Trial Outcomes & Findings for A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines (NCT NCT03907878)
NCT ID: NCT03907878
Last Updated: 2025-03-06
Results Overview
Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks) An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
64 weeks
Results posted on
2025-03-06
Participant Flow
66 participants enrolled at 11 sites in Japan
Safety Set included all subjects who received at least one dose of study treatment.
Participant milestones
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Treatment Period
STARTED
|
66
|
|
Treatment Period
COMPLETED
|
55
|
|
Treatment Period
NOT COMPLETED
|
11
|
|
Follow-up Period
STARTED
|
66
|
|
Follow-up Period
COMPLETED
|
60
|
|
Follow-up Period
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Treatment Period
Withdrawal by Subject
|
5
|
|
Treatment Period
Adverse Event
|
4
|
|
Treatment Period
Lack of Efficacy
|
1
|
|
Treatment Period
Protocol Violation
|
1
|
|
Follow-up Period
Adverse Event
|
3
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
Baseline Characteristics
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
Baseline characteristics by cohort
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 13.18 • n=99 Participants
|
|
Age, Customized
< 18 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Between 18 and 65 years
|
59 Participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
66 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 64 weeksPopulation: Safety Set included all subjects who received at least one dose of study treatment.
Participants with treatment emergent adverse events (AEs) and serious adverse events (SAEs) summary for entire study (64 weeks) An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Any AEs
|
53 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Treatment-related AEs
|
11 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Severe AEs
|
0 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Moderate AEs
|
13 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
Deaths
|
0 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
SAEs
|
0 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
AEs leading to treatment discontinuation
|
4 Participants
|
|
Safety and Tolerability of Ligelizumab 120 mg q4w Treatment for 12 Months
SAEs leading to treatment discontinuation
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
Mean change from baseline in UAS7 score over time is assessed as absolute change from baseline of UAS7 by visit up to end of study. The Urticaria Activity Score (UAS) is the sum of Hive Severity Score (HSS) and Itch Severiry Score (ISS). The HSS has a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement. The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement. The UAS7 is the sum of the HSS7 score and the ISS7 score, and has a possible range in score of 0-42. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
UAS7 Change From Baseline Over Time
Week 64
|
-15.87 Scores on a scale
Standard Deviation 11.829
|
|
UAS7 Change From Baseline Over Time
Week 12
|
-18.35 Scores on a scale
Standard Deviation 10.858
|
|
UAS7 Change From Baseline Over Time
Week 24
|
-20.64 Scores on a scale
Standard Deviation 11.082
|
|
UAS7 Change From Baseline Over Time
Week 52
|
-22.92 Scores on a scale
Standard Deviation 11.631
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
The HSS has a scale of 0 (none) to 3 (\> 12 hives/12 hours): 0 (None) 1. (1-6 hives/12 hours) 2. (7-12 hives/12 hours) 3. (\> 12 hives/12 hours) A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
HSS7 Change From Baseline Over Time
Week 12
|
-10.68 Scores on a scale
Standard Deviation 7.156
|
|
HSS7 Change From Baseline Over Time
Week 24
|
-11.93 Scores on a scale
Standard Deviation 6.815
|
|
HSS7 Change From Baseline Over Time
Week 52
|
-13.33 Scores on a scale
Standard Deviation 6.993
|
|
HSS7 Change From Baseline Over Time
Week 64
|
-9.29 Scores on a scale
Standard Deviation 7.136
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
The ISS has a scale of 0 (none) to 3 (severe): 0 None 1. Mild (minimal awareness, easily tolerated) 2. Moderate (definite awareness, bothersome but tolerable) 3. Severe (difficult to tolerate) The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. So the score range of ISS7 is 0-21; and a negative change from baseline indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
ISS7 Change From Baseline Over Time
Week 12
|
-7.68 Scores on a scale
Standard Deviation 4.376
|
|
ISS7 Change From Baseline Over Time
Week 24
|
-8.72 Scores on a scale
Standard Deviation 5.054
|
|
ISS7 Change From Baseline Over Time
Week 52
|
-9.59 Scores on a scale
Standard Deviation 5.434
|
|
ISS7 Change From Baseline Over Time
Week 64
|
-6.58 Scores on a scale
Standard Deviation 5.473
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
Assessed as the proportion of subjects achieving UAS7 = 0 over time. The UAS7 has a possible range in score of 0-42, and its complete response (complete urticaria control) was defined as UAS7 = 0
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Week 64
|
11 Participants
|
|
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Week 12
|
14 Participants
|
|
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Week 24
|
26 Participants
|
|
Percentage of Participants Who Achieved the Complete UAS7 = 0 Response Over Time
Week 52
|
28 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
The proportion of subjects achieving HSS7 = 0 (complete absence of hives) over time The HSS has a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days. So the range is 0-21; and negative change = improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
Week 12
|
17 Participants
|
|
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
Week 24
|
31 Participants
|
|
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
Week 52
|
33 Participants
|
|
Percentage of Participants Who Achieved the Complete HSS7 = 0 Response Over Time
Week 64
|
13 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
The ISS also has a scale of 0 (none) to 3 (severe/difficult to tolerate). A weekly score (ISS7) is derived by adding up the average daily scores of the preceding 7 days. Score range is 0-21; and a negative change from baseline indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
Week 24
|
27 Participants
|
|
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
Week 52
|
30 Participants
|
|
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
Week 64
|
12 Participants
|
|
Percentage of Participants Who Achieved the Complete ISS7 = 0 Response Over Time
Week 12
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 52 and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
Assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30: 0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life A negative change indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Week 12
|
-6.66 Scores on a scale
Standard Deviation 4.870
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Week 24
|
-6.39 Scores on a scale
Standard Deviation 6.127
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Week 52
|
-6.69 Scores on a scale
Standard Deviation 5.858
|
|
Change From Baseline in the Dermatology Life Quality Index (DLQI)
Week 64
|
-5.78 Scores on a scale
Standard Deviation 5.474
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 52, and 64Population: Safety Set: The number analyzed per row is the number of subjects from the SAF who had a valid assessment for both baseline and the corresponding post baseline time point.
Percentage of participants who achieved DLQI = 0/1 by visit up to end of study, assessed by absolute change from baseline of DLQI up to end of study. Score range is from 0-30: 0-1 No effect on patients life 2-5 Small effect on patients life 6-10 Moderate effect on patients life 11-20 Very large effect on patients life 21-30 Extremely large effect on patients life A negative change indicates improvement.
Outcome measures
| Measure |
Ligelizumab 120 mg Per 1 mL qw4
n=66 Participants
Subjects received one subcutaneous injection every 4 weeks at 13 visits from baseline to Week 48 during the treatment period. Last treatment was at week 48; and follow up visits were until week 64.
|
|---|---|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Week 12
|
37 Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Week 24
|
40 Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Week 52
|
44 Participants
|
|
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) = 0/1 by Visit up to End of Study
Week 64
|
30 Participants
|
Adverse Events
QGE031 120mg
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
QGE031 120mg
n=66 participants at risk
Ligelizumab 120 mg per 1 mL qw4
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Gastrointestinal disorders
Dental caries
|
6.1%
4/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
General disorders
Injection site erythema
|
4.5%
3/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
General disorders
Injection site pain
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
General disorders
Injection site reaction
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
General disorders
Malaise
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
General disorders
Pyrexia
|
9.1%
6/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Cystitis
|
4.5%
3/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Folliculitis
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Influenza
|
4.5%
3/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
8/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Infections and infestations
Oral herpes
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
5/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Nervous system disorders
Headache
|
6.1%
4/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Nervous system disorders
Hypoaesthesia
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.5%
3/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.6%
5/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
13.6%
9/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
3.0%
2/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.1%
4/66 • Adverse Events (AEs) and Serious Adverse Events were collected after signature of the informed consent form until the end of study at 64 weeks.
An AE is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER