Trial Outcomes & Findings for Single Dose PG102 in Patients With Active Psoriatic Arthritis (NCT NCT00787137)

NCT ID: NCT00787137

Last Updated: 2010-10-26

Results Overview

This was an exploratory study and all safety endpoints were considered.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 17 participants
• Primary outcome timeframe: Three months
• Results posted on: 2010-10-26

Participant Flow

Eight study sites (rheumatology centres) in Serbia (3), Hungary (4) and the Russian Federation (1). The first patient's first visit was on December 2, 2008 and the last visit for the last patient was on April 21, 2010.

The first three patients in each cohort were dosed sequentially and could not be taking methotrexate. Subsequent patients in each cohort could be dosed simultaneously and could be taking methotrexate. There was a pause between dosing the last patient in the first cohort and the first patient in the second cohort.

Participant milestones

Measure	PG102 0.3 mg/kg Lowest dose PG102	PG102 1 mg/kg Second dose PG102	Placebo Control, phosphate-buffered saline
Overall Study STARTED	6	6	5
Overall Study COMPLETED	6	6	4
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	PG102 0.3 mg/kg Lowest dose PG102	PG102 1 mg/kg Second dose PG102	Placebo Control, phosphate-buffered saline
Overall Study Study Termination	0	0	1

Baseline Characteristics

Single Dose PG102 in Patients With Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	43.3 years FULL_RANGE 9.77 • n=5 Participants	43.8 years FULL_RANGE 10.85 • n=7 Participants	45.2 years FULL_RANGE 13.20 • n=5 Participants	44.0 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Serbia	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment Hungary	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: Three months

Population: All adverse events reported for all patients dosed were evaluated

This was an exploratory study and all safety endpoints were considered.

Outcome measures

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline
The Number of Reported Adverse Events	3 Number of adverse events	6 Number of adverse events	13 Number of adverse events

PRIMARY outcome

Timeframe: Three months

Population: All patients dosed were evaluated

Outcome measures

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline
The Percentage of Participants With Adverse Events	50 Percentage of Participants	67 Percentage of Participants	40 Percentage of Participants

PRIMARY outcome

Timeframe: Three months

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.

Outcome measures

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline
The Number of Episodes of Change in Vital Signs	0 Number of episodes of change	0 Number of episodes of change	1 Number of episodes of change

PRIMARY outcome

Timeframe: Three months

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.

Outcome measures

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline
The Number of Episodes of Change in Electrocardiogram	0 Number of episodes of change	0 Number of episodes of change	0 Number of episodes of change

PRIMARY outcome

Timeframe: Three months

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.

Outcome measures

Measure	PG102 0.3 mg/kg n=6 Participants Lowest dose PG102	PG102 1 mg/kg n=6 Participants Second dose PG102	Placebo n=5 Participants Control, phosphate-buffered saline
The Number of Episodes of Change From Screening in Laboratory Assessments	4 Number of episodes of change	7 Number of episodes of change	3 Number of episodes of change

Adverse Events

PG102 0.3 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

PG102 1 mg/kg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PG102 0.3 mg/kg n=6 participants at risk Lowest dose PG102	PG102 1 mg/kg n=6 participants at risk Second dose PG102	Placebo n=5 participants at risk Control, phosphate-buffered saline
Investigations Transaminases increased/hepatic enzymes increased	16.7% 1/6 • Number of events 1	66.7% 4/6 • Number of events 4	0.00% 0/5
Nervous system disorders Dizziness	0.00% 0/6	16.7% 1/6 • Number of events 1	20.0% 1/5 • Number of events 2
Nervous system disorders Headache	0.00% 0/6	0.00% 0/6	40.0% 2/5 • Number of events 6
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Number of events 1	0.00% 0/6	0.00% 0/5
Investigations Blood creatinine increased	16.7% 1/6 • Number of events 1	0.00% 0/6	0.00% 0/5
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6	16.7% 1/6 • Number of events 1	0.00% 0/5
General disorders Pyrexia	0.00% 0/6	0.00% 0/6	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Leucocytosis	0.00% 0/6	0.00% 0/6	20.0% 1/5 • Number of events 1
Investigations Neutrophil count increased	0.00% 0/6	0.00% 0/6	20.0% 1/5 • Number of events 1
General disorders Feeling hot	0.00% 0/6	0.00% 0/6	20.0% 1/5 • Number of events 1
Infections and infestations Influenza	0.00% 0/6	0.00% 0/6	20.0% 1/5 • Number of events 1

Additional Information

John Powell

PanGenetics UK Limited

Phone: +441763257869

Email: info@pangenetics.com

Results disclosure agreements

• Principal investigator is a sponsor employee An investigator shall not publish any data (poster, abstract, paper etc) without having consulted with the Sponsor in advance.
• Publication restrictions are in place

Restriction type: OTHER