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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RA-18C3 | Drug | 200 mg subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and type of adverse clinical events | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| RA-18C3 Pharmacokinetics | Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve. | 56 days |
| Psoriasis Area and Severity Index (PASI) |
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Inclusion Criteria:
Exclusion Criteria:
Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
Treatment with conventional systemic psoriasis therapy within last 4 weeks
Treatment with phototherapy within the last 4 weeks
Topical psoriasis treatment with the last 2 weeks
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.
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
Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
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.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
Infectious disease:
CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening
Immunodeficiency
History of treatment with Tysabri or Raptiva
Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
Receipt of a live (attenuated) vaccine within 3 months prior to Screening
Major surgery within 28 days prior to Day 0
Participation in an investigational drug or device trial within 30 days prior to Screening
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| Name | Affiliation | Role |
|---|---|---|
| Johann Gudjonsson, M.D., PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kentucky Dermatology | Owensboro | Kentucky | 42303 | United States | ||
| University of Michigan |
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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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| ID | Term |
|---|---|
| C000604877 | bermekimab |
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Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90
| 56 days |
| Erythrocyte Sedimentation Rate | 56 days |
| Physician's Global Assessment Score (PGA) | Change in PGA from baseline to day 56 | 56 days |
| Dermatology Life Quality Index Questionnaire (DLQI) | Change in DLQI from baseline to day 56 | 56 days |
| C-reactive protein | 56 days |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Westlake Dermatology | Austin | Texas | 78746 | United States |