Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
Study Details
Study Description
Brief Summary
This is a 73-day phase II, open label trial of the true human monoclonal antibody RA-18C3 in subjects with moderate to severe plaque psoriasis. Ten (10) subjects will receive 200 mg of RA-18C3 via subcutaneous injection. Subjects will receive injections at Days 0, 21, and 42 for a total of 3 injections. Study drug will be administered under close observation in a facility equipped to handle medical emergencies. Subjects will not be discharged from the facility until at least 1 hour following the end of the injection or 1 hour after their vital signs have stabilized. Safety will be assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single group
|
Drug: RA-18C3
200 mg subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability [56 days]
Incidence and type of adverse clinical events
Secondary Outcome Measures
- RA-18C3 Pharmacokinetics [56 days]
Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.
- Psoriasis Area and Severity Index (PASI) [56 days]
Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90
- Erythrocyte Sedimentation Rate [56 days]
- Physician's Global Assessment Score (PGA) [56 days]
Change in PGA from baseline to day 56
- Dermatology Life Quality Index Questionnaire (DLQI) [56 days]
Change in DLQI from baseline to day 56
- C-reactive protein [56 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects 18 years of age or older
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Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions.
-
Psoriasis area-and-severity index (PASI) score of ≥ 12
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Involvement of ≥ 5% of body-surface area
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For female subjects of childbearing age, a negative urine pregnancy test at screening and at specified time points throughout the trial. For subjects with reproductive potential, a willingness to utilize adequate, double barrier contraception during the study and including 3 months after study completion. Sexually active men must use an accepted method of contraception during the study and including 3 months after study completion.
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Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed
Exclusion Criteria:
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Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
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Treatment with conventional systemic psoriasis therapy within last 4 weeks
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Treatment with phototherapy within the last 4 weeks
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Topical psoriasis treatment with the last 2 weeks
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History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing congestive heart failure, and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
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Hemoglobin <10.0 g/dL, WBC <3.0 x 103/mm3, platelet count <125 x 103/mm3, creatinine > 1.5mg/dL, AST/ALT >2 x ULN, alkaline phosphatase >2 x ULN
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Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
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History of malignancy within 5 years prior to study entry other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
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History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
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History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
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Infectious disease:
CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
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Immunodeficiency
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History of treatment with Tysabri or Raptiva
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Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
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Receipt of a live (attenuated) vaccine within 3 months prior to Screening
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Major surgery within 28 days prior to Day 0
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Participation in an investigational drug or device trial within 30 days prior to Screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West Kentucky Dermatology | Owensboro | Kentucky | United States | 42303 |
| 2 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 3 | Westlake Dermatology | Austin | Texas | United States | 78746 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Principal Investigator: Johann Gudjonsson, M.D., PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011-PT019