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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ME3183
Placebo
Sponsored by
Meiji Pharma USA Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwest Arkansas Clinical Trials Center
  • University of Southern California
  • Colorado Medical Research Center, Inc.
  • International Dermatology Research, INC
  • Qualmedica Research, LLC
  • Owensboro Dermatology Associates
  • Shondra L. Smith, MD Dermatology & Advanced Aesthetics
  • Skin Search of Rochester, Inc.
  • Tennessee Clinical Research Center
  • Studies in Dermatology, LLC
  • Dermatology Treatment and Research Center
  • Center for Clinical Studies LTD, LLP
  • Dermatology Clinical Research Center of San Antonio
  • Premier Clinical Research
  • Laser Rejuvenation Clinics Edmonton D.T. Inc
  • SKiN Health
  • Dermatrials Research Inc.
  • DermEffects
  • Lynderm Research Inc.
  • DermEdge Research
  • Dermatology Ottawa Research Centre
  • The Centre for Dermatology
  • Sudbury Skin Clinique
  • Toronto Research Centre
  • K. Papp Clinical Research
  • Dr. David Gratton Dermatologue Inc.
  • Skinsense Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ME3183 Dose 1, BID

ME3183 Dose 2, QD

ME3183 Dose 3, BID

ME3183 Dose 4, QD

Placebo

Arm Description

Specified dose of ME3183 capsule for 16 weeks

Specified dose of ME3183 capsule for 16 weeks

Specified dose of ME3183 capsule for 16 weeks

Specified dose of ME3183 capsule for 16 weeks

Placebo capsule of ME3183 for 16 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent change from Baseline in PASI score at all visits from Week 1 to Week 16
Proportion of subjects achieving PASI-50, PASI-75, PASI-90, PASI-100 at all visits from Week 1 to Week 16
Time to PASI-50 and PASI-75
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
Change from Baseline in affected Body Surface Area (BSA) at all visits from Week 1 to Week 16
Change from Baseline in the Itch Numerical Rating Scale (NRS) at all visits from Week 1 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
The incidence, severity, and seriousness of adverse events (AEs) reported over the 16-week Treatment Period and the 4-week Follow-up Period

Full Information

First Posted
February 24, 2022
Last Updated
June 5, 2023
Sponsor
Meiji Pharma USA Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05268016
Brief Title
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meiji Pharma USA Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ME3183 Dose 1, BID
Arm Type
Experimental
Arm Description
Specified dose of ME3183 capsule for 16 weeks
Arm Title
ME3183 Dose 2, QD
Arm Type
Experimental
Arm Description
Specified dose of ME3183 capsule for 16 weeks
Arm Title
ME3183 Dose 3, BID
Arm Type
Experimental
Arm Description
Specified dose of ME3183 capsule for 16 weeks
Arm Title
ME3183 Dose 4, QD
Arm Type
Experimental
Arm Description
Specified dose of ME3183 capsule for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule of ME3183 for 16 weeks
Intervention Type
Drug
Intervention Name(s)
ME3183
Intervention Description
ME3183 capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Primary Outcome Measure Information:
Title
Proportion of subjects achieving 75% improvement in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16 from Baseline
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percent change from Baseline in PASI score at all visits from Week 1 to Week 16
Time Frame
Baseline to Week 16
Title
Proportion of subjects achieving PASI-50, PASI-75, PASI-90, PASI-100 at all visits from Week 1 to Week 16
Time Frame
Baseline to Week 16
Title
Time to PASI-50 and PASI-75
Time Frame
Baseline to Week 16
Title
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
Time Frame
Baseline to Week 16
Title
Change from Baseline in affected Body Surface Area (BSA) at all visits from Week 1 to Week 16
Time Frame
Baseline to Week 16
Title
Change from Baseline in the Itch Numerical Rating Scale (NRS) at all visits from Week 1 to Week 16
Time Frame
Baseline to Week 16
Title
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
Time Frame
Baseline to Week 16
Title
The incidence, severity, and seriousness of adverse events (AEs) reported over the 16-week Treatment Period and the 4-week Follow-up Period
Time Frame
Baseline to Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northwest Arkansas Clinical Trials Center
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Colorado Medical Research Center, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
International Dermatology Research, INC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Qualmedica Research, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Owensboro Dermatology Associates
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Shondra L. Smith, MD Dermatology & Advanced Aesthetics
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Studies in Dermatology, LLC
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Center for Clinical Studies LTD, LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Laser Rejuvenation Clinics Edmonton D.T. Inc
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Facility Name
SKiN Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Facility Name
Dermatrials Research Inc.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Facility Name
Dermatology Ottawa Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Facility Name
The Centre for Dermatology
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
Sudbury Skin Clinique
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Dr. David Gratton Dermatologue Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Skinsense Medical Research
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 2C1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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