Status:
COMPLETED
Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Lead Sponsor:
ApoPharma
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 pl...
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 effica...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01483924
Start Date
November 1 2011
End Date
October 1 2013
Last Update
February 20 2015
Active Locations (7)
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1
Axis Clinical Trials
Los Angeles, California, United States, 90017
2
Axis Clinical Trials
Los Angeles, California, United States, 90036
3
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
4
Center for Clinical Studies
Houston, Texas, United States, 77030