Psoriasis Clinical Trial

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

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.

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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

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT01483924

Recruitment Status:

Completed

Sponsor:

ApoPharma

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There are 7 Locations for this study

See Locations Near You

Axis Clinical Trials
Los Angeles California, 90017, United States
Axis Clinical Trials
Los Angeles California, 90036, United States
Menter Dermatology Research Institute
Dallas Texas, 75246, United States
Center for Clinical Studies
Houston Texas, 77030, United States
Center for Clinical Studies
Houston Texas, 77598, United States
The University of Utah
Salt Lake City Utah, 84132, United States
Innovaderm Research Inc.
Montreal Quebec, H2K4L, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT01483924

Recruitment Status:

Completed

Sponsor:


ApoPharma

How clear is this clinincal trial information?

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