A Phase 3 interventional study of Ligelizumab and Omalizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Completed at 183 sites in 27 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study was to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remained symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,079 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines.
This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.
This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's enrollment of 1,078 is above the median of 61 across 174 interventional studies indexed under Urticaria.
Browse Urticaria studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Biological: Omalizumab
Placebo-ligelizumab arm: 2 injections of 1.0mL of ligelizumab placebo from Week 0 through Week 20; 1 injection of 1.0mL of ligelizumab 120 mg + 1 injection of 1.0 mL ligelizumab placebo from Week 24 through Week 48
Other: Placebo
Liquid in vial
Lyophilized powder for solution in vial
Liquid in vial
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
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
Time frame: Baseline, Week 12
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
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
Time frame: Baseline, Week 12
Number and Percentage of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
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.
Time frame: Week 12
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
Time frame: Baseline, Week 12
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
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.
Time frame: Baseline, Week 12
Number and Percentage of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
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.
Time frame: Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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.
Time frame: Baseline, Week 12
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
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.
Time frame: Baseline, Week 12
1,078 participants enrolled in 27 countries at 185 sites.
| Milestone | Ligelizumab 72 mg - Adults | Ligelizumab 72 mg - Adolescents | Ligelizumab 120 mg - Adults | Ligelizumab 120 mg - Adolescents | Omalizumab 300 mg - Adults | Omalizumab 300 mg - Adolescents | Placebo - Ligelizumab 120mg - Adults | Placebo - Ligelizumab 120mg - Adolescents |
|---|---|---|---|---|---|---|---|---|
| Started | 307 | 16 | 304 | 19 | 309 | 14 | 103 | 6 |
| Randomized set (ran) | 307 | 16 | 304 | 19 | 309 | 14 | 103 | 6 |
| Safety set (saf) | 304 | 16 | 306 | 19 | 307 | 14 | 103 | 6 |
| Full analysis set (fas) | 307 | 16 | 303 | 19 | 307 | 14 | 103 | 6 |
| Completed | 269 | 15 | 259 | 17 | 263 | 13 | 82 | 6 |
| Not completed | 38 | 1 | 45 | 2 | 46 | 1 | 21 | 0 |
| Withdrew: Withdrawal by subject | 13 | 0 | 13 | 1 | 17 | 0 | 5 | 0 |
| Withdrew: Adverse event | 10 | 0 | 13 | 0 | 5 | 0 | 8 | 0 |
| Withdrew: Protocol violation | 5 | 0 | 6 | 1 | 9 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 6 | 0 | 2 | 0 | 3 | 0 | 3 | 0 |
| Withdrew: Pregnancy | 1 | 0 | 7 | 0 | 2 | 0 | 1 | 0 |
| Withdrew: Physician decision | 2 | 0 | 1 | 0 | 4 | 0 | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 0 | 3 | 0 | 1 | 0 |
| Withdrew: Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Technical problems | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Misrandomized, no treatment | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
| Milestone | Ligelizumab 72 mg - Adults | Ligelizumab 72 mg - Adolescents | Ligelizumab 120 mg - Adults | Ligelizumab 120 mg - Adolescents | Omalizumab 300 mg - Adults | Omalizumab 300 mg - Adolescents | Placebo - Ligelizumab 120mg - Adults | Placebo - Ligelizumab 120mg - Adolescents |
|---|---|---|---|---|---|---|---|---|
| Started | 272 | 15 | 275 | 18 | 265 | 13 | 89 | 6 |
| Completed | 260 | 15 | 256 | 17 | 259 | 13 | 82 | 5 |
| Not completed | 12 | 0 | 19 | 1 | 6 | 0 | 7 | 1 |
| Withdrew: Withdrawal by subject | 6 | 0 | 12 | 1 | 4 | 0 | 6 | 1 |
| Withdrew: Lost to follow-up | 3 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Pregnancy | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Adults | 88 | 103 | 94 | 4 |
| Adolescents | 4 | 8 | 5 | 0 |
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
| Scores on a scale | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects | -19.218 ± 0.651 | -20.312 ± 0.654 | -19.632 ± 0.652 | -9.221 ± 1.135 |
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
| scores on a scale | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS) | -14.92 ± 13.479 | -24.83 ± 12.640 | -18.16 ± 10.246 | -11.94 ± 14.278 |
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.
| scores on a scale | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS) | -8.632 ± 0.298 | -9.023 ± 0.300 | -8.733 ± 0.300 | -4.527 ± 0.522 |
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.
| scores on a scale | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS) | -6.38 ± 6.994 | -12.04 ± 6.264 | -8.56 ± 4.935 | -6.97 ± 7.904 |
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.
| Participants | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Adults | 134 | 153 | 147 | 18 |
| Adolescents | 4 | 9 | 5 | 0 |
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.
| Weeks | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS) | 8.668 ± 0.241 | 8.897 ± 0.246 | 8.427 ± 0.237 | 6.242 ± 0.331 |
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.
