Single Dose PG102 in Patients With Active Psoriatic Arthritis

Phase 1TerminatedNCT00787137

PanGenetics UK Limited17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Arthritis, Psoriatic

Interventions

PG102DRUG

A single intravenous infusion

Placebo comparatorDRUG

Phosphate-buffered saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Professor Nemanja Damjanov

Belgrade, Serbia

Outcomes

Primary Outcomes

The Number of Reported Adverse Events

This was an exploratory study and all safety endpoints were considered.

Time frame: Three months

The Percentage of Participants With Adverse Events

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Three months

Data from ClinicalTrials.gov

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