Clinical trial NCT01483924: Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: Mild to Moderate Chronic Plaque Psoriasis
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 plaque psoriasis.

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 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

Primary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: 12 Weeks
Secondary outcomes:
measure: Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
timeFrame: 12 hours
measure: Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14
timeFrame: 12 hours
measure: AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14
timeFrame: 12 hours
measure: T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14
timeFrame: 12 hours
measure: Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores
timeFrame: Baseline to 12 Weeks
measure: Efficacy of APO805K1 as Assessed by Achievement of PASI-75
timeFrame: 12 weeks
measure: Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores
timeFrame: Baseline to 12 weeks
measure: Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
References: