

Specified dose of ME3183 capsule for 16 weeks

Treatment:

Drug: ME3183

Placebo

Placebo Comparator group

Description:

Placebo capsule of ME3183 for 16 weeks

Treatment:

Drug: Placebo