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

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

Study Overview

• Status: Completed
• Conditions: Skin Diseases; Psoriasis; Plaque Psoriasis
• Intervention / Treatment: Drug: JTE-451; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada
  • Ontario
    • Markham, Ontario, Canada
    • Peterborough, Ontario, Canada
    • Richmond Hill, Ontario, Canada
    • Waterloo, Ontario, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JTE-451 Dose 1; JTE-451 dose 1 for 28 days	Drug: JTE-451; Active drug tablets containing JTE-451
Experimental: JTE-451 Dose 2; JTE-451 dose 2 for 28 days	Drug: JTE-451; Active drug tablets containing JTE-451
Experimental: JTE-451 Dose 3; JTE-451 dose 3 for 28 days	Drug: JTE-451; Active drug tablets containing JTE-451
Experimental: JTE-451 Dose 4; JTE-451 dose 4 for 28 days	Drug: JTE-451; Active drug tablets containing JTE-451
Experimental: Placebo; Placebo for 28 days	Drug: Placebo; Placebo tablets identical in appearance to the active drug tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	4 weeks
Percent change from baseline in the clinical target PLSS	Weeks 1, 2, 3 and 4
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
Number of subjects with clinical target lesion sPGA scores of 0 or 1	Week 1
Number of subjects with clinical target lesion sPGA scores of 0 or 1	Week 2
Number of subjects with clinical target lesion sPGA scores of 0 or 1	Week 3
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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): June 20, 2017
• Study Completion (Actual): June 20, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 29, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: psoriasis; JTE-451
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Psoriasis; Skin Diseases
• Other Study ID Numbers: AE451-X-16-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No