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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
382
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
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
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
HSS7=0 Response: at Week 20 Measured Over 7 Days
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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
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
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
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
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
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
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
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
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
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