Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

132

Study ID:

NCT05268016

Recruitment Status:

Completed

Sponsor:

Meiji Pharma USA Inc.

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There are 27 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

132

Study ID:

NCT05268016

Recruitment Status:

Completed

Sponsor:


Meiji Pharma USA Inc.

How clear is this clinincal trial information?

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