Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects

NCT ID: NCT03018509

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-06-20

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.

Conditions

Plaque Psoriasis; Psoriasis; Skin Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JTE-451 Dose 1

JTE-451 dose 1 for 28 days

Group Type: EXPERIMENTAL

JTE-451

Intervention Type: DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 2

JTE-451 dose 2 for 28 days

Group Type: EXPERIMENTAL

JTE-451

Intervention Type: DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 3

JTE-451 dose 3 for 28 days

Group Type: EXPERIMENTAL

JTE-451

Intervention Type: DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 4

JTE-451 dose 4 for 28 days

Group Type: EXPERIMENTAL

JTE-451

Intervention Type: DRUG

Active drug tablets containing JTE-451

Placebo

Placebo for 28 days

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo tablets identical in appearance to the active drug tablets

Interventions

JTE-451

Active drug tablets containing JTE-451

Intervention Type: DRUG

Placebo

Placebo tablets identical in appearance to the active drug tablets

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akros Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Surrey, British Columbia, Canada

Markham, Ontario, Canada

Peterborough, Ontario, Canada

Richmond Hill, Ontario, Canada

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

AE451-X-16-003

Identifier Type: -

Identifier Source: org_study_id