Trial Outcomes & Findings for Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU (NCT NCT02477332)
NCT ID: NCT02477332
Last Updated: 2021-01-05
Results Overview
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
COMPLETED
PHASE2
382 participants
Week 12
2021-01-05
Participant Flow
574 subjects screened; 382 subjects randomized; 338 (88.5%) subjects completed treatment epoch; 349 (91.4%) subjects entered follow-up phase and 320 (83.8%) completed the follow-up epoch
Participant milestones
| Measure |
QGE031 24 mg s.c. q4w
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 72 mg s.c. q4w
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo s.c. q4w
placebo injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
43
|
84
|
85
|
85
|
43
|
42
|
|
Overall Study
COMPLETED
|
40
|
77
|
73
|
72
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
12
|
13
|
4
|
5
|
Reasons for withdrawal
| Measure |
QGE031 24 mg s.c. q4w
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 72 mg s.c. q4w
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo s.c. q4w
placebo injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
1
|
2
|
1
|
1
|
|
Overall Study
Non-compliance with study treatment
|
0
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
3
|
3
|
1
|
1
|
|
Overall Study
Technical problems
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
2
|
1
|
0
|
Baseline Characteristics
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Baseline characteristics by cohort
| Measure |
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo s.c. q4w
n=43 Participants
placebo injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
n=42 Participants
ligelizumab 120 mg injection subcutaneous single dose
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
360 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 14.36 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12.38 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 13.06 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 11.22 • n=21 Participants
|
42.4 years
STANDARD_DEVIATION 14.54 • n=10 Participants
|
43.3 years
STANDARD_DEVIATION 12.49 • n=115 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
286 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
96 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.
The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks). Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours) To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg.
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
n=42 Participants
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Complete Hives Response (HSS7=0)
|
51.2 Percentage of participants
Interval 40.0 to 62.3
|
42.4 Percentage of participants
Interval 31.7 to 53.6
|
25.9 Percentage of participants
Interval 17.0 to 36.5
|
0 Percentage of participants
Interval 0.0 to 8.2
|
30.2 Percentage of participants
Interval 17.2 to 46.1
|
19.0 Percentage of participants
Interval 8.6 to 34.1
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete hives response defined as HSS7 = 0. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
|
43 Particpants
|
36 Particpants
|
22 Particpants
|
0 Particpants
|
13 Particpants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=81 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=78 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=77 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=41 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=40 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
|
-15.50 Score on a scale
Interval -20.0 to -6.0
|
-13.50 Score on a scale
Interval -19.0 to -9.0
|
-11.00 Score on a scale
Interval -16.5 to -4.5
|
-6.50 Score on a scale
Interval -13.0 to -2.33
|
-9.75 Score on a scale
Interval -15.75 to -2.5
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete hives response defined as HSS7 = 0. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
HSS7=0 Response: at Week 20 Measured Over 7 Days
|
43 Participants
|
38 Participants
|
29 Participants
|
4 Participants
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Hives Severity Score scale: 0 - None 1. \- Mild (1-6 hives/12 hours) 2. \- Moderate (7-12 hives/12 hours) 3. \- Severe (\>12 hives/12 hours)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=78 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=74 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=73 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=40 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=39 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
|
-16.50 Score on a scale
Interval -20.5 to -6.83
|
-14.00 Score on a scale
Interval -19.5 to -9.0
|
-11.00 Score on a scale
Interval -16.0 to -4.25
|
-7.50 Score on a scale
Interval -13.5 to -2.25
|
-9.00 Score on a scale
Interval -12.5 to -3.5
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=81 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=78 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=77 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=41 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=40 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
|
-9.50 Score on a scale
Interval -14.5 to -6.0
|
-9.00 Score on a scale
Interval -14.0 to -4.5
|
-8.00 Score on a scale
Interval -11.5 to -4.5
|
-5.50 Score on a scale
Interval -8.5 to -2.5
|
-7.50 Score on a scale
Interval -12.75 to -3.5
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Itch Severity Score scale: 0 - None 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=78 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=74 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=73 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=40 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=39 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
|
-10.25 Score on a scale
Interval -14.0 to -6.5
|
-10.00 Score on a scale
Interval -14.0 to -5.5
|
-8.83 Score on a scale
Interval -11.5 to -3.5
|
-5.00 Score on a scale
Interval -9.5 to -2.25
|
-7.00 Score on a scale
Interval -11.0 to -2.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=81 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=78 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=77 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=41 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=40 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
|
-26.50 Score on a scale
Interval -33.0 to -12.0
|
-21.75 Score on a scale
Interval -32.5 to -14.0
|
-19.00 Score on a scale
Interval -29.0 to -8.5
|
-12.00 Score on a scale
Interval -21.0 to -6.0
|
-19.50 Score on a scale
Interval -26.75 to -6.25
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=78 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=74 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=73 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=40 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=39 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
|
-27.00 Score on a scale
Interval -33.0 to -15.0
|
-22.92 Score on a scale
Interval -32.5 to -13.5
|
-18.50 Score on a scale
Interval -28.5 to -11.0
|
-13.00 Score on a scale
Interval -21.0 to -5.5
|
-16.00 Score on a scale
Interval -23.0 to -7.0
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete urticaria activity response is defined as UAS7 = 0.
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
|
37 Participants
|
34 Participants
|
22 Participants
|
0 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete urticaria activity response is defined as UAS7 = 0.
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
UAS7=0 Response: at Week 20 Measured Over 7 Days
|
33 participants
|
34 participants
|
26 participants
|
2 participants
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete itch response defined as ISS7 = 0. Itch Severity Score scale: 0 - None 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
|
40 participants
|
36 participants
|
25 participants
|
2 participants
|
17 participants
|
—
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 \& 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.
Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21. Complete itch response defined as ISS7 = 0. Itch Severity Score scale: 0 - None 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (definite awareness, bothersome but tolerable) 3. \- Severe (difficult to tolerate)
Outcome measures
| Measure |
QGE031 72 mg s.c. q4w
n=84 Participants
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 Participants
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 Participants
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo
n=43 Participants
placebo injection subcutaneous every 4 week
|
QGE031 24 mg s.c. q4w
n=43 Participants
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
ISS7=0 Response: at Week 20 Measured Over 7 Days
|
35 participants
|
36 participants
|
28 participants
|
3 participants
|
8 participants
|
—
|
Adverse Events
QGE031 24 mg s.c. q4w
QGE031 72 mg s.c. q4w
QGE031 240 mg s.c. q4w
Omalizumab 300 mg s.c. q4w
Placebo s.c. q4w
QGE031 120 mg s.c. s.d.
Serious adverse events
| Measure |
QGE031 24 mg s.c. q4w
n=43 participants at risk
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 72 mg s.c. q4w
n=84 participants at risk
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 participants at risk
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 participants at risk
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo s.c. q4w
n=43 participants at risk
placebo injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
n=42 participants at risk
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Diverticular perforation
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Hepatobiliary disorders
Hepatitis acute
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
1.2%
1/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
1.2%
1/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
Other adverse events
| Measure |
QGE031 24 mg s.c. q4w
n=43 participants at risk
ligelizumab 24 mg injection subcutaneous every 4 weeks
|
QGE031 72 mg s.c. q4w
n=84 participants at risk
ligelizumab 72 mg injection subcutaneous every 4 weeks
|
QGE031 240 mg s.c. q4w
n=85 participants at risk
ligelizumab 240 mg injection subcutaneous every 4 weeks
|
Omalizumab 300 mg s.c. q4w
n=85 participants at risk
omalizumab 300 mg injection subcutaneous every 4 weeks
|
Placebo s.c. q4w
n=43 participants at risk
placebo injection subcutaneous every 4 weeks
|
QGE031 120 mg s.c. s.d.
n=42 participants at risk
ligelizumab 120 mg injection subcutaneous single dose
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
10.7%
9/84 • Through study completion, an average of 44 weeks.
|
3.5%
3/85 • Through study completion, an average of 44 weeks.
|
4.7%
4/85 • Through study completion, an average of 44 weeks.
|
11.6%
5/43 • Through study completion, an average of 44 weeks.
|
16.7%
7/42 • Through study completion, an average of 44 weeks.
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
6.0%
5/84 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
7.0%
3/43 • Through study completion, an average of 44 weeks.
|
7.1%
3/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.7%
2/43 • Through study completion, an average of 44 weeks.
|
4.8%
4/84 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
7.1%
6/85 • Through study completion, an average of 44 weeks.
|
4.7%
2/43 • Through study completion, an average of 44 weeks.
|
4.8%
2/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
7.1%
3/42 • Through study completion, an average of 44 weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
1.2%
1/84 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
4.7%
2/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
General disorders
Injection site erythema
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
2/84 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
General disorders
Injection site reaction
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
3.6%
3/84 • Through study completion, an average of 44 weeks.
|
7.1%
6/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
1.2%
1/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Influenza
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
4.8%
4/84 • Through study completion, an average of 44 weeks.
|
4.7%
4/85 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.3%
7/43 • Through study completion, an average of 44 weeks.
|
8.3%
7/84 • Through study completion, an average of 44 weeks.
|
11.8%
10/85 • Through study completion, an average of 44 weeks.
|
11.8%
10/85 • Through study completion, an average of 44 weeks.
|
14.0%
6/43 • Through study completion, an average of 44 weeks.
|
21.4%
9/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
6.0%
5/84 • Through study completion, an average of 44 weeks.
|
4.7%
4/85 • Through study completion, an average of 44 weeks.
|
5.9%
5/85 • Through study completion, an average of 44 weeks.
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
4.8%
2/42 • Through study completion, an average of 44 weeks.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
16.3%
7/43 • Through study completion, an average of 44 weeks.
|
15.5%
13/84 • Through study completion, an average of 44 weeks.
|
20.0%
17/85 • Through study completion, an average of 44 weeks.
|
20.0%
17/85 • Through study completion, an average of 44 weeks.
|
30.2%
13/43 • Through study completion, an average of 44 weeks.
|
23.8%
10/42 • Through study completion, an average of 44 weeks.
|
|
Investigations
Blood creatinine increased
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
3.6%
3/84 • Through study completion, an average of 44 weeks.
|
3.5%
3/85 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
9.3%
4/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
7.1%
6/84 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • Through study completion, an average of 44 weeks.
|
1.2%
1/84 • Through study completion, an average of 44 weeks.
|
0.00%
0/85 • Through study completion, an average of 44 weeks.
|
1.2%
1/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
7.1%
3/42 • Through study completion, an average of 44 weeks.
|
|
Nervous system disorders
Dizziness
|
4.7%
2/43 • Through study completion, an average of 44 weeks.
|
6.0%
5/84 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
9.3%
4/43 • Through study completion, an average of 44 weeks.
|
0.00%
0/42 • Through study completion, an average of 44 weeks.
|
|
Nervous system disorders
Headache
|
16.3%
7/43 • Through study completion, an average of 44 weeks.
|
10.7%
9/84 • Through study completion, an average of 44 weeks.
|
8.2%
7/85 • Through study completion, an average of 44 weeks.
|
14.1%
12/85 • Through study completion, an average of 44 weeks.
|
16.3%
7/43 • Through study completion, an average of 44 weeks.
|
2.4%
1/42 • Through study completion, an average of 44 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
6.0%
5/84 • Through study completion, an average of 44 weeks.
|
4.7%
4/85 • Through study completion, an average of 44 weeks.
|
2.4%
2/85 • Through study completion, an average of 44 weeks.
|
2.3%
1/43 • Through study completion, an average of 44 weeks.
|
7.1%
3/42 • Through study completion, an average of 44 weeks.
|
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