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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XBiotech, Inc.
ClinicalTrials.gov Identifier:
NCT01384630
First received: June 8, 2011
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Psoriasis
 Drug: RA-18C3
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by XBiotech, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Incidence and type of adverse clinical events


Secondary Outcome Measures:
  • RA-18C3 Pharmacokinetics [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Percentage of subjects that acheive PASI 50, PASI 75, and PASI 90

  • Erythrocyte Sedimentation Rate [ Time Frame: 56 days ] [ Designated as safety issue: No ]
  • Physician's Global Assessment Score (PGA) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Change in PGA from baseline to day 56

  • Dermatology Life Quality Index Questionnaire (DLQI) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
    Change in DLQI from baseline to day 56

  • C-reactive protein [ Time Frame: 56 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single group Drug: RA-18C3
200 mg subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384630

Locations
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.
Investigators
Principal Investigator: Johann Gudjonsson, M.D., PhD University of Michigan
  More Information

No publications provided

Responsible Party: XBiotech, Inc.
ClinicalTrials.gov Identifier: NCT01384630     History of Changes
Other Study ID Numbers: 2011-PT019
Study First Received: June 8, 2011
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013