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This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX003 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by number of subjects with adverse events | 6 months | |
| Determination of pharmacokinetics parameters | time of the maximum measured concentration (Tmax) | 20 weeks |
| Determination of pharmacokinetics parameters | area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast) | 20 weeks |
| Determination of pharmacokinetics parameters | maximum concentration (Cmax) | 20 weeks |
| Determination of pharmacokinetics parameters | area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | 20 weeks |
| Determination of pharmacokinetics parameters | elimination rate constant | 20 weeks |
| Determination of pharmacokinetics parameters | terminal elimination half life (t½) | 20 weeks |
| Determination of pharmacokinetics parameters | clearance (CL) | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity as determined by measurement of anti-PRX003 antibodies | antibody titers will be listed and summarized | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar, or an unstable form of psoriasis
Receipt of any of the following within the specified time frame prior to Baseline (Day 1/Visit 2):
Participation in recreational sunbathing or use of a sun-bed (e.g., tanning salon) within 7 days prior to Baseline (Day 1)
Any major medical illness or unstable medical condition that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including, but not limited to:
Hypotension (systolic blood pressure [BP] ≤85 millimeters of mercury [mmHg]) at Baseline (Day 1/Visit 2) predose or a known history or documentation of hypotension on more than one occasion within 3 months prior to Baseline (Day 1/Visit 2)
Uncontrolled hypertension as indicated by a resting systolic BP ≥150 mmHg or diastolic BP ≥95 mmHg at Screening (Visit 1) or Baseline (Day 1/Visit 2) predose or a known history or documentation of uncontrolled hypertension on more than one occasion within 3 months prior to Baseline (Day 1/Visit 2)
Clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, upper respiratory infection) within 30 days of Baseline (Day 1/ Visit 2), or a history or presence of recurrent or chronic infection (e.g., viral infections [including hepatitis B or C, human immunodeficiency virus (HIV)], bacterial infections, systemic fungal infections, or syphilis)
History of any inflammatory bowel disease
Any current psychiatric diagnosis according to Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR) that may interfere with the subject's ability to perform the study and all assessments (e.g., alcohol or drug-related abuse or alcohol dependence, or alcohol or drug-related dementia, major depression, developmental disability, schizophrenia, bipolar disorder). Note: Subjects with adequately controlled depression for at least 6 months are not excluded; however, suicidal ideation or attempt at any time within the past year is exclusionary.
A positive tuberculosis skin test (TST) or a positive interferon-gamma release assay (IGRA) during Screening (Visit 1).
Note: In the event a subject has had a TST or IGRA within 3 months before Baseline (Day 1/Visit 2), this does not need to be repeated during screening and the previous result can be carried forward and used in this study.
Prior standard treatment for latent tuberculosis and prior exposure to tuberculosis with subsequent standard prophylactic treatment is allowed if recent (within Ë‚ 30 days) negative chest X-ray.
Any of the following laboratory abnormalities at Screening (Visit 1):
Use of an investigational product or device or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) prior to Screening (Visit 1); for investigational products or drug research studies relating to psoriasis or arthritis, the duration will be extended to 12 weeks (or 5 half-lives of the drug, whichever is longer) prior to Screening (Visit 1)
Allergy to any of the components of PRX003 such as histidine, sucrose and polysorbate 20
Receipt of any vaccine (with the exception of seasonal influenza) within 30 days prior to Screening (Visit 1)
Donation of >500 mL of blood within 3 months prior to Screening (Visit 1)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCR Medical Corporation | San Diego | California | 92123 | United States | ||
| Universal Medical and Research Center, LLC |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| Determination of pharmacokinetics parameters |
apparent volume of distribution (Vd) |
| 20 weeks |
| Determination of pharmacokinetics parameters | average concentration over a dosing interval (Cav) | 20 weeks |
| Determination of pharmacokinetics parameters | area under the plasma concentration-time curve for a dosing interval (AUCtau) | 20 weeks |
| Determination of pharmacokinetics parameters | minimum observed concentration (Cmin) | 20 weeks |
| Coral Gables |
| Florida |
| United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| UPMC Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| Dermatology Treatment and Research Center, PA | Dallas | Texas | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | United States |
| Virginia Clinical Research Inc. | Norfolk | Virginia | 23502 | United States |