Clinical trial NCT05268016: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Meiji Pharma USA Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants Achieving Greater Than or Equal to (>=) 75% Reduction From Baseline in Psoriasis Area Severity Index (PASI) Score (PASI-75) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examination
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Tests
timeFrame: Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)
measure: Percent Change From Baseline in PASI Score at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving >=50% Reduction From Baseline in the PASI Score (PASI-50) at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving >=75% Reduction From Baseline in the PASI Score (PASI-75) at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving >=90% Reduction From Baseline in the PASI Score (PASI-90) at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants Achieving 100% Reduction From Baseline in the PASI Score (PASI-100) at All Visits From Week 1 to Week 16
timeFrame: Baseline, 1, 2, 4, 8, 12 and 16
measure: Time to PASI-50
timeFrame: Baseline to Week 16
measure: Time to PASI-75
timeFrame: Baseline to Week 16
measure: Percentage of Participants 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
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in Affected Body Surface Area (BSA) at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in the Itch Numerical Rating Scale (NRS) at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Percentage of Participants With at Least a 5-point Reduction From Baseline in the DLQI Score at All Visits From Week 1 to Week 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12 and 16
measure: Trough Serum Concentration (Ctrough) of ME3183
timeFrame: Pre-dose at Week 1, 4, 8 and 16
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Miami
country: United States
facility: International Dermatology Research, INC
state: Florida
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Lake Charles
country: United States
facility: Shondra L. Smith, MD Dermatology & Advanced Aesthetics
state: Louisiana
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Cypress
country: United States
facility: Studies in Dermatology, LLC
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies LTD, LLP
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Edmonton
country: Canada
facility: Laser Rejuvenation Clinics Edmonton D.T. Inc
state: Alberta
city: Cobourg
country: Canada
facility: SKiN Health
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research Inc.
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Sudbury
country: Canada
facility: Sudbury Skin Clinique
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Dr. David Gratton Dermatologue Inc.
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
Study officials:
References: