Single Dose PG102 in Patients With Active Psoriatic Arthritis

PanGenetics

Status and phase: Terminated; Phase 1

Conditions: Arthritis, Psoriatic

Treatments: Drug: Placebo comparator; Drug: PG102

Study type: Interventional

Funder types: Industry

Identifiers

NCT00787137

PG102-01

2007-001017-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 3 patient groups, including a placebo group

PG102 0.3 mg/kg

Experimental group

Description:

Lowest dose PG102

Treatment:

Drug: PG102

PG102 1 mg/kg

Experimental group

Description:

Second dose PG102

Treatment:

Drug: PG102

Placebo (phosphate-buffered saline)

Placebo Comparator group

Description:

Control

Treatment:

Drug: Placebo comparator