| Weeks | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo |
|---|---|---|---|---|
| Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS) | 6.8 ± 4.90 | 8.6 ± 4.60 | 10.2 ± 3.01 | 9.2 ± 4.92 |
Collected over Adverse event (AE) monitoring was continued for at least 30 days following the last dose of study treatment or end of study visit (64 weeks), whichever was longer.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ligelizumab 72mg (Adults) | 0/304 (0%) | 3/304 (1%) | 177/304 (58.2%) |
| Ligelizumab 72mg (Adolescents) | 0/16 (0%) | 0/16 (0%) | 7/16 (43.8%) |
| Ligelizumab 72mg (Adults+Adolescents) | 0/320 (0%) | 3/320 (0.9%) | 184/320 (57.5%) |
| Ligelizumab 120 mg (Adults) | 1/306 (0.3%) | 3/306 (1%) | 182/306 (59.5%) |
| Ligelizumab 120 mg (Adolescents) | 0/19 (0%) | 0/19 (0%) | 10/19 (52.6%) |
| Ligelizumab 120 mg (Adults+Adolescents) | 1/325 (0.3%) | 3/325 (0.9%) | 192/325 (59.1%) |
| Omalizumab 300mg (Adults) | 0/307 (0%) | 2/307 (0.7%) | 165/307 (53.7%) |
| Omalizumab 300mg (Adolescents) | 0/14 (0%) | 0/14 (0%) | 10/14 (71.4%) |
| Omalizumab 300mg (Adults+Adolescents) | 0/321 (0%) | 2/321 (0.6%) | 175/321 (54.5%) |
| Placebo Only (Adults) | 0/103 (0%) | 1/103 (1%) | 40/103 (38.8%) |
| Placebo Only (Adolescents) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Placebo Only (Adults+Adolescents) | 0/109 (0%) | 1/109 (0.9%) | 41/109 (37.6%) |
| Transitioned to Ligelizumab 120mg (Adults) | 0/90 (0%) | 0/90 (0%) | 37/90 (41.1%) |
| Transitioned to Ligelizumab 120mg (Adolescents) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Transitioned to Ligelizumab 120mg (Adults+Adolescents) | 0/96 (0%) | 0/96 (0%) | 39/96 (40.6%) |
| Event | Ligelizumab 72mg (Adults) | Ligelizumab 72mg (Adolescents) | Ligelizumab 72mg (Adults+Adolescents) | Ligelizumab 120 mg (Adults) | Ligelizumab 120 mg (Adolescents) | Ligelizumab 120 mg (Adults+Adolescents) | Omalizumab 300mg (Adults) | Omalizumab 300mg (Adolescents) | Omalizumab 300mg (Adults+Adolescents) | Placebo Only (Adults) | Placebo Only (Adolescents) | Placebo Only (Adults+Adolescents) | Transitioned to Ligelizumab 120mg (Adults) | Transitioned to Ligelizumab 120mg (Adolescents) | Transitioned to Ligelizumab 120mg (Adults+Adolescents) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| UrticariaSkin and subcutaneous tissue disorders | 0/304 | 0/16 | 0/320 | 1/306 | 0/19 | 1/325 | 1/307 | 0/14 | 1/321 | 1/103 | 0/6 | 1/109 | 0/90 | 0/6 | 0/96 |
| AngioedemaSkin and subcutaneous tissue disorders | 2/304 | 0/16 | 2/320 | 0/306 | 0/19 | 0/325 | 0/307 | 0/14 | 0/321 | 0/103 | 0/6 | 0/109 | 0/90 | 0/6 | 0/96 |
| COVID-19Infections and infestations | 1/304 | 0/16 | 1/320 | 2/306 | 0/19 | 2/325 | 0/307 | 0/14 | 0/321 | 0/103 | 0/6 | 0/109 | 0/90 | 0/6 | 0/96 |
| HypertensionVascular disorders | 0/304 | 0/16 | 0/320 | 0/306 | 0/19 | 0/325 | 1/307 | 0/14 | 1/321 | 0/103 | 0/6 | 0/109 | 0/90 | 0/6 | 0/96 |
| Event | Ligelizumab 72mg (Adults) | Ligelizumab 72mg (Adolescents) | Ligelizumab 72mg (Adults+Adolescents) | Ligelizumab 120 mg (Adults) | Ligelizumab 120 mg (Adolescents) | Ligelizumab 120 mg (Adults+Adolescents) | Omalizumab 300mg (Adults) | Omalizumab 300mg (Adolescents) | Omalizumab 300mg (Adults+Adolescents) | Placebo Only (Adults) | Placebo Only (Adolescents) | Placebo Only (Adults+Adolescents) | Transitioned to Ligelizumab 120mg (Adults) | Transitioned to Ligelizumab 120mg (Adolescents) | Transitioned to Ligelizumab 120mg (Adults+Adolescents) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 42/304 | 2/16 | 44/320 | 36/306 | 3/19 | 39/325 | 36/307 | 4/14 | 40/321 | 6/103 | 1/6 | 7/109 | 7/90 | 0/6 | 7/96 |
