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Completed

NCT Number: NCT01483924

Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innovaderm Research Inc., Montreal, Quebec, Canada

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About this study

A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1

B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days

C) To evaluate the efficacy and pharmacodynamics of Apo805K1

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥10.
  • Male and female subjects 18 to 65 years of age, inclusive.
  • At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
  • Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.

Main Exclusion Criteria:

  • Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
  • Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
  • Phototherapy within 30 days prior to Baseline assessment and during the study.
  • Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
  • History of liver disease or abnormal liver enzymes
  • Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
  • Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
  • Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
  • History of chronic infection or malignancy

Treatment and study plan

Apo805K1

Drug

Sequential parallel dose escalation.

Primary outcomes

  1. Number of Patients With Adverse Events

    Time frame: 12 Weeks

    The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.

Secondary outcomes

  1. Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14

    Time frame: 12 hours

    Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

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  2. Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14

    Time frame: 12 hours

    Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

  3. AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14

    Time frame: 12 hours

    AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

  4. T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14

    Time frame: 12 hours

    T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.

  5. Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores

    Time frame: Baseline to 12 Weeks

    PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.

  6. Efficacy of APO805K1 as Assessed by Achievement of PASI-75

    Time frame: 12 weeks

    The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12

  7. Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores

    Time frame: Baseline to 12 weeks

    The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from "none" to "marked"; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.

  8. Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score

    Time frame: Baseline to 12 weeks

    In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.

Sponsors and collaborators

Lead sponsor

ApoPharma

Industry

Registry information

Official study title

A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2011
Registry last updated
Feb 20, 2015

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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