Trial · NCT03580356
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
NCT03580356, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Trials, record NCT03580356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03580356
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
- NCT number
- NCT03580356
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,078 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Ligelizumab, Omalizumab, Placebo
- First posted
- 2018-07-09
- Last updated
- 2025-01-07
- Other registries' IDs
- eudract:2018-000840-24
- Results first posted
- 2024-03-25
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 Percentage 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. Data is presented as percentage of patients with a UAS7=0 score. 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 Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Week 12 | Assessed as percentage of subjects achieving DLQI = 0-1, which means 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). Data is presented as percentage of patients with a DLQI=0 score. No statistical analysis 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 |
|---|---|---|---|---|---|
| SECONDARY | Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Week 12 | FAS: Adults + Adolescents = Total | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Scores on a scale | 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. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS) | Baseline, Week 12 | FAS: Adults | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS) | Baseline, Week 12 | FAS: Adolescents | scores on a scale | MEAN |
| SECONDARY | Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Week 12 | FAS: Adults + Adolescents = 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 |
|---|---|---|---|---|---|
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 72 mg | Adults | 88 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 120 mg | Adults | 103 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Omalizumab 300 mg | Adults | 94 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Placebo | Adults | 4 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 72 mg | Adolescents | 4 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Ligelizumab 120 mg | Adolescents | 8 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Omalizumab 300 mg | Adolescents | 5 | Participants | |
| Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents) | Placebo | Adolescents | 0 | Participants | |
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Ligelizumab 72 mg | -19.218 | Standard Error 0.651 | Scores on a scale | |
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | Ligelizumab 120 mg | -20.312 | Standard Error 0.654 | Scores on a scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Ligelizumab 72 mg - Adults | 307 | |
| Treatment Period | STARTED | Ligelizumab 72 mg - Adolescents | 16 | |
| Treatment Period | STARTED | Ligelizumab 120 mg - Adults | 304 | |
| Treatment Period | STARTED | Ligelizumab 120 mg - Adolescents | 19 | |
| Treatment Period | STARTED | Omalizumab 300 mg - Adults | 309 | |
| Treatment Period | STARTED | Omalizumab 300 mg - Adolescents | 14 | |
| Treatment Period | STARTED | Placebo - Ligelizumab 120mg - Adults | 103 | |
| Treatment Period | STARTED | Placebo - Ligelizumab 120mg - Adolescents | 6 | |
| Treatment Period | Randomized Set (RAN) | Ligelizumab 72 mg - Adults | 307 | |
| Treatment Period | Randomized Set (RAN) | Ligelizumab 72 mg - Adolescents | 16 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events750
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 | Anaemia | Blood and lymphatic system disorders | Ligelizumab 72mg (Adults) | 3 | 304 | |
| other | Anaemia | Blood and lymphatic system disorders | Ligelizumab 72mg (Adolescents) | 1 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Ligelizumab 72mg (Adults+Adolescents) | 4 | 320 | |
| other | Anaemia | Blood and lymphatic system disorders | Ligelizumab 120 mg (Adults) | 5 | 306 | |
| other | Anaemia | Blood and lymphatic system disorders | Ligelizumab 120 mg (Adolescents) | 0 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Ligelizumab 120 mg (Adults+Adolescents) | 5 | 325 | |
| other | Anaemia | Blood and lymphatic system disorders | Omalizumab 300mg (Adults) | 8 | 307 | |
| other | Anaemia | Blood and lymphatic system disorders | Omalizumab 300mg (Adolescents) | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Omalizumab 300mg (Adults+Adolescents) | 8 | 321 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Only (Adults) | 1 | 103 |
1 to 10 of 750Source ClinicalTrials.gov
See all 750 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ligelizumab 72mg (Adults) | 0 | 304 |
| Total, all-cause mortality | Ligelizumab 72mg (Adolescents) | 0 | 16 |
| Total, all-cause mortality | Ligelizumab 72mg (Adults+Adolescents) | 0 | 320 |
| Total, all-cause mortality | Ligelizumab 120 mg (Adults) | 1 | 306 |
| Total, all-cause mortality | Ligelizumab 120 mg (Adolescents) | 0 | 19 |
| Total, all-cause mortality | Ligelizumab 120 mg (Adults+Adolescents) | 1 | 325 |
| Total, all-cause mortality | Omalizumab 300mg (Adults) | 0 | 307 |
| Total, all-cause mortality | Omalizumab 300mg (Adolescents) | 0 | 14 |
| Total, all-cause mortality | Omalizumab 300mg (Adults+Adolescents) | 0 | 321 |
| Total, all-cause mortality | Placebo Only (Adults) | 0 | 103 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 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.
GET https://conductscience.org/api/trials/v1/NCT03580356
GET https://conductscience.org/api/trials/v1/NCT03580356/results?page=2