Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of
JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
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Locations near you
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Full eligibility criteria for NCT03018509
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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)
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;
All locations for NCT03018509
Surrey, British Columbia, Canada
Markham, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Waterloo, Ontario, Canada
British Columbia (1)
Surrey, British Columbia, Canada
View full eligibility
Tris trial is registered with FDA with number: NCT03018509. The sponsor of the trial is Akros Pharma Inc. and it is looking for 47 volunteers for the current phase.
Official trial 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
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