Title
Single Dose PG102 in Patients With Active Psoriatic Arthritis
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 Active Psoriatic Arthritis
Phase
Phase 1Lead Sponsor
PanGenetics UK LimitedStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Arthritis, PsoriaticIntervention/Treatment
pg-102 ...Study Participants
17The 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.
A single intravenous infusion
Phosphate-buffered saline
Inclusion Criteria: Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria Plaque psoriasis for at least 6 months prior to study enrollment Exclusion Criteria: Clinically significant psoriasis flare Unstable doses of pain relief medication Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent Treatment with any biologic therapy Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI Currently smoking ≥ 10 cigarettes per day or equivalent Active tuberculosis or other infection Current or previous malignancies Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
| Event Type | Organ System | Event Term | PG102 0.3 mg/kg | PG102 1 mg/kg | Placebo |
|---|
This was an exploratory study and all safety endpoints were considered.
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.
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.
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 transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.
