Single Dose PG102 in Patients With Active Psoriatic Arthritis

NCT00787137 | Terminated Phase 1 Results DMC

• 2 other identifiers: PG102-012007-001017-42
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

PG102 0.3 mg/kg

EXPERIMENTAL

Lowest dose PG102

Drug: PG102

PG102 1 mg/kg

EXPERIMENTAL

Second dose PG102

Drug: PG102

Placebo (phosphate-buffered saline)

PLACEBO COMPARATOR

Control

Drug: Placebo comparator

Interventions

PG102 DRUG

A single intravenous infusion

Also known as: Anti-CD40 monoclonal antibody

PG102 0.3 mg/kg; PG102 1 mg/kg

Placebo comparator DRUG

Phosphate-buffered saline

Placebo (phosphate-buffered saline)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
• Plaque psoriasis for at least 6 months prior to study enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• PanGenetics UK Limited: lead

Study Sites (1)

Professor Nemanja Damjanov

Belgrade, Serbia

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Termination prior to accrual of planned numbers of participants

Results Point of Contact

• Title: John Powell
• Organization: PanGenetics UK Limited

info@pangenetics.com

+441763257869

Study Officials

• Nemanja Damjanov, MD PhD

  Institute of Rheumatology, Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 26, 2010
• Results First Posted: October 15, 2010

Record last verified: 2010-10

Locations

SE (1)