search
Back to results

Single Dose PG102 in Patients With Active Psoriatic Arthritis

Primary Purpose

Arthritis, Psoriatic

Status
Terminated
Phase
Phase 1
Locations
Serbia
Study Type
Interventional
Intervention
PG102
Placebo comparator
Sponsored by
PanGenetics UK Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Professor Nemanja Damjanov

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PG102 0.3 mg/kg

PG102 1 mg/kg

Placebo (phosphate-buffered saline)

Arm Description

Lowest dose PG102

Second dose PG102

Control

Outcomes

Primary Outcome Measures

The Number of Reported Adverse Events
This was an exploratory study and all safety endpoints were considered.
The Percentage of Participants With Adverse Events
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2008
Last Updated
October 15, 2010
Sponsor
PanGenetics UK Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT00787137
Brief Title
Single Dose PG102 in Patients With Active Psoriatic Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PanGenetics UK Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PG102 0.3 mg/kg
Arm Type
Experimental
Arm Description
Lowest dose PG102
Arm Title
PG102 1 mg/kg
Arm Type
Experimental
Arm Description
Second dose PG102
Arm Title
Placebo (phosphate-buffered saline)
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
PG102
Other Intervention Name(s)
Anti-CD40 monoclonal antibody
Intervention Description
A single intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Phosphate-buffered saline
Primary Outcome Measure Information:
Title
The Number of Reported Adverse Events
Description
This was an exploratory study and all safety endpoints were considered.
Time Frame
Three months
Title
The Percentage of Participants With Adverse Events
Time Frame
Three months
Title
The Number of Episodes of Change in Vital Signs
Description
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.
Time Frame
Three months
Title
The Number of Episodes of Change in Electrocardiogram
Description
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.
Time Frame
Three months
Title
The Number of Episodes of Change From Screening in Laboratory Assessments
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nemanja Damjanov, MD PhD
Organizational Affiliation
Institute of Rheumatology, Belgrade, Serbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Nemanja Damjanov
City
Belgrade
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

Single Dose PG102 in Patients With Active Psoriatic Arthritis

We'll reach out to this number within 24 hrs