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

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ClinicalTrials.gov Identifier: NCT03018509
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Psoriasis Skin Diseases Drug: JTE-451 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2016
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 4 weeks ]
  2. Percent change from baseline in the clinical target PLSS [ Time Frame: Weeks 1, 2, 3 and 4 ]
  3. Percent change from baseline in the clinical target lesion erythema [ Time Frame: Weeks 1, 2, 3 and 4 ]
  4. Percent change from baseline in the clinical target lesion induration [ Time Frame: Weeks 1, 2, 3 and 4 ]
  5. Percent change from baseline in the clinical target lesion scaling [ Time Frame: Weeks 1, 2, 3 and 4 ]
  6. Change from baseline in the clinical target lesion sPGA score [ Time Frame: Weeks 1, 2, 3 and 4 ]
  7. Number of subjects with clinical target lesion sPGA scores of 0 or 1 [ Time Frame: Week 1 ]
  8. Number of subjects with clinical target lesion sPGA scores of 0 or 1 [ Time Frame: Week 2 ]
  9. Number of subjects with clinical target lesion sPGA scores of 0 or 1 [ Time Frame: Week 3 ]
  10. Number of subjects with clinical target lesion sPGA scores of 0 or 1 [ Time Frame: Week 4 ]
  11. Number of subjects with at least a 2-point improvement in sPGA score [ Time Frame: Baseline to Week 4 ]
  12. Trough concentration during multiple dosing prior to next dose (Ctrough) [ Time Frame: Weeks 1, 2, 3 and 4 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018509


Locations
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Canada, British Columbia
Surrey, British Columbia, Canada
Canada, Ontario
Markham, Ontario, Canada
Peterborough, Ontario, Canada
Richmond Hill, Ontario, Canada
Waterloo, Ontario, Canada
Sponsors and Collaborators
Akros Pharma Inc.

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Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT03018509     History of Changes
Other Study ID Numbers: AE451-X-16-003
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Akros Pharma Inc.:
JTE-451
psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous