Clinical trial NCT03018509: Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JTE-451 Administered for 4 Weeks in Subjects With Active Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque Psoriasis
Psoriasis
Skin Diseases
Keywords: JTE-451
psoriasis
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Minimum of two psoriatic plaques (i.e., one clinical target lesion and one biopsy target lesion).
* Each of the two target lesions must have a psoriatic lesion severity sum (PLSS) of ≥6
* Body mass index (BMI) of 18 to 38 kg/m2 (inclusive)

Exclusion Criteria:

* Prior exposure to \>2 systemic biologic agents and/or small molecules including investigational therapies for the treatment of psoriasis or have not discontinued systemic biologic agents and/or small molecules anti-psoriasis therapy including investigational therapies due to lack of efficacy;
* Subjects with significant health problems, other than having plaque psoriasis (as determined by medical history, physical examination, chest X-ray, vital signs and 12-lead ECG) that could either interfere with study evaluations or place subject at undue risk;
* Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis at Visit 1;
* Conditions (e.g., clinically-significant eczema or severe acne in the target lesion area) that would interfere with study evaluations;
* Positive quantiFERON®-TB Gold test, negative chest X-ray findings for tubercle bacillus (TB) or lack any other evidence of active or latent TB;
* History of a clinically-significant infection (e.g., required oral antimicrobial therapy) within 4 weeks prior to Visit 2;
* Subjects who do not have clinical laboratory test results within the normal reference ranges (i.e., are deemed not to be clinically significant) or clinically not acceptable to the Investigator;

Primary outcomes:
measure: Number of adverse events
timeFrame: 4 weeks
measure: Percent change from baseline in the clinical target PLSS
timeFrame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion erythema
timeFrame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion induration
timeFrame: Weeks 1, 2, 3 and 4
measure: Percent change from baseline in the clinical target lesion scaling
timeFrame: Weeks 1, 2, 3 and 4
measure: Change from baseline in the clinical target lesion sPGA score
timeFrame: Weeks 1, 2, 3 and 4
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
timeFrame: Week 1
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
timeFrame: Week 2
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
timeFrame: Week 3
measure: Number of subjects with clinical target lesion sPGA scores of 0 or 1
timeFrame: Week 4
measure: Number of subjects with at least a 2-point improvement in sPGA score
timeFrame: Baseline to Week 4
measure: Trough concentration during multiple dosing prior to next dose (Ctrough)
timeFrame: Weeks 1, 2, 3 and 4
Secondary outcomes:
Other outcomes:
Locations:
city: Surrey
country: Canada
state: British Columbia
city: Markham
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
Study officials:
References: