Trial · NCT02477332
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
NCT02477332, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2018-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU. Trials, record NCT02477332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477332
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
- NCT number
- NCT02477332
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 382 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- QGE031, Omalizumab, Placebo
- First posted
- 2015-06-22
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2014-005559-16
- Results first posted
- 2018-09-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Hives Response (HSS7=0) | Week 12 | Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. | Percentage of participants | NUMBER |
| SECONDARY | Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | 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. | Particpants | NUMBER |
| SECONDARY | Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days | Week 12 | 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. | Score on a scale | MEDIAN |
| SECONDARY | HSS7=0 Response: at Week 20 Measured Over 7 Days | Week 20 | 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. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days | Week 20 | 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. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days | Week 12 | 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. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days | Week 20 | 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. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days | Week 12 | 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. | Score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days | Week 20 | 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. | Score on a scale | MEDIAN |
| SECONDARY | Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days | Week 12 | 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. | Participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Hives Response (HSS7=0) | QGE031 24 mg s.c. q4w | 30.2 | 95% Confidence Interval 17.2 to 46.1 | Percentage of participants | |
| Percentage of Participants With Complete Hives Response (HSS7=0) | QGE031 72 mg s.c. q4w | 51.2 | 95% Confidence Interval 40.0 to 62.3 | Percentage of participants | |
| Percentage of Participants With Complete Hives Response (HSS7=0) | QGE031 240 mg s.c. q4w | 42.4 | 95% Confidence Interval 31.7 to 53.6 | Percentage of participants | |
| Percentage of Participants With Complete Hives Response (HSS7=0) | Omalizumab 300 mg s.c. q4w | 25.9 | 95% Confidence Interval 17.0 to 36.5 | Percentage of participants | |
| Percentage of Participants With Complete Hives Response (HSS7=0) | Placebo s.c. q4w | 0 | 95% Confidence Interval 0.0 to 8.2 | Percentage of participants | |
| Percentage of Participants With Complete Hives Response (HSS7=0) | QGE031 120 mg s.c. s.d. | 19.0 | 95% Confidence Interval 8.6 to 34.1 | Percentage of participants | |
| Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | QGE031 24 mg s.c. q4w | 13 | Particpants | ||
| Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | QGE031 72 mg s.c. q4w | 43 | Particpants | ||
| Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | QGE031 240 mg s.c. q4w | 36 | Particpants | ||
| Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days | Omalizumab 300 mg s.c. q4w | 22 | Particpants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QGE031 24 mg s.c. q4w | 43 | |
| Overall Study | STARTED | QGE031 72 mg s.c. q4w | 84 | |
| Overall Study | STARTED | QGE031 240 mg s.c. q4w | 85 | |
| Overall Study | STARTED | Omalizumab 300 mg s.c. q4w | 85 | |
| Overall Study | STARTED | Placebo s.c. q4w | 43 | |
| Overall Study | STARTED | QGE031 120 mg s.c. s.d. | 42 | |
| Overall Study | COMPLETED | QGE031 24 mg s.c. q4w | 40 | |
| Overall Study | COMPLETED | QGE031 72 mg s.c. q4w | 77 | |
| Overall Study | COMPLETED | QGE031 240 mg s.c. q4w | 73 | |
| Overall Study | COMPLETED | Omalizumab 300 mg s.c. q4w | 72 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events270
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | QGE031 24 mg s.c. q4w | 2 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | QGE031 72 mg s.c. q4w | 4 | 84 | |
| other | Diarrhoea | Gastrointestinal disorders | QGE031 240 mg s.c. q4w | 5 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Omalizumab 300 mg s.c. q4w | 6 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo s.c. q4w | 2 | 43 | |
| other | Diarrhoea | Gastrointestinal disorders | QGE031 120 mg s.c. s.d. | 2 | 42 | |
| other | Gastritis | Gastrointestinal disorders | QGE031 24 mg s.c. q4w | 0 | 43 | |
| other | Gastritis | Gastrointestinal disorders | QGE031 72 mg s.c. q4w | 0 | 84 | |
| other | Gastritis | Gastrointestinal disorders | QGE031 240 mg s.c. q4w | 0 | 85 | |
| other | Gastritis | Gastrointestinal disorders | Omalizumab 300 mg s.c. q4w | 0 | 85 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QGE031 24 mg s.c. q4w | 0 | 43 |
| Total, all-cause mortality | QGE031 72 mg s.c. q4w | 0 | 84 |
| Total, all-cause mortality | QGE031 240 mg s.c. q4w | 0 | 85 |
| Total, all-cause mortality | Omalizumab 300 mg s.c. q4w | 0 | 85 |
| Total, all-cause mortality | Placebo s.c. q4w | 0 | 43 |
| Total, all-cause mortality | QGE031 120 mg s.c. s.d. | 0 | 42 |
| Total, other adverse events | QGE031 24 mg s.c. q4w | 24 | 43 |
| Total, other adverse events | QGE031 72 mg s.c. q4w | 45 | 84 |
| Total, other adverse events | QGE031 240 mg s.c. q4w | 46 | 85 |
| Total, other adverse events | Omalizumab 300 mg s.c. q4w | 44 | 85 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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