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

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 Overview

• Status: Terminated
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: PG102; Drug: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia
    • Professor Nemanja Damjanov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PanGenetics UK Limited
• Investigators: Principal Investigator: Nemanja Damjanov, MD PhD, Institute of Rheumatology, Belgrade, Serbia

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: PG102-01; 2007-001017-42 (EudraCT Number)