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

ApoPharma

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Apo805K1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01483924

AP03-0210

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups

10 mg Apo805K1, or placebo

Experimental group

Treatment:

Drug: Apo805K1

30 mg Apo805K1, or placebo

Experimental group

Treatment:

Drug: Apo805K1

60 mg Apo805K1, or placebo

Experimental group

Treatment:

Drug: Apo805K1

100 mg Apo805K1, or placebo

Experimental group

Treatment:

Drug: Apo805K1