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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
British Columbia
-
Surrey, British Columbia, Canada
-
-
Ontario
-
Markham, Ontario, Canada
-
Peterborough, Ontario, Canada
-
Richmond Hill, Ontario, Canada
-
Waterloo, Ontario, Canada
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: JTE-451 Dose 1
JTE-451 dose 1 for 28 days
|
Active drug tablets containing JTE-451
|
|
Experimental: JTE-451 Dose 2
JTE-451 dose 2 for 28 days
|
Active drug tablets containing JTE-451
|
|
Experimental: JTE-451 Dose 3
JTE-451 dose 3 for 28 days
|
Active drug tablets containing JTE-451
|
|
Experimental: JTE-451 Dose 4
JTE-451 dose 4 for 28 days
|
Active drug tablets containing JTE-451
|
|
Experimental: Placebo
Placebo for 28 days
|
Placebo tablets identical in appearance to the active drug tablets
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of adverse events
Time Frame: 4 weeks
|
4 weeks
|
|
Percent change from baseline in the clinical target PLSS
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
|
Percent change from baseline in the clinical target lesion erythema
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
|
Percent change from baseline in the clinical target lesion induration
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
|
Percent change from baseline in the clinical target lesion scaling
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
|
Change from baseline in the clinical target lesion sPGA score
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
|
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time Frame: Week 1
|
Week 1
|
|
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time Frame: Week 2
|
Week 2
|
|
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time Frame: Week 3
|
Week 3
|
|
Number of subjects with clinical target lesion sPGA scores of 0 or 1
Time Frame: Week 4
|
Week 4
|
|
Number of subjects with at least a 2-point improvement in sPGA score
Time Frame: Baseline to Week 4
|
Baseline to Week 4
|
|
Trough concentration during multiple dosing prior to next dose (Ctrough)
Time Frame: Weeks 1, 2, 3 and 4
|
Weeks 1, 2, 3 and 4
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- AE451-X-16-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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