Trial Outcomes & Findings for Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy (NCT NCT01675882)
NCT ID: NCT01675882
Last Updated: 2021-10-27
Results Overview
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
At Month 12
Results posted on
2021-10-27
Participant Flow
This Phase IIb, placebo-controlled study was conducted in participants aged 6 to 55 years old with peanut allergy at 22 study centers in 5 countries (Canada, France, Netherlands, Poland and USA) between 31 July 2012 and 31 July 2014. All participants who completed the VIPES study up to Visit 11 (inclusive) were eligible for participation in the follow-up study (OLFUS-VIPES).
Study had a 4-week screening period, 52-week treatment period and 2-week follow-up period. A total of 221 participants were randomized in a 1:1:1:1 ratio into 4 treatment groups (50 micrograms \[μg\], 100 μg, 250 μg peanut proteins and placebo). Each participant underwent dose-escalating double-blind, placebo-controlled food challenge (DBPCFC) at screening and Month 12. At screening, a dose-escalating DBPCFC confirmed peanut allergy to an eliciting dose \<=300 milligrams (mg) peanut protein.
Participant milestones
| Measure |
Viaskin Peanut 50 μg
Participants applied 1 new Viaskin® Peanut (DBV712) 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
56
|
56
|
56
|
|
Overall Study
COMPLETED
|
51
|
49
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
3
|
2
|
Reasons for withdrawal
| Measure |
Viaskin Peanut 50 μg
Participants applied 1 new Viaskin® Peanut (DBV712) 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
0
|
|
Overall Study
Participant unwilling to continue
|
2
|
4
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
Baseline characteristics by cohort
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.3 years
STANDARD_DEVIATION 6.72 • n=5 Participants
|
13.9 years
STANDARD_DEVIATION 6.66 • n=7 Participants
|
13.6 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
12.5 years
STANDARD_DEVIATION 6.84 • n=4 Participants
|
13.1 years
STANDARD_DEVIATION 6.92 • n=21 Participants
|
|
Age, Customized
Children (6-11 years)
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Age, Customized
Adults (18-55 years)
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
138 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not applicable
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Percentage of Treatment Responders at Month 12; Analyzed in Overall Population
|
45.3 percentage of participants
Interval 31.56 to 59.55
|
41.1 percentage of participants
Interval 28.1 to 55.02
|
50.0 percentage of participants
Interval 36.34 to 63.66
|
25.0 percentage of participants
Interval 14.39 to 38.37
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=26 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=31 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Percentage of Treatment Responders at Month 12; Analyzed in Children (6-11 Years of Age)
|
57.1 percentage of participants
Interval 37.18 to 75.54
|
46.2 percentage of participants
Interval 26.59 to 66.63
|
53.6 percentage of participants
Interval 33.87 to 72.49
|
19.4 percentage of participants
Interval 7.45 to 37.47
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=19 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=18 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Percentage of Treatment Responders at Month 12; Analyzed in Adolescents (12-17 Years of Age)
|
33.3 percentage of participants
Interval 13.34 to 59.01
|
10.5 percentage of participants
Interval 1.3 to 33.14
|
38.9 percentage of participants
Interval 17.3 to 64.25
|
22.2 percentage of participants
Interval 6.41 to 47.64
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=7 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=11 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=10 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=7 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Percentage of Treatment Responders at Month 12; Analyzed in Adults (18-55 Years of Age)
|
28.6 percentage of participants
Interval 3.67 to 70.96
|
81.8 percentage of participants
Interval 48.22 to 97.72
|
60.0 percentage of participants
Interval 26.24 to 87.84
|
57.1 percentage of participants
Interval 18.41 to 90.1
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized.
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at the screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Overall Population
|
453.8 mg
Standard Deviation 608.16
|
539.7 mg
Standard Deviation 659.31
|
621.4 mg
Standard Deviation 715.03
|
283.7 mg
Standard Deviation 482.04
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=26 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=31 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Children (6-11 Years of Age)
|
397.1 mg
Standard Deviation 510.13
|
441.2 mg
Standard Deviation 511.26
|
652.5 mg
Standard Deviation 766.93
|
160.5 mg
Standard Deviation 244.00
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=19 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=18 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adolescents (12-17 Years of Age)
|
501.7 mg
Standard Deviation 726.14
|
281.6 mg
Standard Deviation 472.47
|
573.9 mg
Standard Deviation 716.01
|
331.8 mg
Standard Deviation 511.62
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
The peanut protein eliciting dose was defined as the first dose of peanut protein administered to the participant during the DBPCFC procedure which caused an objective allergic reaction. This was capped to 300 mg at screening DBPCFC and to 2000 mg at the Month 12 DBPCFC. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=7 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=11 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=10 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=7 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Mean Eliciting Doses of Peanut Proteins at Month 12; Analyzed in Adults (18-55 Years of Age)
|
557.1 mg
Standard Deviation 711.47
|
1218.5 mg
Standard Deviation 822.74
|
620.0 mg
Standard Deviation 619.68
|
705.7 mg
Standard Deviation 893.01
|
SECONDARY outcome
Timeframe: At Month 12Population: The full analysis set included all participants who were randomized.
The peanut protein cumulative reactive dose was defined as the sum of all peanut protein doses up to and including the eliciting dose ingested during the peanut challenge. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Mean Cumulative Reactive Dose of Peanut Proteins at Month 12; Analyzed in Overall Population
|
730.8 mg
Standard Deviation 1020.53
|
863.5 mg
Standard Deviation 1120.43
|
1010.6 mg
Standard Deviation 1223.85
|
451.4 mg
Standard Deviation 807.13
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: The full analysis set included all participants who were randomized.
The symptoms of erythematous rash, pruritus, urticaria/angioedema, rash, sneezing/itching, nasal congestion, rhinorrhea, laryngeal symptoms (example, throat clearing, occasional cough, hoarseness, frequent dry cough, inspiratory stridor), wheezing, subjective complaints, objective complaints and cardiovascular symptoms (example, color change, weakness, dizziness, mental status change, tachycardia, decreased blood pressure, etc) were observed. The OFC score ranges from 0 to 3 for each symptom (0=Absent, 1=mild, 2=moderate or 3=severe). The total symptom score for each participant was calculated. Higher scores indicate worst outcome. For participants with missing treatment response at Month 12, LOCF imputation was used (i.e., participants were considered as non-responders).
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Severity of Symptoms Based on the Oral Food Challenge (OFC) Symptom Score Sheet at Month 12; Analyzed in Overall Population
|
-1.9 units on a scale
Standard Deviation 4.79
|
-0.9 units on a scale
Standard Deviation 4.21
|
0.2 units on a scale
Standard Deviation 4.65
|
-1.4 units on a scale
Standard Deviation 4.35
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized.
The mean wheal diameter of skin prick test (sum of the orthogonal diameters divided by 2) at each time point is calculated for the 5 skin prick tests at baseline and at each time point, i.e., Months 3, 6 and 12: undiluted, diluted 1:10 millimeter (mm), diluted 1:100 (mm), diluted 1:1,000 (mm), diluted 1:10,000 (mm). The ratio of the mean wheal diameter at each time point for a specific dilution versus the baseline value for that specific dilution was calculated and classified as \<=0.5 or \>0.5, allowing to assess the number of participants of those mean wheal diameters that have been at least halved from the baseline value.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:10); > 0.5
|
43 Participants
|
51 Participants
|
48 Participants
|
52 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:10000); <= 0.5
|
21 Participants
|
17 Participants
|
22 Participants
|
15 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: undiluted; <= 0.5
|
7 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: undiluted; > 0.5
|
46 Participants
|
47 Participants
|
51 Participants
|
52 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:10); <= 0.5
|
10 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:100); <= 0.5
|
13 Participants
|
12 Participants
|
15 Participants
|
6 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:100); > 0.5
|
39 Participants
|
43 Participants
|
41 Participants
|
50 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:1000); <= 0.5
|
13 Participants
|
15 Participants
|
24 Participants
|
12 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:1000); > 0.5
|
35 Participants
|
35 Participants
|
28 Participants
|
40 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 3: diluted (1:10000); > 0.5
|
21 Participants
|
18 Participants
|
20 Participants
|
24 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: undiluted; <= 0.5
|
14 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: undiluted; > 0.5
|
39 Participants
|
49 Participants
|
49 Participants
|
54 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:10); <= 0.5
|
9 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:10); > 0.5
|
44 Participants
|
46 Participants
|
47 Participants
|
51 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:100); <= 0.5
|
15 Participants
|
16 Participants
|
14 Participants
|
4 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:100); > 0.5
|
37 Participants
|
39 Participants
|
42 Participants
|
52 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:1000); <= 0.5
|
15 Participants
|
11 Participants
|
23 Participants
|
11 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:1000); > 0.5
|
33 Participants
|
39 Participants
|
29 Participants
|
41 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:10000); <= 0.5
|
21 Participants
|
15 Participants
|
22 Participants
|
14 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 6: diluted (1:10000); > 0.5
|
21 Participants
|
20 Participants
|
20 Participants
|
25 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: undiluted; <= 0.5
|
8 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: undiluted; > 0.5
|
45 Participants
|
52 Participants
|
49 Participants
|
54 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:10); <= 0.5
|
10 Participants
|
6 Participants
|
15 Participants
|
3 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:10); > 0.5
|
43 Participants
|
50 Participants
|
41 Participants
|
53 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:100); <= 0.5
|
11 Participants
|
14 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:100); > 0.5
|
41 Participants
|
41 Participants
|
43 Participants
|
49 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:1000); <= 0.5
|
14 Participants
|
9 Participants
|
18 Participants
|
8 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:1000); > 0.5
|
34 Participants
|
41 Participants
|
34 Participants
|
44 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:10000); <= 0.5
|
22 Participants
|
14 Participants
|
24 Participants
|
13 Participants
|
|
Number of Participants With an Average Wheal Diameter Ratio ≤0.5 and >0.5 at Each Skin Prick Test Dilution at Months 3, 6 and 12; Analyzed in Overall Population
Month 12: diluted (1:10000); > 0.5
|
20 Participants
|
21 Participants
|
18 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized.
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
Month 3
|
32.3 kilo units per liter (kU/L)
Interval -375.0 to 676.0
|
29.9 kilo units per liter (kU/L)
Interval -118.0 to 1243.0
|
50.7 kilo units per liter (kU/L)
Interval -91.0 to 794.0
|
2.8 kilo units per liter (kU/L)
Interval -117.0 to 445.0
|
|
Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
Month 6
|
8.8 kilo units per liter (kU/L)
Interval -158.0 to 348.0
|
22.0 kilo units per liter (kU/L)
Interval -65.0 to 1464.0
|
29.5 kilo units per liter (kU/L)
Interval -93.0 to 747.0
|
-1.1 kilo units per liter (kU/L)
Interval -363.0 to 79.0
|
|
Change From Baseline in Peanut-Specific Immunoglobulin E (IgE) at Months 3, 6 and 12; Analyzed in Overall Population
Month 12
|
-0.2 kilo units per liter (kU/L)
Interval -211.0 to 305.0
|
4.9 kilo units per liter (kU/L)
Interval -146.0 to 245.0
|
5.2 kilo units per liter (kU/L)
Interval -382.0 to 598.0
|
-1.4 kilo units per liter (kU/L)
Interval -327.0 to 93.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=26 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=31 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 3
|
63.6 kU/L
Interval -375.0 to 676.0
|
63.1 kU/L
Interval -27.0 to 1243.0
|
50.7 kU/L
Interval -16.0 to 794.0
|
4.1 kU/L
Interval -117.0 to 445.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 6
|
10.6 kU/L
Interval -55.0 to 348.0
|
48.7 kU/L
Interval -9.0 to 1464.0
|
21.2 kU/L
Interval -70.0 to 291.0
|
-1.8 kU/L
Interval -363.0 to 79.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 12
|
-3.1 kU/L
Interval -211.0 to 305.0
|
3.5 kU/L
Interval -146.0 to 150.0
|
1.0 kU/L
Interval -136.0 to 485.0
|
-12.0 kU/L
Interval -327.0 to 59.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=19 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=18 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 3
|
11.5 kU/L
Interval -99.0 to 248.0
|
62.0 kU/L
Interval -118.0 to 303.0
|
135.5 kU/L
Interval 0.0 to 552.0
|
4.8 kU/L
Interval -17.0 to 232.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 6
|
6.0 kU/L
Interval -158.0 to 170.0
|
24.2 kU/L
Interval -65.0 to 239.0
|
90.0 kU/L
Interval -10.0 to 440.0
|
0.0 kU/L
Interval -43.0 to 75.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 12
|
5.2 kU/L
Interval -49.0 to 199.0
|
24.9 kU/L
Interval -98.0 to 163.0
|
39.4 kU/L
Interval -382.0 to 434.0
|
1.0 kU/L
Interval -31.0 to 93.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgE at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=7 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=11 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=10 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=7 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 6
|
34.4 kU/L
Interval 0.0 to 214.0
|
3.6 kU/L
Interval -4.0 to 377.0
|
1.6 kU/L
Interval -93.0 to 747.0
|
-0.2 kU/L
Interval -42.0 to 40.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 3
|
65.3 kU/L
Interval -76.0 to 183.0
|
12.3 kU/L
Interval -1.0 to 169.0
|
3.1 kU/L
Interval -91.0 to 471.0
|
0.1 kU/L
Interval -34.0 to 13.0
|
|
Change From Baseline in Peanut-Specific IgE at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 12
|
22.3 kU/L
Interval -25.0 to 163.0
|
0.3 kU/L
Interval -9.0 to 245.0
|
-2.0 kU/L
Interval -148.0 to 598.0
|
0.9 kU/L
Interval -107.0 to 39.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized.
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=53 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
Month 3
|
0.4 mg per liter (mg/L)
Interval -1.0 to 6.0
|
0.4 mg per liter (mg/L)
Interval -18.0 to 4.0
|
0.8 mg per liter (mg/L)
Interval -1.0 to 14.0
|
0.0 mg per liter (mg/L)
Interval -3.0 to 2.0
|
|
Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
Month 6
|
0.8 mg per liter (mg/L)
Interval -2.0 to 6.0
|
0.8 mg per liter (mg/L)
Interval -19.0 to 8.0
|
1.4 mg per liter (mg/L)
Interval -6.0 to 19.0
|
0.0 mg per liter (mg/L)
Interval -2.0 to 3.0
|
|
Change From Baseline in Peanut-Specific Immunoglobulin G Subtype 4 (IgG4) at Months 3, 6 and 12; Analyzed in Overall Population
Month 12
|
1.0 mg per liter (mg/L)
Interval -2.0 to 12.0
|
0.9 mg per liter (mg/L)
Interval -9.0 to 10.0
|
1.6 mg per liter (mg/L)
Interval -3.0 to 17.0
|
0.0 mg per liter (mg/L)
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 6-11 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=26 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=28 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=31 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 3
|
0.6 mg/L
Interval -1.0 to 6.0
|
0.4 mg/L
Interval -18.0 to 4.0
|
1.7 mg/L
Interval -1.0 to 14.0
|
0.0 mg/L
Interval -1.0 to 1.0
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 6
|
1.1 mg/L
Interval -2.0 to 6.0
|
1.1 mg/L
Interval -19.0 to 8.0
|
4.4 mg/L
Interval 0.0 to 19.0
|
-0.1 mg/L
Interval -1.0 to 2.0
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Children (6-11 Years of Age)
Month 12
|
2.0 mg/L
Interval -2.0 to 12.0
|
1.6 mg/L
Interval -9.0 to 10.0
|
6.3 mg/L
Interval -1.0 to 17.0
|
-0.0 mg/L
Interval -2.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 12-17 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=19 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=18 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=18 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 3
|
0.1 mg/L
Interval 0.0 to 2.0
|
0.6 mg/L
Interval 0.0 to 2.0
|
0.7 mg/L
Interval 0.0 to 4.0
|
0.1 mg/L
Interval -3.0 to 2.0
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 6
|
0.3 mg/L
Interval -1.0 to 3.0
|
0.8 mg/L
Interval 0.0 to 2.0
|
0.7 mg/L
Interval -6.0 to 6.0
|
0.1 mg/L
Interval -2.0 to 3.0
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adolescents (12-17 Years of Age)
Month 12
|
0.4 mg/L
Interval -1.0 to 8.0
|
0.7 mg/L
Interval -1.0 to 3.0
|
0.9 mg/L
Interval -3.0 to 9.0
|
0.1 mg/L
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and Months 3, 6 and 12Population: The full analysis set included all participants who were randomized. Only participants in the range of 18-55 years of age are reported.
Venous blood samples were taken for assessment of the peanut-specific IgG4 at 3, 6 and 12 months. Results are presented using multiple imputation to replace missing values.
Outcome measures
| Measure |
Viaskin Peanut 50 μg
n=7 Participants
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=11 Participants
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=10 Participants
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=7 Participants
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 3
|
0.2 mg/L
Interval 0.0 to 3.0
|
0.5 mg/L
Interval 0.0 to 2.0
|
0.4 mg/L
Interval 0.0 to 1.0
|
0.1 mg/L
Interval 0.0 to 0.4
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 6
|
0.5 mg/L
Interval 0.0 to 3.0
|
0.5 mg/L
Interval 0.0 to 1.0
|
0.6 mg/L
Interval 0.0 to 6.0
|
0.0 mg/L
Interval 0.0 to 1.0
|
|
Change From Baseline in Peanut-Specific IgG4 at Months 3, 6 and 12; Analyzed in Adults (18-55 Years of Age)
Month 12
|
0.6 mg/L
Interval 0.0 to 3.0
|
0.3 mg/L
Interval 0.0 to 1.0
|
0.9 mg/L
Interval 0.0 to 8.0
|
0.1 mg/L
Interval 0.0 to 0.4
|
Adverse Events
Viaskin Peanut 50 μg
Serious events: 2 serious events
Other events: 53 other events
Deaths: 0 deaths
Viaskin Peanut 100 μg
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Viaskin Peanut 250 μg
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Viaskin Peanut 50 μg
n=53 participants at risk
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 participants at risk
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 participants at risk
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
3.8%
2/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Viaskin Peanut 50 μg
n=53 participants at risk
Participants applied 1 new Viaskin Peanut 50 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 100 μg
n=56 participants at risk
Participants applied 1 new Viaskin Peanut 100 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Viaskin Peanut 250 μg
n=56 participants at risk
Participants applied 1 new Viaskin Peanut 250 μg patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
Placebo
n=56 participants at risk
Participants applied 1 new placebo patch on intact skin for 24 hours daily for 12 months. To better ensure the safety of the patch at the initiation of treatment, the application duration was progressively increased to a duration of 24 hours daily over a 21-day graduated dosing period.
|
|---|---|---|---|---|
|
General disorders
Application site discolouration
|
1.9%
1/53 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site irritation
|
3.8%
2/53 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Eye disorders
Eye swelling
|
1.9%
1/53 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.4%
5/53 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
2/53 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
5/53 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
5/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pruritus
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site erythema
|
73.6%
39/53 • Number of events 53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
58.9%
33/56 • Number of events 68 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
57.1%
32/56 • Number of events 61 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
25.0%
14/56 • Number of events 21 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site pruritus
|
34.0%
18/53 • Number of events 23 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
41.1%
23/56 • Number of events 52 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
41.1%
23/56 • Number of events 38 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 15 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
17.0%
9/53 • Number of events 15 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
17.9%
10/56 • Number of events 12 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site eczema
|
13.2%
7/53 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 12 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
17.9%
10/56 • Number of events 17 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site swelling
|
9.4%
5/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
21.4%
12/56 • Number of events 15 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site papules
|
11.3%
6/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
16.1%
9/56 • Number of events 12 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site dermatitis
|
9.4%
5/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site rash
|
13.2%
7/53 • Number of events 11 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site reaction
|
3.8%
2/53 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site urticaria
|
3.8%
2/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site oedema
|
1.9%
1/53 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site pain
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Application site dryness
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Food allergy
|
15.1%
8/53 • Number of events 11 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
19.6%
11/56 • Number of events 22 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 11 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
17.9%
10/56 • Number of events 14 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
9.4%
5/53 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
7.5%
4/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.4%
14/53 • Number of events 23 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
19.6%
11/56 • Number of events 18 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
21.4%
12/56 • Number of events 17 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
21.4%
12/56 • Number of events 25 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
22.6%
12/53 • Number of events 13 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
16.1%
9/56 • Number of events 17 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
17.9%
10/56 • Number of events 15 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
32.1%
18/56 • Number of events 30 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
2/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
5.7%
3/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
11.3%
6/53 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.7%
3/53 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
1.9%
1/53 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.8%
2/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
9.4%
5/53 • Number of events 8 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
7.5%
4/53 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.7%
3/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
1/53 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/53 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
20.8%
11/53 • Number of events 17 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 16 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 14 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
23.2%
13/56 • Number of events 27 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
6/53 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 15 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.3%
6/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
16.1%
9/56 • Number of events 14 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 12 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.3%
6/53 • Number of events 11 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
10.7%
6/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.5%
4/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.4%
5/53 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
12.5%
7/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.5%
4/53 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 10 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
1/53 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.7%
3/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
15.1%
8/53 • Number of events 16 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 9 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
14.3%
8/56 • Number of events 18 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.3%
6/53 • Number of events 6 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
5.4%
3/56 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 7 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
4/53 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
8.9%
5/56 • Number of events 5 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
7.1%
4/56 • Number of events 4 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
3/53 • Number of events 3 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
3.6%
2/56 • Number of events 2 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
1.8%
1/56 • Number of events 1 • Treatment-emergent adverse events were collected from Day 1, throughout the 52-week treatment period and additional 2-week follow-up period. Overall time frame of up to 54 weeks.
The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place