A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
CompletedPhase 3Results postedLast updated 24 July 2023
What this trial tests
Phase 3 trial testing Ligelizumab in Chronic Spontaneous Urticaria in 1,072 participants. Completed in 14 June 2022.
12 and older, any sex, with Chronic Spontaneous Urticaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult SubjectsPrimary· 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 Sc
Group
Value
95% CI
Ligelizumab 72 mg
-19.368
± 0.668
Ligelizumab 120 mg
-19.330
± 0.660
Omalizumab 300 mg
-20.040
± 0.663
Placebo
-11.366
± 1.129
Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)Primary· 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 Sc
Group
Value
95% CI
Ligelizumab 72 mg
-17.39
± 13.070
Ligelizumab 120 mg
-14.64
± 14.662
Omalizumab 300 mg
-13.84
± 15.343
Placebo
-12.75
± 18.738
Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)Secondary· 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.
Adults
Group
Value
95% CI
Ligelizumab 72 mg
102
Ligelizumab 120 mg
104
Omalizumab 300 mg
116
Placebo
8
Adolescents
Group
Value
95% CI
Ligelizumab 72 mg
3
Ligelizumab 120 mg
3
Omalizumab 300 mg
0
Placebo
1
Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)Secondary· 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.
Group
Value
95% CI
Ligelizumab 72 mg
-8.502
± 0.305
Ligelizumab 120 mg
-8.532
± 0.301
Omalizumab 300 mg
-8.921
± 0.302
Placebo
-5.402
± 0.514
Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)Secondary· 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 adolescen
Group
Value
95% CI
Ligelizumab 72 mg
-8.40
± 6.779
Ligelizumab 120 mg
-6.82
± 7.404
Omalizumab 300 mg
-5.10
± 7.153
Placebo
-7.00
± 9.899
Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)Secondary· 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.
Adults
Group
Value
95% CI
Ligelizumab 72 mg
133
Ligelizumab 120 mg
150
Omalizumab 300 mg
147
Placebo
22
Adolescents
Group
Value
95% CI
Ligelizumab 72 mg
3
Ligelizumab 120 mg
6
Omalizumab 300 mg
2
Placebo
1
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)Secondary· 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.
Group
Value
95% CI
Ligelizumab 72 mg
8.568
± 0.235
Ligelizumab 120 mg
8.912
± 0.239
Omalizumab 300 mg
8.790
± 0.239
Placebo
6.475
± 0.327
Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)Secondary· 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.
Group
Value
95% CI
Ligelizumab 72 mg
6.0
± 4.94
Ligelizumab 120 mg
7.3
± 5.44
Omalizumab 300 mg
9.0
± 3.50
Placebo
11.0
± 0.00
Adverse events — posted to ClinicalTrials.gov
Time frame: 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 is longer..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
QGE031 72mg
Serious: 22/316 (7%)
Deaths: 0/316
QGE031 120mg
Serious: 32/324 (10%)
Deaths: 0/324
Omalizumab 300mg
Serious: 23/319 (7%)
Deaths: 0/319
Placebo Only
Serious: 3/109 (3%)
Deaths: 0/109
Transitioned to QGE031 120mg
Serious: 4/102 (4%)
Deaths: 0/102
Serious adverse events (76 terms)
Reaction
System
QGE031 72mg
QGE031 120mg
Omalizumab 300mg
Placebo Only
Transitioned to QGE031 120mg
COVID-19
Infections and infestations
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Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
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Anaphylactic reaction
Immune system disorders
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Bronchitis
Infections and infestations
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COVID-19 pneumonia
Infections and infestations
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Urinary tract infection
Infections and infestations
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Concussion
Injury, poisoning and procedural complications
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Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo.
The study population consisted of 1,072 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05024058 — Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Sympto
· Phase 3
· terminated
NCT04513548 — Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria
· Phase 1
· terminated
NCT04210843 — Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study Wit
· Phase 3
· terminated
NCT03907878 — A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1-
· Phase 3
· completed
NCT03580356 — A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controll
· Phase 3
· completed
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Currently open trials in the same condition.
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NCT07219615 — A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 24 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03580369.