Trial · NCT03580369
A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
NCT03580369, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2022-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Trials, record NCT03580369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03580369
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
- NCT number
- NCT03580369
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,072 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Ligelizumab, Omalizumab, Placebo
- First posted
- 2018-07-09
- Last updated
- 2023-07-24
- Other registries' IDs
- eudract:2018-000839-28
- Results first posted
- 2022-12-30
- Limitations and caveats
The difference of 4 subjects between RAN (1034) vs FAS (1030) is due to mis-randomization of 4 subjects. These subjects did not receive Ligelizumab and hence rightfully not included in FAS (though included in RAN).
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Baseline, Week 12 | The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. 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). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of 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). Negative change from baseline indicates improvement |
| Primary | Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Baseline, Week 12 | The Urticaria Activity Score (UAS) is sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is sum of the HSS7 and the ISS7 scores. Possible range of weekly UAS7 score is 0 to 42. Complete UAS7 response is UAS7 = 0. Hives Severity Score (HSS) scale is 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. 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). Itch Severity Score (ISS) scale is 0 to 3. Score (ISS7) is derived by adding up average daily scores of 7 days preceding visit. Possible range of 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). Negative change from baseline indicates improvement |
| Secondary | Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Week 12 | The Urticaria Activity Score (UAS) is the sum of the Hive Severity Score (HSS) and the Itch Severity Score (ISS). UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42. Complete UAS7 response is defined as UAS7 = 0. No Statistical analysis was planned for adolescent group. |
| Secondary | Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS) | Baseline, Week 12 | Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at 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) Negative change from baseline indicates improvement. |
| Secondary | Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS) | Baseline, Week 12 | Improvement of severity of itch assessed as absolute change from baseline in ISS7 score at 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) Negative change from baseline indicates improvement.. No Statistical Analysis was planned for adolescent population. |
| Secondary | Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Baseline, Week 12 | Assessed as percentage of subjects achieving DLQI = 0-1, meaning, no impact on subjects quality of life at Week 12 The Dermatology life Quality Index (DLQI) score range is 0 to 30, with 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). No statistical anaylsis was planned for adolescent group. |
| Secondary | Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS) | Baseline, Week 12 | Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. |
| Secondary | Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS) | Baseline, Week 12 | Cumulative number of weeks that subjects achieve AAS7 = 0 responses between baseline and Week 12 Angioedema Activity Score (AAS7) is a measure of the frequency and intensity of angioedema episodes. The total possible range of scores over 7 days is 0-15 (mean day sum score) where higher scores indicate increased angioedema activity. No Statistical Analysis was planned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Baseline, Week 12 | Full analysis set (FAS) included all randomized Adult subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated. | Score | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Baseline, Week 12 | Full analysis set (FAS) included all randomized adolescent subjects who received at least one dose of study drug. Subjects were analyzed according to the treatment to which they were assigned at randomization. FAS was used for all efficacy variables, unless otherwise stated. | Score | MEAN |
| SECONDARY | Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Week 12 | FAS: Adults + Adolescents (observed data) = Total | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS) | Baseline, Week 12 | FAS: Adults | score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS) | Baseline, Week 12 | FAS: Adolescents | score | MEAN |
| SECONDARY | Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Baseline, Week 12 | FAS: Adults + Adolescents (observed) = Total | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS) | Baseline, Week 12 | FAS: Adults | Weeks | LEAST_SQUARES_MEAN |
| SECONDARY | Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS) | Baseline, Week 12 | FAS: Adolescents | Weeks | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Ligelizumab 72 mg | -19.368 | Standard Error 0.668 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Ligelizumab 120 mg | -19.330 | Standard Error 0.660 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Omalizumab 300 mg | -20.040 | Standard Error 0.663 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Placebo | -11.366 | Standard Error 1.129 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Ligelizumab 72 mg | -17.39 | Standard Deviation 13.070 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Ligelizumab 120 mg | -14.64 | Standard Deviation 14.662 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Omalizumab 300 mg | -13.84 | Standard Deviation 15.343 | Score | |
| Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | Placebo | -12.75 | Standard Deviation 18.738 | Score | |
| Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 72 mg | Adults | 102 | Participants | |
| Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 120 mg | Adults | 104 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ligelizumab 72 mg - Adults | 307 | |
| Overall Study | STARTED | Ligelizumab 72 mg - Adolescents | 10 | |
| Overall Study | STARTED | Ligelizumab 120 mg - Adults | 312 | |
| Overall Study | STARTED | Ligelizumab 120 mg - Adolescents | 12 | |
| Overall Study | STARTED | Omalizumab 300 mg - Adults | 309 | |
| Overall Study | STARTED | Omalizumab 300 mg - Adolescents | 13 | |
| Overall Study | STARTED | Placebo - Ligelizumab 120mg - Adults | 106 | |
| Overall Study | STARTED | Placebo - Ligelizumab 120mg - Adolesecents | 3 | |
| Overall Study | COMPLETED | Ligelizumab 72 mg - Adults | 263 | |
| Overall Study | COMPLETED | Ligelizumab 72 mg - Adolescents | 10 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events600
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 | Abdominal pain | Gastrointestinal disorders | QGE031 72mg | 1 | 316 | |
| other | Abdominal pain | Gastrointestinal disorders | QGE031 120mg | 6 | 324 | |
| other | Abdominal pain | Gastrointestinal disorders | Omalizumab 300mg | 9 | 319 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Only | 0 | 109 | |
| other | Abdominal pain | Gastrointestinal disorders | Transitioned to QGE031 120mg | 0 | 102 | |
| other | Abdominal pain upper | Gastrointestinal disorders | QGE031 72mg | 7 | 316 | |
| other | Abdominal pain upper | Gastrointestinal disorders | QGE031 120mg | 5 | 324 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Omalizumab 300mg | 8 | 319 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo Only | 2 | 109 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Transitioned to QGE031 120mg | 2 | 102 |
1 to 10 of 600Source ClinicalTrials.gov
See all 600 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QGE031 72mg | 0 | 316 |
| Total, all-cause mortality | QGE031 120mg | 0 | 324 |
| Total, all-cause mortality | Omalizumab 300mg | 0 | 319 |
| Total, all-cause mortality | Placebo Only | 0 | 109 |
| Total, all-cause mortality | Transitioned to QGE031 120mg | 0 | 102 |
| Total, other adverse events | QGE031 72mg | 178 | 316 |
| Total, other adverse events | QGE031 120mg | 182 | 324 |
| Total, other adverse events | Omalizumab 300mg | 206 | 319 |
| Total, other adverse events | Placebo Only | 38 | 109 |
| Total, other adverse events | Transitioned to QGE031 120mg | 43 | 102 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38008109 | DERIVED |
Source PubMed
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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