Single Dose PG102 in Patients With Active Psoriatic Arthritis

Phase 1

Terminated

Conditions: Arthritis, Psoriatic

Interventions: Drug: PG102
Drug: Placebo comparator

Registration Number: NCT00787137

Lead Sponsor: PanGenetics UK Limited

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 Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 17

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG102 0.3 mg/kg	PG102	Lowest dose PG102
PG102 1 mg/kg	PG102	Second dose PG102
Placebo (phosphate-buffered saline)	Placebo comparator	Control

Primary Outcome Measures

Name	Time	Method
The Number of Reported Adverse Events	Three months	This was an exploratory study and all safety endpoints were considered.
The Percentage of Participants With Adverse Events	Three months
The Number of Episodes of Change in Vital Signs	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	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	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 transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.