Single Dose PG102 in Patients With Active Psoriatic Arthritis - Full Text View

Sponsored by:	PanGenetics UK Limited
Information provided by:	PanGenetics UK Limited
ClinicalTrials.gov Identifier:	NCT00787137

Purpose

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.

Condition	Intervention	Phase
Arthritis, Psoriatic	Drug: Anti-CD40 monoclonal antibody	Phase I

Drug Information available for: Immunoglobulins Globulin, Immune Dacetuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
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

Further study details as provided by PanGenetics UK Limited:

Primary Outcome Measures:

The number and percentage of reported adverse events, changes in vital signs and electrocardiograms and changes from baseline laboratory assessments tabulated by treatment group and overall for all patients who receive any study drug [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Terminal elimination half-life [ Time Frame: Three months ] [ Designated as safety issue: No ]
Dose-proportionality of the area under the serum concentration-time profile [ Time Frame: Extrapolated to infinite time ] [ Designated as safety issue: No ]
Binding of PG102 to B-cells [ Time Frame: Three months ] [ Designated as safety issue: No ]
CD4+/CD8+ lymphocyte populations [ Time Frame: Three months ] [ Designated as safety issue: No ]
C-Reactive Protein [ Time Frame: Three months ] [ Designated as safety issue: No ]
Histology of psoriatic skin lesion [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Clinical assessment of target psoriatic skin lesion [ Time Frame: Three months ] [ Designated as safety issue: No ]
Psoriatic Arthritis Response Criteria [ Time Frame: Three months ] [ Designated as safety issue: No ]
American College of Rheumatology Response Criteria [ Time Frame: Three months ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental Lowest dose PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion
Cohort 2: Experimental Second dose PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion
Cohort 3: Experimental Third dose of PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion
Cohort 4: Experimental Fourth dose of PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion
Cohort 5: Experimental Fifth dose of PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion
Cohort 6: Experimental Sixth dose of PG102 or placebo	Drug: Anti-CD40 monoclonal antibody A single intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Results outside the laboratory reference range 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787137

Contacts

Contact: John Powell, MD

+44 (0) 1763 249 513

John.Powell@PanGenetics.Com

Locations

Serbia
Professor Nemanja Damjanov	Recruiting
Belgrade, Serbia

Sponsors and Collaborators

PanGenetics UK Limited

Investigators

Principal Investigator:

Nemanja Damjanov, MD PhD

Institute of Rheumatology, Belgrade, Serbia

More Information

Responsible Party:	PanGenetics UK Limited ( John Powell )
Study ID Numbers:	PG102-01, Eudract 2007-001017-42
Study First Received:	November 6, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00787137
Health Authority:	Serbia: Agency for Medicines and Medical Devices; Hungary: National Institute of Pharmacy

Study placed in the following topic categories:

Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Bone Diseases
Antibodies, Monoclonal
Antibodies

Musculoskeletal Diseases
Psoriasis
Arthritis
Spondylarthritis
Skin Diseases, Papulosquamous
Immunoglobulins
Spondylarthropathies

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009