Clinical trial NCT03358290: Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Plaque Psoriasis
Skin Diseases
Keywords: JTE-051
Psoriasis
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
* 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:

* Medical history of treatment failure to any systemic agents for plaque psoriasis;
* 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);

Primary outcomes:
measure: Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: Percent Change From Baseline in PASI Score
timeFrame: Week 12
measure: Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)
timeFrame: Week 12
measure: Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)
timeFrame: Week 12
measure: Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)
timeFrame: Week 12
measure: Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1
timeFrame: Week 12
measure: Change From Baseline in Static Physician's Global Assessment (sPGA) Score
timeFrame: Week 12
measure: Percent Change From Baseline in Psoriasis Body Surface Area (BSA)
timeFrame: Week 12
measure: Change From Baseline in the Skindex-16 Overall Score
timeFrame: Week 12
measure: Change From Baseline in the Skindex-16 Symptoms Scale Score
timeFrame: Week 12
measure: Change From Baseline in the Skindex-16 Emotions Scale Score
timeFrame: Week 12
measure: Change From Baseline in the Skindex-16 Functioning Scale Score
timeFrame: Week 12
measure: Number of Subjects With Treatment-emergent Adverse Events
timeFrame: Up to 16 Weeks
measure: JTE-051 Trough Plasma Concentrations
timeFrame: Week 12
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center For Dermatology Clinical Research, Inc.
state: California
city: Tampa
country: United States
facility: University of South Florida - Hospital
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology Vein and Research Center LLC
state: Georgia
city: Sandy Springs
country: United States
facility: Advanced Medical Research, PC
state: Georgia
city: Nampa
country: United States
facility: Advanced Clinical Research - Dermatology Center of Canyon County
state: Idaho
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc.
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology P.A.
state: Kansas
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Saint John's
country: Canada
facility: Karma Clinical Trials
state: Newfoundland and Labrador
city: London
country: Canada
facility: Mediprobe Research Inc.
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: David Gratton's Private Practice
state: Quebec
Study officials:
References: