Trial Outcomes & Findings for Efficacy and Safety of XT-150 in Osteoarthritis of the Knee (NCT NCT04124042)
NCT ID: NCT04124042
Last Updated: 2025-03-27
Results Overview
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
289 participants
Primary outcome timeframe
Day 180
Results posted on
2025-03-27
Participant Flow
289 participants signed a consent form, but 3 withdrew during the screening period. 286 participants were dosed and that is the number reflected in this section. The data listed here is based on the Safety Population and actual treatment received, not the ITT population. One participant received 0.15mg due to a site error, although they were originally randomized to 0.45mg in Stage A.
Participant milestones
| Measure |
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
Low dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
Low dose active in Stage A, high dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
High dose active in Stage A, low dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
47
|
47
|
47
|
48
|
48
|
|
Overall Study
COMPLETED
|
39
|
42
|
38
|
39
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
9
|
8
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of XT-150 in Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=49 Participants
Low dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 Participants
Low dose active in Stage A, high dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=47 Participants
High dose active in Stage A, low dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=48 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=48 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 6.68 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 7.09 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 7.82 • n=4 Participants
|
62.9 years
STANDARD_DEVIATION 7.35 • n=21 Participants
|
65.3 years
STANDARD_DEVIATION 9.52 • n=10 Participants
|
63.3 years
STANDARD_DEVIATION 7.79 • n=115 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
155 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
131 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
46 Participants
n=10 Participants
|
272 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
223 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Body Mass Index
|
32.482 kg/m2
STANDARD_DEVIATION 7.398 • n=5 Participants
|
31.823 kg/m2
STANDARD_DEVIATION 7.087 • n=7 Participants
|
31.101 kg/m2
STANDARD_DEVIATION 7.192 • n=5 Participants
|
33.401 kg/m2
STANDARD_DEVIATION 8.190 • n=4 Participants
|
32.405 kg/m2
STANDARD_DEVIATION 5.234 • n=21 Participants
|
31.659 kg/m2
STANDARD_DEVIATION 7.236 • n=10 Participants
|
32.150 kg/m2
STANDARD_DEVIATION 7.047 • n=115 Participants
|
PRIMARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=95 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=95 Participants
High dose active in Stage A
|
Stage A: Placebo
n=96 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score
Responder
|
26 Participants
|
28 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score
Non-responder
|
53 Participants
|
56 Participants
|
51 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants Achieving 30% Improvement From Baseline in Western Ontario and McMasters Arthritis Index (WOMAC) Pain Score
Not Analyzed
|
16 Participants
|
11 Participants
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=95 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=95 Participants
High dose active in Stage A
|
Stage A: Placebo
n=96 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A: Change From Baseline in WOMAC Pain Score at Day 180
|
-1.77 score on a scale
Standard Error 0.386
|
-1.95 score on a scale
Standard Error 0.380
|
-2.21 score on a scale
Standard Error 0.374
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Prior to second dose (Up to Day 180-Day 330)Population: The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received.
Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events (TEAEs) occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred prior to the second dose.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=96 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=94 Participants
High dose active in Stage A
|
Stage A: Placebo
n=96 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs · Yes
|
30 Participants
|
53 Participants
|
38 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAEs · No
|
66 Participants
|
41 Participants
|
58 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related TEAEs · Yes
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related TEAEs · No
|
92 Participants
|
94 Participants
|
92 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious TEAEs · Yes
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious TEAEs · No
|
94 Participants
|
91 Participants
|
90 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related Serious TEAEs · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Stage A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Related Serious TEAEs · No
|
96 Participants
|
94 Participants
|
96 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post Second Dose (Day 180-Day 330 through Day 360)Population: The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received.
Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination. This analysis reports any AEs/SAEs that occurred after the second dose.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=39 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=41 Participants
High dose active in Stage A
|
Stage A: Placebo
n=37 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=41 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=43 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=43 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage B: Number of Participants With AEs and SAEs
Any TEAE · Yes
|
12 Participants
|
14 Participants
|
18 Participants
|
16 Participants
|
9 Participants
|
18 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Any TEAE · No
|
27 Participants
|
27 Participants
|
19 Participants
|
25 Participants
|
34 Participants
|
25 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Related TEAE · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Related TEAE · No
|
39 Participants
|
41 Participants
|
37 Participants
|
40 Participants
|
43 Participants
|
42 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Serious TEAE · Yes
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Serious TEAE · No
|
37 Participants
|
40 Participants
|
36 Participants
|
40 Participants
|
43 Participants
|
42 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Related Serious TEAE · Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage B: Number of Participants With AEs and SAEs
Related Serious TEAE · No
|
39 Participants
|
41 Participants
|
37 Participants
|
41 Participants
|
43 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Day 360Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=39 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=41 Participants
High dose active in Stage A
|
Stage A: Placebo
n=38 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=40 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=42 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=43 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage B: Change From Baseline in WOMAC Pain Score at Day 360
|
-3.4 score on a scale
Standard Error 0.666
|
-3.26 score on a scale
Standard Error 0.662
|
-3.44 score on a scale
Standard Error 0.682
|
-3.87 score on a scale
Standard Error 0.643
|
-2.9 score on a scale
Standard Error 0.659
|
-2.9 score on a scale
Standard Error 0.639
|
SECONDARY outcome
Timeframe: At Day 360Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=38 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=40 Participants
High dose active in Stage A
|
Stage A: Placebo
n=36 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=38 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=40 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=43 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage B: Change From Baseline in WOMAC Function Score
|
-11.23 score on a scale
Standard Error 2.236
|
-11.79 score on a scale
Standard Error 2.292
|
-12.8 score on a scale
Standard Error 2.330
|
-13.63 score on a scale
Standard Error 2.218
|
-9.44 score on a scale
Standard Error 2.292
|
-8.66 score on a scale
Standard Error 2.164
|
SECONDARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow.
The Brief Pain Inventory (BPI) is a self-administered questionnaire for participants to rate the degree to which their pain interferes with common dimensions of feeling and function. The 7 pain interference items will be rated on 0-10 scale. Total interference score ranges from 0 (does not interfere) to 10 (completely interferes); higher score indicates worse outcomes.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=95 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=95 Participants
High dose active in Stage A
|
Stage A: Placebo
n=96 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A: Change From Baseline in Brief Pain Inventory (BPI) of Interference Score
|
-0.96 score on a scale
Standard Error 0.263
|
-1.10 score on a scale
Standard Error 0.253
|
-1.46 score on a scale
Standard Error 0.258
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 180Population: The Intent-to-Treat (ITT) Population will comprise all enrolled participants who received the treatment injection, analyzed according to randomized Stage A treatment. The ITT Population will be the primary analysis population for efficacy. One (1) participant was randomized to 0.45 mg/ml XT-150 but inadvertently received 0.15 mg/ml XT-150 due to site error, explaining the difference between number analyzed in XT-150 groups compared to the overall participant flow.
The Patient Overall Assessment (POA) is a self-administered questionnaire that records participants' responses to the question "Considering all the ways the OA in your knee affects you, how are you doing today?" on a scale of 1 to 5; 1 being very good (asymptomatic and no limitation of normal activities) to 5, very poor (very severe, intolerable symptoms and inability to carry out normal activities). Higher score indicates worse symptoms.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=95 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=95 Participants
High dose active in Stage A
|
Stage A: Placebo
n=96 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A: Change From Baseline in Patients Overall Assessment (POA)
|
-0.19 score on a scale
Standard Error 0.102
|
-0.32 score on a scale
Standard Error 0.100
|
-0.33 score on a scale
Standard Error 0.098
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 360Population: The Safety Population will comprise all participants who receive any amount of study drug, analyzed according to treatment actually received.
Presence of Immunoglobulin M (IgM) or Immunoglobulin G (IgG) antibodies against human IL-10 in serum was assessed at Baseline/Day 0 and then post-initial dose on Days 7, 30, 60, 180, and 360.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=49 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=47 Participants
High dose active in Stage A
|
Stage A: Placebo
n=47 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=48 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=48 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Stage A and B: Number of Participants With Presence of Anti-interleukin (IL)-10 Antibody
Anti-IL-10 Antibodies Detected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Stage A and B: Number of Participants With Presence of Anti-interleukin (IL)-10 Antibody
No Anti-IL-10 Antibodies Detected
|
49 Participants
|
47 Participants
|
47 Participants
|
47 Participants
|
48 Participants
|
48 Participants
|
POST_HOC outcome
Timeframe: Day 360Population: The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (\>8). This is the target population of interest who may benefit most from the treatment.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. The data reported in this outcome measure is a head-to-head comparison of two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml and only includes these 2 treatment sequences whereas outcome measure #12 reports the least squared mean based on data for all 6 treatment sequences.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=36 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=29 Participants
High dose active in Stage A
|
Stage A: Placebo
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Post-Hoc WOMAC Pain Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT)
|
-5.02 score on a scale
Standard Error 0.815
|
-2.19 score on a scale
Standard Error 0.911
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Day 360Population: The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (\>8). This is the target population of interest who may benefit most from the treatment.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value. The data reported in this outcome measure is a head-to-head comparison of two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml and only includes these 2 treatment sequences whereas outcome measure #13 reports the least squared mean based on data for all 6 treatment sequences.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=36 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=29 Participants
High dose active in Stage A
|
Stage A: Placebo
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Post-Hoc WOMAC Function Score Change From Baseline - 2-dose 0.45mg XT-150 vs. Single-dose 0.45mg XT-150 (mITT)
|
-15.42 score on a scale
Standard Error 2.887
|
-5.82 score on a scale
Standard Error 3.201
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Day 360Population: The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (\>8). This is the target population of interest who may benefit most from the treatment.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score will be obtained from the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The score for pain category ranges from 0 (no pain) to 20 (maximum pain); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=35 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=35 Participants
High dose active in Stage A
|
Stage A: Placebo
n=39 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=36 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=36 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=29 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Post-Hoc WOMAC Pain Score Change From Baseline - All Dose Regimens (mITT)
|
-3.76 score on a scale
Standard Error 0.835
|
-3.53 score on a scale
Standard Error 0.800
|
-4.07 score on a scale
Standard Error 0.797
|
-4.93 score on a scale
Standard Error 0.789
|
-3.03 score on a scale
Standard Error 0.805
|
-2.42 score on a scale
Standard Error 0.852
|
POST_HOC outcome
Timeframe: Day 360Population: The Modified Intent-to-Treat population consists of the ITT population who received at least one treatment injection with a baseline WOMAC Pain score of 9-20 (\>8). This is the target population of interest who may benefit most from the treatment.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score will be obtained from the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire which is a is a validated, commonly used instrument to assess the participant's opinion about their knee and associated problems. Each item is answered on a 5-point Likert scale. The function dimension category asks about the degree of difficulty in doing 17 activities. The score ranges from 0 (normal function) to 170 (severely limited function); higher score indicates worse outcomes. Baseline is defined as the Day 0 value.
Outcome measures
| Measure |
Stage A: 0.15 mg/ml XT-150
n=35 Participants
Low dose active in Stage A
|
Stage A: 0.45 mg/ml XT-150
n=35 Participants
High dose active in Stage A
|
Stage A: Placebo
n=39 Participants
Inactive comparator in Stage A
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=36 Participants
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=36 Participants
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=29 Participants
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Post-Hoc WOMAC Function Score Change From Baseline - All Dose Regimens (mITT)
|
-12.73 score on a scale
Standard Error 2.810
|
-12.42 score on a scale
Standard Error 2.767
|
-13.95 score on a scale
Standard Error 2.695
|
-15.28 score on a scale
Standard Error 2.731
|
-9.33 score on a scale
Standard Error 2.848
|
-7.03 score on a scale
Standard Error 2.904
|
Adverse Events
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=49 participants at risk
Low dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 participants at risk
Low dose active in Stage A, high dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=47 participants at risk
High dose active in Stage A, low dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 participants at risk
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=48 participants at risk
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=48 participants at risk
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
Other adverse events
| Measure |
Stage A: 0.15 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=49 participants at risk
Low dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: 0.15 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 participants at risk
Low dose active in Stage A, high dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.15 mg/mL XT-150
n=47 participants at risk
High dose active in Stage A, low dose active in Stage B
XT-150: plasmid DNA
|
Stage A: 0.45 mg/mL XT-150, Stage B: 0.45 mg/mL XT-150
n=47 participants at risk
High dose active in Stage A and Stage B
XT-150: plasmid DNA
|
Stage A: Placebo, Stage B: 0.15 mg/mL XT-150
n=48 participants at risk
Inactive comparator in Stage A, low dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
Stage A: Placebo, Stage B: 0.45 mg/mL XT-150
n=48 participants at risk
Inactive comparator in Stage A, high dose active in Stage B
XT-150: plasmid DNA
Placebo: Placebo is a sterile phosphate-buffered saline
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
4/49 • Number of events 6 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
14.9%
7/47 • Number of events 8 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
19.1%
9/47 • Number of events 12 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
17.0%
8/47 • Number of events 9 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
14.6%
7/48 • Number of events 8 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
1/49 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
14.6%
7/48 • Number of events 11 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
8.5%
4/47 • Number of events 5 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
8.5%
4/47 • Number of events 5 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.2%
3/48 • Number of events 4 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Infections and infestations
Procedural pain
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Infections and infestations
COVID-19
|
4.1%
2/49 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
10.6%
5/47 • Number of events 5 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 4 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.2%
2/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
4.3%
2/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Nervous system disorders
Headache
|
2.0%
1/49 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/47 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 2 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.2%
3/48 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/49 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
6.4%
3/47 • Number of events 3 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
0.00%
0/48 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected from the time of informed consent through the last study visit on Day 360 (1 year). Treatment Emergent Adverse Events occurred from the time of study drug treatment on Day 0 through end of study (Day 360) or early termination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
- Publication restrictions are in place
Restriction type: OTHER