Trial Outcomes & Findings for B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis (NCT NCT04490109)
NCT ID: NCT04490109
Last Updated: 2025-01-28
Results Overview
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
547 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2025-01-28
Participant Flow
Participant milestones
| Measure |
B244 O.D. 5.0
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
187
|
|
Overall Study
Treated
|
180
|
180
|
186
|
|
Overall Study
COMPLETED
|
161
|
155
|
166
|
|
Overall Study
NOT COMPLETED
|
19
|
25
|
21
|
Reasons for withdrawal
| Measure |
B244 O.D. 5.0
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
9
|
|
Overall Study
Physician Decision
|
0
|
2
|
3
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Significant Non-Compliance
|
2
|
4
|
4
|
|
Overall Study
Significant Clinical Event
|
0
|
1
|
0
|
|
Overall Study
Other Reason
|
4
|
1
|
1
|
Baseline Characteristics
The population analyzed in this row represents only the participants who used a rescue medication.
Baseline characteristics by cohort
| Measure |
B244 O.D. 5.0
n=172 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=172 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=177 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
Total
n=521 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 12.93 • n=172 Participants
|
42.1 years
STANDARD_DEVIATION 13.49 • n=172 Participants
|
42.1 years
STANDARD_DEVIATION 13.15 • n=177 Participants
|
42.1 years
STANDARD_DEVIATION 13.17 • n=521 Participants
|
|
Age, Customized
18 to 40 years
|
78 Participants
n=172 Participants
|
80 Participants
n=172 Participants
|
74 Participants
n=177 Participants
|
232 Participants
n=521 Participants
|
|
Age, Customized
41 to 54 years
|
57 Participants
n=172 Participants
|
52 Participants
n=172 Participants
|
64 Participants
n=177 Participants
|
173 Participants
n=521 Participants
|
|
Age, Customized
55 to 65 years
|
37 Participants
n=172 Participants
|
40 Participants
n=172 Participants
|
39 Participants
n=177 Participants
|
116 Participants
n=521 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=172 Participants
|
111 Participants
n=172 Participants
|
122 Participants
n=177 Participants
|
351 Participants
n=521 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=172 Participants
|
61 Participants
n=172 Participants
|
55 Participants
n=177 Participants
|
170 Participants
n=521 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
87 Participants
n=172 Participants
|
88 Participants
n=172 Participants
|
85 Participants
n=177 Participants
|
260 Participants
n=521 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=172 Participants
|
84 Participants
n=172 Participants
|
92 Participants
n=177 Participants
|
261 Participants
n=521 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=172 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=521 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=172 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=521 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=172 Participants
|
18 Participants
n=172 Participants
|
21 Participants
n=177 Participants
|
58 Participants
n=521 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=172 Participants
|
0 Participants
n=172 Participants
|
1 Participants
n=177 Participants
|
1 Participants
n=521 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=172 Participants
|
41 Participants
n=172 Participants
|
39 Participants
n=177 Participants
|
116 Participants
n=521 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=172 Participants
|
111 Participants
n=172 Participants
|
114 Participants
n=177 Participants
|
338 Participants
n=521 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=172 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=177 Participants
|
0 Participants
n=521 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=172 Participants
|
2 Participants
n=172 Participants
|
2 Participants
n=177 Participants
|
8 Participants
n=521 Participants
|
|
Height
|
166.100 centimeters
STANDARD_DEVIATION 9.706 • n=172 Participants
|
165.608 centimeters
STANDARD_DEVIATION 9.923 • n=172 Participants
|
166.102 centimeters
STANDARD_DEVIATION 8.836 • n=177 Participants
|
165.938 centimeters
STANDARD_DEVIATION 9.479 • n=521 Participants
|
|
Weight
|
84.144 kilograms
STANDARD_DEVIATION 22.104 • n=172 Participants
|
81.351 kilograms
STANDARD_DEVIATION 19.603 • n=172 Participants
|
81.908 kilograms
STANDARD_DEVIATION 20.653 • n=177 Participants
|
82.462 kilograms
STANDARD_DEVIATION 20.805 • n=521 Participants
|
|
Body Mass Index (BMI)
|
30.576 kilograms/meters^2
STANDARD_DEVIATION 8.112 • n=172 Participants
|
29.610 kilograms/meters^2
STANDARD_DEVIATION 6.577 • n=172 Participants
|
29.729 kilograms/meters^2
STANDARD_DEVIATION 7.403 • n=177 Participants
|
29.969 kilograms/meters^2
STANDARD_DEVIATION 7.389 • n=521 Participants
|
|
Body Surface Area (BSA)
10-20%
|
108 Participants
n=172 Participants
|
113 Participants
n=172 Participants
|
118 Participants
n=177 Participants
|
339 Participants
n=521 Participants
|
|
Body Surface Area (BSA)
>20-30%
|
53 Participants
n=172 Participants
|
52 Participants
n=172 Participants
|
52 Participants
