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Completed

NCT Number: NCT03018509

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

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

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Key information

Conditions

Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

JTE-451

Drug

Active drug tablets containing JTE-451

Placebo

Drug

Placebo tablets identical in appearance to the active drug tablets

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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