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.
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12Primary· Week 12 of the extension study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were need
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
53.5
48.72 – 58.54
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
57.5
52.71 – 62.57
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With Completely Controlled Disease (UAS7 =0) at Week 12Secondary· Week 12 of the extension study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were need
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
37.3
31.63 – 43.04
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
41.5
35.61 – 47.36
Change From Extension Study Baseline in the UAS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core StudiesSecondary· Extension study baseline (Week 0), Week 12 of the extension study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity. A negative change score from extension study ba
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
-19.83
± 13.12
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
-20.41
± 12.94
Change From Extension Study Baseline in the ISS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core StudiesSecondary· Extension study baseline (Week 0), Week 12 of the extension study
The Itch Severity Score (ISS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (intense/severe). A weekly score (ISS7) was derived by adding up the average daily scores of the 7 preceding days. The ISS7 ranged from 0 to 21. A higher ISS7 indicated more severe itching. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the ISS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the ISS7 at Week 12 in all subjects from core
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
-9.12
± 6.35
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
-9.46
± 6.55
Change From Extension Study Baseline in the HSS7 at Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core StudiesSecondary· Extension study baseline (Week 0), Week 12 of the extension study
The Hive Severity Score (HSS) was recorded by the subject twice daily in their eDiary, on a scale of 0 (none) to 3 (\> 12 hives/12 hours). A weekly score (HSS7) was derived by adding up the average daily scores of the 7 preceding days. The HSS7 ranged from 0 to 21 A higher HSS7 indicated a greater number of hives. A negative change score from baseline indicates improvement.
A minimum of 4 out of 7 daily scores were needed to calculate the HSS7 values. Otherwise, the weekly score was missing for that week.
The absolute change from extension study baseline in the HSS7 at Week 12 in all subject
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
-10.71
± 7.50
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
-10.95
± 7.11
Cumulative Number of Angioedema-free Weeks (AAS7=0) up to Week 12 in All Subjects From Core Studies (CQGE031C2302 and CQGE031C2303) Receiving the Same Dose Regimen as in the Core StudiesSecondary· From extension study baseline (Week 0) up to Week 12 of the extension study
The Weekly angioedema activity score (AAS) is a validated tool to assess occurrence of episodes of angioedema. If the subject reported the occurrence of angioedema ("opening question") with "no", AAS score for this day was 0. If "yes" was the answer to the opening question, the subject continued to answer questions about the duration, severity and impact on daily functioning and appearance of the angioedema. A score between 0 and 3 was assigned to every answer field. The AAS7 was the weekly sum of the daily AAS. AAS7 scores ranged from 0-105. Higher score indicated more severe disease.
AAS7 i
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
9.30
± 0.25
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
9.68
± 0.27
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in the Core Studies, With DLQI = 0-1 at Week 12Secondary· Week 12 of the extension study
The Dermatology Life Quality Index (DLQI) is a 10-item dermatology-specific quality of life (QoL) measure. Subjects rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives thinking about the previous 7 days. An overall score was calculated and ranged from 0 to 30. Higher scores indicated worse disease-related QoL. A DLQI score of 0 or 1 indicated that there was no impact of a skin disease on the patient's life.
The percentage of subjects from core studies (CQGE031C2302 and CQGE031C2303) receiving the same dose regimen as in the core stu
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
45.6
39.66 – 51.52
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
55.8
49.77 – 61.79
Percentage of Subjects With Well-controlled Disease (UAS7 ≤ 6) 12 Weeks After Starting Self-administrationSecondary· Week 24 of the extension study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were need
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
69.4
60.86 – 77.07
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
69.5
64.40 – 74.21
Percentage of Subjects From Core Studies (CQGE031C2302 and CQGE031C2303), Receiving the Same Dose Regimen as in Core Studies and Who Achieved UAS7≤ 6 at Week 12 in Core Studies, With Well-controlled Disease (UAS7 ≤ 6) at Week 12 of the Extension StudyPrimary· Week 12 of the extension study
The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals and the intensity of the pruritus over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. UAS7 scores ranged from 0 to 42. A higher UAS7 indicated greater urticaria disease activity.
A minimum of 4 out of 7 daily scores were needed to calculate
Group
Value
95% CI
Ligelizumab 72 mg LIVI -Ligelizumab 120 mg PFS
81.9
74.73 – 87.92
Ligelizumab 120 mg LIVI -Ligelizumab 120 mg PFS
82.6
75.45 – 88.44
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent AEs (TEAEs) were assessed from first dose to 16 weeks post-last dose of each period (below): TRT1A: Within the first 12 weeks of treatment (or up to 16 weeks post-last dose if treatment discontinued), up to 0.5 year. TRT1B: From Week 12 to 52 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.1 years. TRT2: From Week 52 to 104 of treatment (or 16 weeks post-last dose if treatment discontinued), up to 1.3 years. Entire study: up to 2.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this extension study was to establish efficacy and safety of ligelizumab. This was assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who had completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment.
This study also fulfilled the Novartis commitment to provide post-trial access to patients who had completed studies: CQGE031C2302 (NCT03580369), CQGE031C2303 (NCT03580356), CQGE031C2202 (NCT03437278) or CQGE031C1301 (NCT03907878).
Publications & conference data
6 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
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
NCT03580369 — A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately C
· Phase 3
· completed
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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: 20 June 2024
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/NCT04210843.