n=177 Participants
|
157 Participants
n=521 Participants
|
|
Body Surface Area (BSA)
>30-40%
|
11 Participants
n=172 Participants
|
7 Participants
n=172 Participants
|
7 Participants
n=177 Participants
|
25 Participants
n=521 Participants
|
|
Body Surface Area (BSA)
|
18.82 percentage of body surface
STANDARD_DEVIATION 7.247 • n=172 Participants
|
18.02 percentage of body surface
STANDARD_DEVIATION 6.069 • n=172 Participants
|
18.08 percentage of body surface
STANDARD_DEVIATION 6.600 • n=177 Participants
|
18.30 percentage of body surface
STANDARD_DEVIATION 6.653 • n=521 Participants
|
|
Smoking Status
Yes
|
30 Participants
n=172 Participants
|
28 Participants
n=172 Participants
|
29 Participants
n=177 Participants
|
87 Participants
n=521 Participants
|
|
Smoking Status
No
|
142 Participants
n=172 Participants
|
144 Participants
n=172 Participants
|
148 Participants
n=177 Participants
|
434 Participants
n=521 Participants
|
|
Rescue Medication
Yes
|
30 Participants
n=172 Participants
|
27 Participants
n=172 Participants
|
33 Participants
n=177 Participants
|
90 Participants
n=521 Participants
|
|
Rescue Medication
No
|
142 Participants
n=172 Participants
|
145 Participants
n=172 Participants
|
144 Participants
n=177 Participants
|
431 Participants
n=521 Participants
|
|
Rescue Medication Days
|
1.4 days
STANDARD_DEVIATION 0.72 • n=30 Participants • The population analyzed in this row represents only the participants who used a rescue medication.
|
1.3 days
STANDARD_DEVIATION 0.78 • n=27 Participants • The population analyzed in this row represents only the participants who used a rescue medication.
|
1.7 days
STANDARD_DEVIATION 1.85 • n=33 Participants • The population analyzed in this row represents only the participants who used a rescue medication.
|
1.5 days
STANDARD_DEVIATION 1.26 • n=90 Participants • The population analyzed in this row represents only the participants who used a rescue medication.
|
|
Worst Itch Numeric Rating Scale (WI-NRS)
|
8.21 score on a scale
STANDARD_DEVIATION 0.913 • n=172 Participants
|
8.26 score on a scale
STANDARD_DEVIATION 1.004 • n=172 Participants
|
8.26 score on a scale
STANDARD_DEVIATION 1.094 • n=177 Participants
|
8.24 score on a scale
STANDARD_DEVIATION 1.006 • n=521 Participants
|
|
Average Itch Numeric Rating Scale (AI-NRS)
|
7.53 score on a scale
STANDARD_DEVIATION 1.062 • n=172 Participants
|
7.42 score on a scale
STANDARD_DEVIATION 1.344 • n=172 Participants
|
7.39 score on a scale
STANDARD_DEVIATION 1.374 • n=177 Participants
|
7.45 score on a scale
STANDARD_DEVIATION 1.268 • n=521 Participants
|
|
5-D Pruritus Scale Total Score
|
17.0 score on a scale
STANDARD_DEVIATION 2.59 • n=172 Participants
|
16.6 score on a scale
STANDARD_DEVIATION 2.86 • n=172 Participants
|
17.0 score on a scale
STANDARD_DEVIATION 2.89 • n=177 Participants
|
16.9 score on a scale
STANDARD_DEVIATION 2.79 • n=521 Participants
|
|
Eczema Area Severity Index (EASI)
<=10
|
125 Participants
n=172 Participants
|
116 Participants
n=172 Participants
|
122 Participants
n=177 Participants
|
363 Participants
n=521 Participants
|
|
Eczema Area Severity Index (EASI)
>10
|
47 Participants
n=172 Participants
|
56 Participants
n=172 Participants
|
55 Participants
n=177 Participants
|
158 Participants
n=521 Participants
|
|
Eczema Area Severity Index (EASI) Total Score
|
9.23 score on a scale
STANDARD_DEVIATION 5.463 • n=172 Participants
|
8.98 score on a scale
STANDARD_DEVIATION 4.321 • n=172 Participants
|
8.92 score on a scale
STANDARD_DEVIATION 4.560 • n=177 Participants
|
9.04 score on a scale
STANDARD_DEVIATION 4.797 • n=521 Participants
|
|
Investigator's Global Assessment (IGA)
Mild
|
53 Participants
n=172 Participants
|
53 Participants
n=172 Participants
|
48 Participants
n=177 Participants
|
154 Participants
n=521 Participants
|
|
Investigator's Global Assessment (IGA)
Moderate
|
117 Participants
n=172 Participants
|
119 Participants
n=172 Participants
|
129 Participants
n=177 Participants
|
365 Participants
n=521 Participants
|
|
Investigator's Global Assessment (IGA)
Severe
|
2 Participants
n=172 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=177 Participants
|
2 Participants
n=521 Participants
|
|
Investigator's Global Assessment (IGA)
|
2.7 score on a scale
STANDARD_DEVIATION 0.48 • n=172 Participants
|
2.7 score on a scale
STANDARD_DEVIATION 0.46 • n=172 Participants
|
2.7 score on a scale
STANDARD_DEVIATION 0.45 • n=177 Participants
|
2.7 score on a scale
STANDARD_DEVIATION 0.46 • n=521 Participants
|
|
Patient Oriented Eczema Measure (POEM) Total Score
|
16.6 score on a scale
STANDARD_DEVIATION 5.03 • n=172 Participants
|
15.7 score on a scale
STANDARD_DEVIATION 4.88 • n=172 Participants
|
16.1 score on a scale
STANDARD_DEVIATION 5.49 • n=177 Participants
|
16.1 score on a scale
STANDARD_DEVIATION 5.14 • n=521 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=165 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=174 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)
|
-2.8 score on a scale
Standard Error 0.184
|
-2.8 score on a scale
Standard Error 0.184
|
-2.1 score on a scale
Standard Error 0.180
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28.
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=165 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=174 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Patients With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
|
51 Participants
|
51 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=165 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=174 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With Any Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
|
120 Participants
|
115 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=165 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=172 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Average Itch Numeric Rating Scale (AI-NRS)
|
-2.7 score on a scale
Standard Error .132
|
-2.7 score on a scale
Standard Error .132
|
-2.1 score on a scale
Standard Error .164
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=165 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=172 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With ≥4 Point Improvement in Average Itch Numeric Rating Scale (AI-NRS)
|
54 Participants
|
53 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Average itch intensity (AI-NRS) during a 24-hour recall period will be captured. The question for AI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your average level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=165 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=172 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With Any Improvement in Average Itch Numeric Rating Scale (AI-NRS)
|
118 Participants
|
112 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 14
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=170 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=172 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=174 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Worst Itch Numeric Rating Scale (WI-NRS)
|
-2.0 score on a scale
Standard Error .138
|
-2.0 score on a scale
Standard Error .137
|
-1.5 score on a scale
Standard Error .170
|
SECONDARY outcome
Timeframe: Baseline to Day 14Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 14
The Itch Numeric Rating Scale (I-NRS) is a validated, self-reported instrument for measurement of itch intensity. It uses a 24-hour recall period and asks subjects to rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. Worst itch intensity (WI-NRS) during a 24-hour recall period will be captured. The question for WI-NRS would be, "Please rate the itching severity due to your atopic dermatitis by circling the number that best describes your worst level of itching in the past 24 hours."
Outcome measures
| Measure |
B244 O.D. 5.0
n=170 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=172 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=174 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With ≥4 Point Improvement in Worst Itch Numeric Rating Scale (WI-NRS)
|
34 Participants
|
30 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
The Patient Oriented Eczema Measure (POEM) is a tool developed by the University of Nottingham, United Kingdom, for monitoring atopic dermatitis severity. The subject will complete the questionnaire at each of the assessment timepoints as outlined. Each of the 7 questions in the POEM questionnaire carries equal weight and is scored from 0 to 4: No days = 0. 1 to 2 days = 1. 3 to 4 days = 2. 5 to 6 days = 3. Every day = 4. Scores are then added to yield a total score of 0 to 28; higher scores mean the greater the severity of atopic dermatitis.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Patient Oriented Eczema Measure (POEM)
|
-6.4 score on a scale
Standard Error .342
|
-6.0 score on a scale
Standard Error .343
|
-5.2 score on a scale
Standard Error .394
|
SECONDARY outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28.
