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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268016
• Other study ID #: ME3183-3
• Status: Completed
• Phase: Phase 2
• Start date: March 24, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2024
• Source: Meiji Pharma USA Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-a 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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• ME3183
ME3183 capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
Canada	SKiN Health	Cobourg	Ontario
Canada	Laser Rejuvenation Clinics Edmonton D.T. Inc	Edmonton	Alberta
Canada	Dermatrials Research Inc.	Hamilton	Ontario
Canada	DermEffects	London	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	DermEdge Research	Mississauga	Ontario
Canada	Dr. David Gratton Dermatologue Inc.	Montreal	Quebec
Canada	Dermatology Ottawa Research Centre	Ottawa	Ontario
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	Skinsense Medical Research	Saskatoon	Saskatchewan
Canada	Sudbury Skin Clinique	Sudbury	Ontario
Canada	Toronto Research Centre	Toronto	Ontario
Canada	K. Papp Clinical Research	Waterloo	Ontario
United States	Studies in Dermatology, LLC	Cypress	Texas
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Qualmedica Research, LLC	Evansville	Indiana
United States	Center for Clinical Studies LTD, LLP	Houston	Texas
United States	Shondra L. Smith, MD Dermatology & Advanced Aesthetics	Lake Charles	Louisiana
United States	University of Southern California	Los Angeles	California
United States	International Dermatology Research, INC	Miami	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Owensboro Dermatology Associates	Owensboro	Kentucky
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Northwest Arkansas Clinical Trials Center	Rogers	Arkansas
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Pharma USA Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent change from Baseline in PASI score at all visits from Week 1 to Week 16		Baseline to Week 16
Secondary	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
Secondary	Time to PASI-50 and PASI-75		Baseline to Week 16
Secondary	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
Secondary	Change from Baseline in affected Body Surface Area (BSA) at all visits from Week 1 to Week 16		Baseline to Week 16
Secondary	Change from Baseline in the Itch Numerical Rating Scale (NRS) at all visits from Week 1 to Week 16		Baseline to Week 16
Secondary	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
Secondary	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