Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Plaque Psoriasis	Drug: Apo805K1	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by ApoPharma:

Primary Outcome Measures:

Evaluate the safety and tolerability of 10 mg, 30 mg, 60 mg, and 100 mg of Apo805K1 in subjects with moderate to severe chronic plaque psoriasis. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability will be assessed by changes from baseline to post-baseline time points for: vital signs, 12-lead ECG, physical examinations and laboratory tests. Clinical monitoring of adverse events will occur throughout the study.

Secondary Outcome Measures:

Investigate the pharmacokinetics of 10 mg, 30 mg, 60 mg and 100 mg of Apo805K1 following daily administration for 14 days in subjects with moderate to severe chronic plaque psoriasis. [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
All pharmacokinetic derived parameters will be summarized. Data from the different doses will be compared to assess dose proportionality. Drug accumulation at Day 14 will be evaluated by comparing the appropriate pharmacokinetic parameters between Day 1 and Day 14.
To evaluate the efficacy of Apo805K1 using PASI, LS-PGA and PGA scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Efficacy will also be assessed by analyzing the proportion of subjects achieving PASI-75 (75% improvement in disease) and PASI-50 (50% improvement in disease) across the different treatment arms and at different time points throughout the study. PGA and LS-PGA scores will be assessed between increased doses and ordinal responses in scores will be assessed at different time points from baseline to end of study.
To evaluate the pharmacodynamics of Apo805K1 by assessing peripheral blood lymphocyte subsets. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Evaluation of pharmacodynamics will be assess using the change from baseline at various measurement times for each of the blood lymphocyte subsets. The effect of dose on the change from baseline will also be used to evaluate the pharmacodynamics.

Estimated Enrollment:	60
Study Start Date:	November 2011
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 10 mg Apo805K1, or placebo	Drug: Apo805K1 Sequential parallel dose escalation.
Experimental: 30 mg Apo805K1, or placebo	Drug: Apo805K1 Sequential parallel dose escalation.
Experimental: 60 mg Apo805K1, or placebo	Drug: Apo805K1 Sequential parallel dose escalation.
Experimental: 100 mg Apo805K1, or placebo	Drug: Apo805K1 Sequential parallel dose escalation.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483924

Contacts

Contact: Dian Shaw, RN

1-416-401-7283

dshaw@apotex.com

Locations

United States, California
Axis Clinical Trials	Terminated
Los Angeles, California, United States, 90036
Axis Clinical Trials	Recruiting
Los Angeles, California, United States, 90017
Contact: Patrick Clarke, MD 213-484-0180 drclarke@axistoday.com
United States, Texas
Menter Dermatology Research Institute	Recruiting
Dallas, Texas, United States, 75246
Contact: Alan Menter, MD 214-820-9115 amderm@gmail.com
Center for Clinical Studies	Recruiting
Houston, Texas, United States, 77030
Contact: Vandana Madkan, MD 713-528-8818 vmadkan@ccstexas.com
Center for Clinical Studies	Recruiting
Houston, Texas, United States, 77598
Contact: Stephen Tyring, MD 281-333-2288 styring@ccstexas.com
United States, Utah
The University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Gerald Krueger, MD 801-581-6465 gerald.krueger@hsc.utah.edu
Canada, Quebec
Innovaderm Research Inc.	Recruiting
Montreal, Quebec, Canada, H2K4L5
Contact: Simon Nigen, MD (514) 521-3111 ext 259 simonnigen@yahoo.com

Sponsors and Collaborators

ApoPharma

More Information

No publications provided

Responsible Party:	ApoPharma
ClinicalTrials.gov Identifier:	NCT01483924 History of Changes
Other Study ID Numbers:	AP03-0210
Study First Received:	November 30, 2011
Last Updated:	April 9, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by ApoPharma:

Mild to Moderate Chronic Plaque Psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013