The 5-D Pruritus Scale is a validated, multi-dimensional measure of itching that assesses the five domains of degree (score 1-5: 1=not present, 2=mild, 3=moderate, 4=severe, 5=unbearable), duration (score 1-5: 1=less than 6hrs/day, 2=6-12hrs/day, 3=12-18hrs/day, 4=18-23hrs/day, 5=all day), direction (score 1-5: 1=completely resolved, 2=much better/still present, 3=little bit better/still present, 4=unchanged, 5=getting worse), disability (score 1-5: 1=never affects activity, 2=rarely affects activity, 3=occasionally affects activity, 4=frequently affects activity, 5=always affects activity; highest activity score is taken), and distribution (check boxes of affected body parts; 0-2 body parts=score of 1, 3-5=score of 2, 6-10=score of 3, 11-13=score of 4, 14-16=score of 5). The domains are scored separately and then summed together to obtain a total 5-D score, ranging from 5 (no pruritus) to 25 (most severe pruritus). Subjects rate their symptoms over the preceding 2-week period.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in 5-D Pruritus Scale
|
-5.2 score on a scale
Standard Error .228
|
-5.2 score on a scale
Standard Error .229
|
-4.2 score on a scale
Standard Error .262
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Investigator's Global Assessment (IGA) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Investigator's Global Assessment (IGA)
|
-0.8 score on a scale
Standard Error .056
|
-0.8 score on a scale
Standard Error .056
|
-0.5 score on a scale
Standard Error .064
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Eczema Area Severity Index (EASI) is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Mean Change in Eczema Area Severity Index (EASI)
|
-3.9 score on a scale
Standard Error .249
|
-4.0 score on a scale
Standard Error .250
|
-3.1 score on a scale
Standard Error .289
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Investigator's Global Assessment (IGA) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear and ≥2 Point Improvement
|
36 Participants
|
43 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Investigator's Global Assessment (IGA) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With Investigator's Global Assessment (IGA) of Clear or Almost Clear at Week 4
|
46 Participants
|
62 Participants
|
34 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Investigator's Global Assessment (IGA) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease).
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With Any Improvement in Investigator's Global Assessment (IGA) From Baseline to Week 4
|
81 Participants
|
91 Participants
|
73 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Eczema Area Severity Index (EASI) is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With ≥50% Improvement in Eczema Area Severity Index (EASI-50)
|
74 Participants
|
76 Participants
|
60 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Eczema Area Severity Index (EASI) is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With ≥75% Improvement in Eczema Area Severity Index (EASI-75)
|
46 Participants
|
48 Participants
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 28Population: Subjects from the Modified Intent to Treat (mITT) population (all randomized participants who applied at least 1 dose of study medication and had at least one post-baseline evaluation on-site visit. Subjects were grouped as randomized) that remained in the study at Day 28
Eczema Area Severity Index (EASI) is a validated tool used to measure the severity and extent of atopic dermatitis where clinical investigators assess the presence and severity of erythema, edema/papulation, excoriation, and lichenification (score 0-3: none=0, mild=1, moderate=2, severe=3, half-points allowed) and area of involvement (score 0-6: 0=0% involvement, 1=1-9% involvement, 2=10-29% involvement, 3=30-49% involvement, 4=50-69% involvement, 5=70-89% involvement, 6=90-100% involvement) across head and neck, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks). The EASI score can range from 0.0 to 72.0 with increments of 0.1 and higher scores representing a greater severity of atopic dermatitis.
Outcome measures
| Measure |
B244 O.D. 5.0
n=166 Participants
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=164 Participants
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=171 Participants
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Proportion of Subjects With ≥90% Improvement in Eczema Area Severity Index (EASI-90)
|
25 Participants
|
30 Participants
|
10 Participants
|
Adverse Events
B244 O.D. 5.0
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
B244 O.D. 20.0
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B244 O.D. 5.0
n=180 participants at risk
B244 suspension (1x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
B244 O.D. 20.0
n=180 participants at risk
B244 suspension (4x10E10 cells/ml) in 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
B244: B244 suspension
|
Vehicle
n=186 participants at risk
Vehicle, 30ml/bottle
Subjects will apply a total of 10 pumps of IP per application to all affected areas twice-a-day
Vehicle: Vehicle suspension
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Nausea
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Gastrointestinal disorders
Toothache
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Application site dryness
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Application site erythema
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Application site pain
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Application site pruritus
|
1.7%
3/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Application site rash
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Fatigue
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Pyrexia
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
General disorders
Vaccination site discomfort
|
1.7%
3/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Immune system disorders
Food allergy
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
COVID-19
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.7%
3/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Hordeolum
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Influenza
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Nasopharyngitis
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Investigations
Hepatic enzyme increased
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
2.2%
4/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.7%
3/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Nervous system disorders
Headache
|
3.3%
6/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
2.2%
4/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
1.1%
2/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.54%
1/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
|
Vascular disorders
Hypertension
|
0.56%
1/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/180 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
0.00%
0/186 • Screening visit to Week 8.
All adverse events (AEs) occurring after signing of the ICF through study completion/early termination were to be reported. All AEs were to be recorded irrespective of whether they were considered drug related. AEs were to be evaluated by the Investigator at each visit for duration, intensity, and whether the event could have been associated with the IP or other causes. AEs believed to be possibly related to IP must have been followed until their resolution.
|
Additional Information
Hyun Kim, Vice President Clinical Operations
AOBiome Therapeutics
Phone: 617-639-9980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall have 60 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional 90 days to enable Sponsor to seek patent protections.
- Publication restrictions are in place
Restriction type: OTHER