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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:

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 Outcome Measures:

Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ]
Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ]
Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ]
AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14 [ Time Frame: 12 hours ]
T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.
Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores [ Time Frame: Baseline to 12 Weeks ]
PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.
Efficacy of APO805K1 as Assessed by Achievement of PASI-75 [ Time Frame: 12 weeks ]
The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12
Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores [ Time Frame: Baseline to 12 weeks ]
The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from "none" to "marked"; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group.
Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score [ Time Frame: Baseline to 12 weeks ]
In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.


Enrollment:	60
Study Start Date:	November 2011
Study Completion Date:	October 2013
Primary Completion Date:	August 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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90017
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Center for Clinical Studies
Houston, Texas, United States, 77030
Center for Clinical Studies
Houston, Texas, United States, 77598
United States, Utah
The University of Utah
Salt Lake City, Utah, United States, 84132
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K4L5

Sponsors and Collaborators

ApoPharma

More Information


Responsible Party:	ApoPharma
ClinicalTrials.gov Identifier:	NCT01483924 History of Changes
Other Study ID Numbers:	AP03-0210
Study First Received:	November 30, 2011
Results First Received:	January 20, 2015
Last Updated:	February 9, 2015

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 July 17, 2017