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

NCT03018509 | Completed Phase 1

• 1 other identifier: AE451-X-16-003
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

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

Keywords

JTE-451; psoriasis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (5)

JTE-451 Dose 1

EXPERIMENTAL

JTE-451 dose 1 for 28 days

Drug: JTE-451

JTE-451 Dose 2

EXPERIMENTAL

JTE-451 dose 2 for 28 days

Drug: JTE-451

JTE-451 Dose 3

EXPERIMENTAL

JTE-451 dose 3 for 28 days

Drug: JTE-451

JTE-451 Dose 4

EXPERIMENTAL

JTE-451 dose 4 for 28 days

Drug: JTE-451

Placebo

EXPERIMENTAL

Placebo for 28 days

Drug: Placebo

Interventions

JTE-451 DRUG

Active drug tablets containing JTE-451

JTE-451 Dose 1; JTE-451 Dose 2; JTE-451 Dose 3; JTE-451 Dose 4

Placebo DRUG

Placebo tablets identical in appearance to the active drug tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Akros Pharma Inc.: lead

Study Sites (5)

Unknown Facility

Surrey, British Columbia, Canada

Location

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Peterborough, Ontario, Canada

Location

Unknown Facility

Richmond Hill, Ontario, Canada

Location

Unknown Facility

Waterloo, Ontario, Canada

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 12, 2017
• Study Start: December 1, 2016
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)