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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ApoPharma
ClinicalTrials.gov Identifier:
NCT01483924
First received: November 30, 2011
Last updated: February 9, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: Apo805K1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ApoPharma:

Primary Outcome Measures:
  • Number of Patients With Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

    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.

    .


  • Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.

  • AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.

  • T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    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.

  • Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]
    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.

  • Efficacy of APO805K1 as Assessed by Achievement of PASI-75 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg Apo805K1, or placebo Drug: Apo805K1
Sequential parallel dose escalation.
Experimental: 30 mg Apo805K1, or placebo Drug: Apo805K1
Sequential parallel dose escalation.
Experimental: 60 mg Apo805K1, or placebo Drug: Apo805K1
Sequential parallel dose escalation.
Experimental: 100 mg Apo805K1, or placebo Drug: Apo805K1
Sequential parallel dose escalation.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483924

Locations
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90017
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77030
Center for Clinical Studies
Houston, Texas, United States, 77598
United States, Utah
The University of Utah
Salt Lake City, Utah, United States, 84132
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K4L5
Sponsors and Collaborators
ApoPharma
  More Information

No publications provided

Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT01483924     History of Changes
Other Study ID Numbers: AP03-0210
Study First Received: November 30, 2011
Results First Received: January 20, 2015
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by ApoPharma:
Mild to Moderate Chronic Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 29, 2015