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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018509
• Other study ID #: AE451-X-16-003
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2017
• Last updated: June 29, 2017
• Start date: December 2016
• Est. completion date: June 20, 2017

Study information

• Verified date: June 2017
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Skin Diseases

Intervention

Drug:
• JTE-451
Active drug tablets containing JTE-451
• Placebo
Placebo tablets identical in appearance to the active drug tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		4 weeks
Primary	Percent change from baseline in the clinical target PLSS		Weeks 1, 2, 3 and 4
Primary	Percent change from baseline in the clinical target lesion erythema		Weeks 1, 2, 3 and 4
Primary	Percent change from baseline in the clinical target lesion induration		Weeks 1, 2, 3 and 4
Primary	Percent change from baseline in the clinical target lesion scaling		Weeks 1, 2, 3 and 4
Primary	Change from baseline in the clinical target lesion sPGA score		Weeks 1, 2, 3 and 4
Primary	Number of subjects with clinical target lesion sPGA scores of 0 or 1		Week 1
Primary	Number of subjects with clinical target lesion sPGA scores of 0 or 1		Week 2
Primary	Number of subjects with clinical target lesion sPGA scores of 0 or 1		Week 3
Primary	Number of subjects with clinical target lesion sPGA scores of 0 or 1		Week 4
Primary	Number of subjects with at least a 2-point improvement in sPGA score		Baseline to Week 4
Primary	Trough concentration during multiple dosing prior to next dose (Ctrough)		Weeks 1, 2, 3 and 4