Trial Outcomes & Findings for Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment (NCT NCT02587819)
NCT ID: NCT02587819
Last Updated: 2016-04-14
Results Overview
Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
COMPLETED
PHASE1
21 participants
8 weeks
2016-04-14
Participant Flow
Participant milestones
| Measure |
Treatment With BSCT
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
Exposed
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment With BSCT
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Investigation of the Safety and Tolerability of BSCT (Anti-nf-P2X7) 10% Ointment
Baseline characteristics by cohort
| Measure |
Treatment With BSCT
n=21 Participants
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
|
|---|---|
|
Age, Continuous
|
65.0 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.
Outcome measures
| Measure |
Treatment With BSCT
n=21 Participants
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Subjects with any Serious Adverse Events
|
1 participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Subjects with Treatment-emergent Adverse Event(s)
|
12 participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.
To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.
Outcome measures
| Measure |
Treatment With BSCT
n=21 Participants
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
|
|---|---|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
Pre-dose - Baseline visit
|
NA ng/ml
All patients had levels of sheep IgG below limit of quantitation.
|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
Pre dose - Visit 5
|
NA ng/ml
Interval to 24.68
The majority of patients had levels of sheep IgG below limit of quantitation.
|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
Pre dose - Visit 6
|
NA ng/ml
Interval to 22.85
The majority of patients had levels of sheep IgG below limit of quantitation.
|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
2 hours post dose - Visit 6
|
NA ng/ml
All patients had levels of sheep IgG below limit of quantitation.
|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
4 hours post dose - Visit 6
|
NA ng/ml
All patients had levels of sheep IgG below limit of quantitation.
|
|
Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.
1 hour post dose - Visit 6
|
NA ng/ml
Interval to 7.08
The majority of patients had levels of sheep IgG below limit of quantitation.
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.
The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).
Outcome measures
| Measure |
Treatment With BSCT
n=21 Participants
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
|
|---|---|
|
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Subjects with anti sheep IgG at screening
|
42.9 percentage of subjects
|
|
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Subjects with anti sheep IgG at Baseline
|
38.1 percentage of subjects
|
|
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Subjects with anti sheep IgG at visit 6
|
50 percentage of subjects
|
|
Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.
Subjects with anti sheep IgG at visit 8
|
52.6 percentage of subjects
|
POST_HOC outcome
Timeframe: 28 daysPopulation: Final area of lesion was not recorded for one subject.
BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.
Outcome measures
| Measure |
Treatment With BSCT
n=20 Participants
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
|
|---|---|
|
Change in Lesion Size.
|
-12.86 percentage change in tumour area
Standard Error 5.88
|
Adverse Events
Treatment With BSCT
Serious adverse events
| Measure |
Treatment With BSCT
n=21 participants at risk
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
4.8%
1/21 • Number of events 1 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
Other adverse events
| Measure |
Treatment With BSCT
n=21 participants at risk
BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
|
|---|---|
|
General disorders
Application site dryness
|
33.3%
7/21 • Number of events 7 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
General disorders
Application site erythema
|
47.6%
10/21 • Number of events 10 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
General disorders
Application site exfoliation
|
23.8%
5/21 • Number of events 5 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
General disorders
Application site pain
|
14.3%
3/21 • Number of events 3 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
General disorders
Application site pruritus
|
23.8%
5/21 • Number of events 5 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • 8 weeks (28 day treatment period and 28 day follow up period).
All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place