| HeadacheNervous system disorders | 35/304 | 4/16 | 39/320 | 44/306 | 2/19 | 46/325 | 37/307 | 2/14 | 39/321 | 7/103 | 0/6 | 7/109 | 6/90 | 0/6 | 6/96 |
| PharyngitisInfections and infestations | 4/304 | 0/16 | 4/320 | 4/306 | 0/19 | 4/325 | 3/307 | 0/14 | 3/321 | 1/103 | 0/6 | 1/109 | 1/90 | 1/6 | 2/96 |
| UrticariaSkin and subcutaneous tissue disorders | 13/304 | 0/16 | 13/320 | 17/306 | 0/19 | 17/325 | 11/307 | 1/14 | 12/321 | 4/103 | 0/6 | 4/109 | 1/90 | 1/6 | 2/96 |
| COVID-19Infections and infestations | 17/304 | 0/16 | 17/320 | 16/306 | 2/19 | 18/325 | 10/307 | 2/14 | 12/321 | 1/103 | 0/6 | 1/109 | 4/90 | 0/6 | 4/96 |
| SomnolenceNervous system disorders | 3/304 | 0/16 | 3/320 | 4/306 | 0/19 | 4/325 | 1/307 | 2/14 | 3/321 | 3/103 | 0/6 | 3/109 | 0/90 | 0/6 | 0/96 |
| EczemaSkin and subcutaneous tissue disorders | 12/304 | 0/16 | 12/320 | 12/306 | 0/19 | 12/325 | 10/307 | 2/14 | 12/321 | 1/103 | 0/6 | 1/109 | 0/90 | 0/6 | 0/96 |
| Abdominal pain upperGastrointestinal disorders | 9/304 | 2/16 | 11/320 | 4/306 | 0/19 | 4/325 | 1/307 | 1/14 | 2/321 | 2/103 | 0/6 | 2/109 | 0/90 | 0/6 | 0/96 |
| NauseaGastrointestinal disorders | 13/304 | 2/16 | 15/320 | 10/306 | 1/19 | 11/325 | 8/307 | 1/14 | 9/321 | 2/103 | 0/6 | 2/109 | 0/90 | 0/6 | 0/96 |
| FatigueGeneral disorders | 8/304 | 2/16 | 10/320 | 9/306 | 0/19 | 9/325 | 7/307 | 0/14 | 7/321 | 1/103 | 0/6 | 1/109 | 1/90 | 0/6 | 1/96 |
Randomized set (RAN) included all randomized subjects, regardless of whether or not they received a dose of study drug. Subjects were analyzed according to the treatment they were assigned to.
| Age, Categorical(Participants) | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Adults — <=18 years | 0 | 0 | 0 | 0 | 0 |
| Adults — Between 18 and 65 years | 288 | 278 | 286 | 96 | 948 |
| Adults — >=65 years | 19 | 26 | 23 | 7 | 75 |
| Adolescents — <=18 years | 16 | 19 | 14 | 6 | 55 |
| Adolescents — Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| Adolescents — >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Adults | 41.7 ± 13.42 | 43.0 ± 14.11 | 44.1 ± 14.11 | 42.9 ± 13.01 | 42.9 ± 13.81 |
| Adolescents | 14.3 ± 1.39 | 15.1 ± 1.56 | 15.9 ± 1.17 | 14.8 ± 1.47 | 15.0 ± 1.50 |
| Sex: Female, Male(Participants) | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Adult — Female | 227 | 211 | 225 | 80 | 743 |
| Adult — Male | 80 | 93 | 84 | 23 | 280 |
| Adolescent — Female | 10 | 12 | 10 | 4 | 36 |
| Adolescent — Male | 6 | 7 | 4 | 2 | 19 |
| Race/Ethnicity, Customized(Participants) | Ligelizumab 72 mg | Ligelizumab 120 mg | Omalizumab 300 mg | Placebo | Total |
|---|---|---|---|---|---|
| Adult White | 227 | 218 | 228 | 79 | 752 |
| Adolescent White | 9 | 15 | 10 | 5 | 39 |
| Adult Black or African American | 5 | 12 | 9 | 1 | 27 |
| Adolescent Black or African American | 1 | 0 | 0 | 0 | 1 |
| Adult Asian | 66 | 67 | 63 | 19 | 215 |
| Adolescent Asian | 2 | 2 | 4 | 0 | 8 |
| Adult Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Adolescent Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Adult Native American | 7 | 4 | 6 | 3 | 20 |
| Adolescents Native American | 4 | 2 | 0 | 1 | 7 |
| Adult Multi-racial | 2 | 3 | 3 | 1 | 9 |
| Adolescent Multi-racial | 0 | 0 | 0 | 0 | 0 |
| Adult Race Not Reported | 0 | 0 | 0 | 0 | 0 |
| Adolescent Race Not Reported | 0 | 0 | 0 | 0 | 0 |
Showing the first 100 of 183 sites across 27 countries.
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