Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
NCT ID: NCT03358290
Last Updated: 2021-08-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
13 participants
INTERVENTIONAL
2017-11-10
2018-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JTE-051 Dose 1
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 2
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 3
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 4
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
Placebo
One dose of study drug by mouth daily for 12 weeks
Placebo
Placebo tablets identical in appearance to the active drug tablets
Interventions
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JTE-051
Active drug tablets containing JTE-051
Placebo
Placebo tablets identical in appearance to the active drug tablets
Eligibility Criteria
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Inclusion Criteria
* Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
* Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
* Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
* Body Mass Index (BMI) ≤40 at Visit 1.
Exclusion Criteria
* Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
* Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
* History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
* History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);
18 Years
70 Years
ALL
No
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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First OC Dermatology
Fountain Valley, California, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
University of South Florida - Hospital
Tampa, Florida, United States
Atlanta Dermatology Vein and Research Center LLC
Alpharetta, Georgia, United States
Advanced Medical Research, PC
Sandy Springs, Georgia, United States
Advanced Clinical Research - Dermatology Center of Canyon County
Nampa, Idaho, United States
Clinical Research Advantage, Inc.
Evansville, Indiana, United States
Kansas City Dermatology P.A.
Overland Park, Kansas, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
Radiant Research, Inc.
Anderson, South Carolina, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Karma Clinical Trials
St. John's, Newfoundland and Labrador, Canada
Mediprobe Research Inc.
London, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
David Gratton's Private Practice
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AE051-G-16-007
Identifier Type: -
Identifier Source: org_study_id
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