Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects
Phase 1
Completed
- Conditions
- Plaque PsoriasisPsoriasisSkin Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT03018509
- Lead Sponsor
- Akros Pharma Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JTE-451 Dose 2 JTE-451 JTE-451 dose 2 for 28 days JTE-451 Dose 1 JTE-451 JTE-451 dose 1 for 28 days JTE-451 Dose 3 JTE-451 JTE-451 dose 3 for 28 days JTE-451 Dose 4 JTE-451 JTE-451 dose 4 for 28 days Placebo Placebo Placebo for 28 days
- Primary Outcome Measures
Name Time Method Number of subjects with clinical target lesion sPGA scores of 0 or 1 Week 4 Number of subjects with at least a 2-point improvement in sPGA score Baseline to Week 4 Trough concentration during multiple dosing prior to next dose (Ctrough) Weeks 1, 2, 3 and 4 Number of adverse events 4 weeks Percent change from baseline in the clinical target lesion erythema Weeks 1, 2, 3 and 4 Percent change from baseline in the clinical target lesion induration Weeks 1, 2, 3 and 4 Percent change from baseline in the clinical target lesion scaling Weeks 1, 2, 3 and 4 Change from baseline in the clinical target lesion sPGA score Weeks 1, 2, 3 and 4 Percent change from baseline in the clinical target PLSS Weeks 1, 2, 3 and 4
- Secondary Outcome Measures
Name Time Method