Clinical Trial: Single Dose PG102 in Patients With Active Psoriatic Arthritis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With

Brief Summary: The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.

Detailed Summary:
Sponsor: PanGenetics UK Limited

Current Primary Outcome:

  • The Number of Reported Adverse Events [ Time Frame: Three months ]
    This was an exploratory study and all safety endpoints were considered.
  • The Percentage of Participants With Adverse Events [ Time Frame: Three months ]
  • The Number of Episodes of Change in Vital Signs [ Time Frame: Three months ]
    Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.
  • The Number of Episodes of Change in Electrocardiogram [ Time Frame: Three months ]
    Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.
  • The Number of Episodes of Change From Screening in Laboratory Assessments [ Time Frame: Three months ]
    Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl t

    Original Primary Outcome: The number and percentage of reported adverse events, changes in vital signs and electrocardiograms and changes from baseline laboratory assessments tabulated by treatment group and overall for all patients who receive any study drug. [ Time Frame: Three months ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    • Terminal elimination half-life [ Time Frame: Three months ]
    • Dose-proportionality of the area under the serum concentration-time profile [ Time Frame: Extrapolated to infinite time ]
    • Binding of PG102 to B-cells [ Time Frame: Three months ]
    • CD4+/CD8+ lymphocyte populations [ Time Frame: Three months ]
    • C-Reactive Protein and other markers of systemic inflammation [ Time Frame: Three months ]
    • Histology of psoriatic skin lesion [ Time Frame: Two weeks ]
    • Clinical assessment of target psoriatic skin lesion [ Time Frame: Three months ]
    • Psoriatic Arthritis Response Criteria [ Time Frame: Three months ]
    • American College of Rheumatology Response Criteria [ Time Frame: Three months ]


    Information By: PanGenetics UK Limited

    Dates:
    Date Received: November 6, 2008
    Date Started: December 2008
    Date Completion:
    Last Updated: October 15, 2010
    Last Verified: October 2010