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

ApoPharma5 sites in 2 countries60 target enrollmentNovember 2011

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ApoPharma

Responsible Party

Sponsor

Eligibility Criteria

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) ≥
•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.

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

Arms & Interventions

30 mg Apo805K1, or placebo

Intervention: Apo805K1

10 mg Apo805K1, or placebo

Intervention: Apo805K1

60 mg Apo805K1, or placebo

Intervention: Apo805K1

100 mg Apo805K1, or placebo

Intervention: Apo805K1

Outcomes

Primary Outcomes

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

Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14(12 hours)
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores(Baseline to 12 Weeks)
Efficacy of APO805K1 as Assessed by Achievement of PASI-75(12 weeks)
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score(Baseline to 12 weeks)
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores(Baseline to 12 weeks)