Trial · NCT02477332
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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) |
| Secondary | 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) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02477332/registered