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Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384630
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
XBiotech, Inc.

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
Psoriasis Drug: RA-18C3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of the Safety, Pharmacokinetics, and Efficacy of a True Human Anti-inflammatory Therapeutic Antibody (RA-18C3) in Subjects With Moderate to Severe Plaque Psoriasis
Study Start Date : September 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Single group Drug: RA-18C3
200 mg subcutaneous injection

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 56 days ]
    Incidence and type of adverse clinical events

Secondary Outcome Measures :
  1. RA-18C3 Pharmacokinetics [ Time Frame: 56 days ]
    Serum levels of RA-18C3 will be measured to determine drug half-life, bioavailability, volume of distribution, and area under the curve.

  2. Psoriasis Area and Severity Index (PASI) [ Time Frame: 56 days ]
    Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90

  3. Erythrocyte Sedimentation Rate [ Time Frame: 56 days ]
  4. Physician's Global Assessment Score (PGA) [ Time Frame: 56 days ]
    Change in PGA from baseline to day 56

  5. Dermatology Life Quality Index Questionnaire (DLQI) [ Time Frame: 56 days ]
    Change in DLQI from baseline to day 56

  6. C-reactive protein [ Time Frame: 56 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects 18 years of age or older
  2. Diagnosis of plaque psoriasis for ≥ 6 months; INCLUDING subjects with chronic guttate lesions.
  3. Psoriasis area-and-severity index (PASI) score of ≥ 12
  4. Involvement of ≥ 5% of body-surface area
  5. 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.
  6. Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed

Exclusion Criteria:

  1. Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
  2. Treatment with conventional systemic psoriasis therapy within last 4 weeks
  3. Treatment with phototherapy within the last 4 weeks
  4. Topical psoriasis treatment with the last 2 weeks
  5. 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.
  6. 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
  7. Known HIV antibody, hepatitis B surface antigen and/or hepatitis C antibody.
  8. 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.
  9. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
  11. Infectious disease:

    CRP >30 mg/L, fever, or infection requiring treatment with antibiotics within 3 weeks prior to Screening

  12. Immunodeficiency
  13. History of treatment with Tysabri or Raptiva
  14. Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding
  15. Receipt of a live (attenuated) vaccine within 3 months prior to Screening
  16. Major surgery within 28 days prior to Day 0
  17. Participation in an investigational drug or device trial within 30 days prior to Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384630

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United States, Kentucky
West Kentucky Dermatology
Owensboro, Kentucky, United States, 42303
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Texas
Westlake Dermatology
Austin, Texas, United States, 78746
Sponsors and Collaborators
XBiotech, Inc.
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Principal Investigator: Johann Gudjonsson, M.D., PhD University of Michigan
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Responsible Party: XBiotech, Inc. Identifier: NCT01384630    
Other Study ID Numbers: 2011-PT019
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases