Single Dose PG102 in Patients With Active Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00787137
• Other study ID #: PG102-01
• Secondary ID: 2007-001017-42
• Status: Terminated
• Phase: Phase 1
• First received: November 6, 2008
• Last updated: October 15, 2010
• Start date: December 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: PanGenetics UK Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Agency for Medicines and Medical DevicesHungary: National Institute of PharmacyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• PG102
A single intravenous infusion
• Placebo comparator
Phosphate-buffered saline

Locations

Country	Name	City	State
Serbia	Professor Nemanja Damjanov	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
PanGenetics UK Limited

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Reported Adverse Events	This was an exploratory study and all safety endpoints were considered.	Three months	Yes
Primary	The Percentage of Participants With Adverse Events		Three months	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes