Chronic Spontaneous Urticaria
Conditions
Keywords
QGE031, ligelizumab, omalizumab, chronic, spontaneous, urticaria, adults, CSU
Brief summary
This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of chronic spontaneous urticaria for at least 6 months * Diagnosis of chronic spontaneous urticaria refractory to standard of care at time of randomization
Exclusion criteria
* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria * Evidence of parasitic infection * Any other skin disease with chronic itching * Previous treatment with omalizumab or QGE031 * Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine * History of anaphylaxis * History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study * History of hypersensitivity to any of the study drugs or its components of similar chemical classes * Pregnant or nursing (lactating) women Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Hives Response (HSS7=0) | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | 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) |
| HSS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | 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) |
| Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | Week 20 | 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) |
| Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | Week 12 | 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) |
| Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | Week 20 | 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) |
| Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | Week 12 | 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) |
| Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | Week 20 | 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 Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | 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. |
| UAS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | 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. |
| Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | 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) |
| ISS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | 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) |
| Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | Week 12 | UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. |
Countries
Australia, Canada, Germany, Greece, Japan, Russia, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| QGE031 24 mg s.c. q4w ligelizumab 24 mg injection subcutaneous every 4 weeks | 43 |
| QGE031 72 mg s.c. q4w ligelizumab 72 mg injection subcutaneous every 4 weeks | 84 |
| QGE031 240 mg s.c. q4w ligelizumab 240 mg injection subcutaneous every 4 weeks | 85 |
| Omalizumab 300 mg s.c. q4w omalizumab 300 mg injection subcutaneous every 4 weeks | 85 |
| Placebo s.c. q4w placebo injection subcutaneous every 4 weeks | 43 |
| QGE031 120 mg s.c. s.d. ligelizumab 120 mg injection subcutaneous single dose | 42 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 2 | 1 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 | 1 | 2 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Non-compliance with study treatment | 0 | 1 | 2 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 3 | 0 | 1 |
| 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 | Withdrawal by Subject | 0 | 3 | 1 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | 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. | QGE031 24 mg s.c. q4w | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 0 Participants | 4 Participants | 2 Participants | 5 Participants | 4 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 85 Participants | 81 Participants | 41 Participants | 37 Participants | 39 Participants | 360 Participants |
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12.38 | 42.9 years STANDARD_DEVIATION 10.51 | 41.8 years STANDARD_DEVIATION 13.06 | 45.4 years STANDARD_DEVIATION 11.22 | 42.4 years STANDARD_DEVIATION 14.54 | 44.1 years STANDARD_DEVIATION 14.36 | 43.3 years STANDARD_DEVIATION 12.49 |
| Sex: Female, Male Female | 61 Participants | 67 Participants | 66 Participants | 31 Participants | 30 Participants | 31 Participants | 286 Participants |
| Sex: Female, Male Male | 23 Participants | 18 Participants | 19 Participants | 12 Participants | 12 Participants | 12 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 84 | 0 / 85 | 0 / 85 | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 24 / 43 | 45 / 84 | 46 / 85 | 44 / 85 | 30 / 43 | 28 / 42 |
| serious Total, serious adverse events | 3 / 43 | 2 / 84 | 2 / 85 | 3 / 85 | 4 / 43 | 4 / 42 |
Outcome results
Primary
Percentage of Participants With Complete Hives Response (HSS7=0)
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.
Time frame: Week 12
Population: Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Percentage of Participants With Complete Hives Response (HSS7=0) | 30.2 Percentage of participants |
| QGE031 72 mg s.c. q4w | Percentage of Participants With Complete Hives Response (HSS7=0) | 51.2 Percentage of participants |
| QGE031 240 mg s.c. q4w | Percentage of Participants With Complete Hives Response (HSS7=0) | 42.4 Percentage of participants |
| Omalizumab 300 mg s.c. q4w | Percentage of Participants With Complete Hives Response (HSS7=0) | 25.9 Percentage of participants |
| Placebo s.c. q4w | Percentage of Participants With Complete Hives Response (HSS7=0) | 0 Percentage of participants |
| QGE031 120 mg s.c. s.d. | Percentage of Participants With Complete Hives Response (HSS7=0) | 19.0 Percentage of participants |
p-value: <0.0560% CI: [27.5, 42.5]Regression, Logistic
Secondary
Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days
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)
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | -9.75 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | -15.50 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | -13.50 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | -11.00 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | -6.50 Score on a scale |
Secondary
Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days
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)
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | -9.00 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | -16.50 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | -14.00 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | -11.00 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | -7.50 Score on a scale |
Secondary
Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days
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)
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | -7.50 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | -9.50 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | -9.00 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | -8.00 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | -5.50 Score on a scale |
Secondary
Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days
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)
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | -7.00 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | -10.25 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | -10.00 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | -8.83 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | -5.00 Score on a scale |
Secondary
Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | -19.50 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | -26.50 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | -21.75 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | -19.00 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | -12.00 Score on a scale |
Secondary
Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days
UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | -16.00 Score on a scale |
| QGE031 72 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | -27.00 Score on a scale |
| QGE031 240 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | -22.92 Score on a scale |
| Omalizumab 300 mg s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | -18.50 Score on a scale |
| Placebo s.c. q4w | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | -13.00 Score on a scale |
Secondary
Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days
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)
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | 13 Particpants |
| QGE031 72 mg s.c. q4w | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | 43 Particpants |
| QGE031 240 mg s.c. q4w | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | 36 Particpants |
| Omalizumab 300 mg s.c. q4w | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | 22 Particpants |
| Placebo s.c. q4w | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | 0 Particpants |
Secondary
Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days
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)
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | 17 participants |
| QGE031 72 mg s.c. q4w | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | 40 participants |
| QGE031 240 mg s.c. q4w | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | 36 participants |
| Omalizumab 300 mg s.c. q4w | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | 25 participants |
| Placebo s.c. q4w | Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days | 2 participants |
Secondary
Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | 13 Participants |
| QGE031 72 mg s.c. q4w | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | 37 Participants |
| QGE031 240 mg s.c. q4w | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | 34 Participants |
| Omalizumab 300 mg s.c. q4w | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | 22 Participants |
| Placebo s.c. q4w | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | 0 Participants |
Secondary
HSS7=0 Response: at Week 20 Measured Over 7 Days
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)
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | HSS7=0 Response: at Week 20 Measured Over 7 Days | 11 Participants |
| QGE031 72 mg s.c. q4w | HSS7=0 Response: at Week 20 Measured Over 7 Days | 43 Participants |
| QGE031 240 mg s.c. q4w | HSS7=0 Response: at Week 20 Measured Over 7 Days | 38 Participants |
| Omalizumab 300 mg s.c. q4w | HSS7=0 Response: at Week 20 Measured Over 7 Days | 29 Participants |
| Placebo s.c. q4w | HSS7=0 Response: at Week 20 Measured Over 7 Days | 4 Participants |
Secondary
ISS7=0 Response: at Week 20 Measured Over 7 Days
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)
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | ISS7=0 Response: at Week 20 Measured Over 7 Days | 8 participants |
| QGE031 72 mg s.c. q4w | ISS7=0 Response: at Week 20 Measured Over 7 Days | 35 participants |
| QGE031 240 mg s.c. q4w | ISS7=0 Response: at Week 20 Measured Over 7 Days | 36 participants |
| Omalizumab 300 mg s.c. q4w | ISS7=0 Response: at Week 20 Measured Over 7 Days | 28 participants |
| Placebo s.c. q4w | ISS7=0 Response: at Week 20 Measured Over 7 Days | 3 participants |
Secondary
UAS7=0 Response: at Week 20 Measured Over 7 Days
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.
Time frame: Week 20
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| QGE031 24 mg s.c. q4w | UAS7=0 Response: at Week 20 Measured Over 7 Days | 8 participants |
| QGE031 72 mg s.c. q4w | UAS7=0 Response: at Week 20 Measured Over 7 Days | 33 participants |
| QGE031 240 mg s.c. q4w | UAS7=0 Response: at Week 20 Measured Over 7 Days | 34 participants |
| Omalizumab 300 mg s.c. q4w | UAS7=0 Response: at Week 20 Measured Over 7 Days | 26 participants |
| Placebo s.c. q4w | UAS7=0 Response: at Week 20 Measured Over 7 Days | 2 participants |