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

NCT05268016 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ME3183-3
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 27

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI score. The final PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Missing PASI at Week 16 are imputed as non-responders via NRI.

  Week 16

Secondary Outcomes (19)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Over the 16-week Treatment Period and the 4-week Follow-up Period

  Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)

• Number of Participants With Serious TEAEs Over the 16-week Treatment Period and the 4-week Follow-up Period

  Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)

• Number of Participants With TEAEs by Severity Over the 16-week Treatment Period and the 4-week Follow-up Period

  Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)

• Number of Participants With Clinically Significant Abnormalities in Physical Examination

  Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)

• Number of Participants With Clinically Significant Abnormalities in Vital Signs

  Over the 16-week Treatment Period and the 4-week Follow-up Period (up to Week 20)

Study Arms (5)

ME3183 Dose 1, BID

EXPERIMENTAL

Specified dose of ME3183 capsule for 16 weeks

Drug: ME3183

ME3183 Dose 2, QD

EXPERIMENTAL

Specified dose of ME3183 capsule for 16 weeks

Drug: ME3183

ME3183 Dose 3, BID

EXPERIMENTAL

Specified dose of ME3183 capsule for 16 weeks

Drug: ME3183

ME3183 Dose 4, QD

EXPERIMENTAL

Specified dose of ME3183 capsule for 16 weeks

Drug: ME3183

Placebo

PLACEBO COMPARATOR

Placebo capsule of ME3183 for 16 weeks

Drug: Placebo

Interventions

ME3183 DRUG

ME3183 capsule

ME3183 Dose 1, BID; ME3183 Dose 2, QD; ME3183 Dose 3, BID; ME3183 Dose 4, QD

Placebo DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, ages 18 to 75 years
• Participant with stable moderate to severe chronic plaque psoriasis of at least 24 weeks duration.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meiji Pharma USA Inc.: lead

Study Sites (27)

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80210, United States

Location

International Dermatology Research, INC

Miami, Florida, 33144, United States

Location

Qualmedica Research, LLC

Evansville, Indiana, 47715, United States

Location

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303, United States

Location

Shondra L. Smith, MD Dermatology & Advanced Aesthetics

Lake Charles, Louisiana, 70605, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Studies in Dermatology, LLC

Cypress, Texas, 77433, United States

Location

Dermatology Treatment and Research Center

Dallas, Texas, 75230, United States

Location

Center for Clinical Studies LTD, LLP

Houston, Texas, 77004, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Premier Clinical Research

Spokane, Washington, 99202, United States

Location

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, T5J 3S9, Canada

Location

SKiN Health

Cobourg, Ontario, K9A 0Z4, Canada

Location

Sudbury Skin Clinique

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

Dermatrials Research Inc.

Hamilton, Ontario, L8N 1Y2, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge Research

Mississauga, Ontario, L4Y 4C5, Canada

Location

Dermatology Ottawa Research Centre

Ottawa, Ontario, K2C 3N2, Canada

Location

The Centre for Dermatology

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Toronto Research Centre

Toronto, Ontario, M3H 5Y8, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

Dr. David Gratton Dermatologue Inc.

Montreal, Quebec, H3H 1V4, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Results Point of Contact

• Title: Meiji Pharma USA Inc. Study Lead
• Organization: Meiji Pharma USA Inc.

mpu.contact@meiji.com

+1 201-777-7133

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: March 24, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 27, 2024
• Results First Posted: June 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13); US (14)