Single Dose PG102 in Patients With Active Psoriatic Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Drug: PG102
* Drug: Placebo comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PG102 0.3 mg/kg<br>Lowest dose PG102 | Drug: PG102<br>* A single intravenous infusion<br>* Other names: Anti-CD40 monoclonal antibody;|
| Experimental: PG102 1 mg/kg<br>Second dose PG102 | Drug: PG102<br>* A single intravenous infusion<br>* Other names: Anti-CD40 monoclonal antibody;|
| Placebo Comparator: Placebo (phosphate-buffered saline)<br>Control | Drug: Placebo comparator<br>* Phosphate-buffered saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Reported Adverse Events | This was an exploratory study and all safety endpoints were considered. | Three months | 
| The Percentage of Participants With Adverse Events |  | Three months | 
| The Number of Episodes of Change in Vital Signs | 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. | Three months | 
| The Number of Episodes of Change in Electrocardiogram | 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. | Three months | 
| The Number of Episodes of Change From Screening in Laboratory Assessments | 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. | Three months |