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

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Efficacy and Safety of ME3183 Administered Orally in Subjects With Moderate to Severe Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: ME3183

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5J 3S9
      • Laser Rejuvenation Clinics Edmonton D.T. Inc
  • Ontario
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Skin Health
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Dermatrials Research Inc.
    • London, Ontario, Canada, N6H 5L5
      • Dermeffects
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc.
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Sudbury, Ontario, Canada, P3A 1W8
      • Sudbury Skin Clinique
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
      • Dr. David Gratton Dermatologue Inc.
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Northwest Arkansas Clinical Trials Center
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc.
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research, INC
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Dermatology Associates
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Shondra L. Smith, MD Dermatology & Advanced Aesthetics
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Cypress, Texas, United States, 77433
      • Studies in Dermatology, LLC
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies LTD, LLP
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ME3183 Dose 1, BID; Specified dose of ME3183 capsule for 16 weeks	Drug: ME3183; ME3183 capsule
Experimental: ME3183 Dose 2, QD; Specified dose of ME3183 capsule for 16 weeks	Drug: ME3183; ME3183 capsule
Experimental: ME3183 Dose 3, BID; Specified dose of ME3183 capsule for 16 weeks	Drug: ME3183; ME3183 capsule
Experimental: ME3183 Dose 4, QD; Specified dose of ME3183 capsule for 16 weeks	Drug: ME3183; ME3183 capsule
Placebo Comparator: Placebo; Placebo capsule of ME3183 for 16 weeks	Drug: Placebo; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving 75% improvement in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16 from Baseline	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change from Baseline in PASI score at all visits from Week 1 to Week 16	Baseline to Week 16
Proportion of subjects achieving PASI-50, PASI-75, PASI-90, PASI-100 at all visits from Week 1 to Week 16	Baseline to Week 16
Time to PASI-50 and PASI-75	Baseline to Week 16
Proportion of subjects achieving a Static Physicians Global Assessment (sPGA) score of "0" ("clear") or "1" ("almost clear") combined with 2-point reduction on the 5-point sPGA scale at all visits from Week 1 to Week 16	Baseline to Week 16
Change from Baseline in affected Body Surface Area (BSA) at all visits from Week 1 to Week 16	Baseline to Week 16
Change from Baseline in the Itch Numerical Rating Scale (NRS) at all visits from Week 1 to Week 16	Baseline to Week 16
Percentage of subjects with at least a 5-point reduction from Baseline in the Dermatology Life Quality Index (DLQI) score at all visits from Week 1 to Week 16	Baseline to Week 16
The incidence, severity, and seriousness of adverse events (AEs) reported over the 16-week Treatment Period and the 4-week Follow-up Period	Baseline to Week 20

Collaborators and Investigators

• Sponsor: Meiji Pharma USA Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: ME3183-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No