CompletedNCT03580369Updated Jul 24, 2023Results posted

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

A Phase 3 interventional study of Ligelizumab and Omalizumab in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Completed at 161 sites in 29 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,072
Allocation: Randomized
Ages: 12 Years and older
Sex: All

Study summary

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.

Read the detailed description

This was a Phase III multi-center, randomized, double-blind, active and placebo-controlled, parallel-group study. The study consisted of 3 distinct periods:

Screening period (Day -28 to Day 1): Duration of up to 4 weeks in which subjects who have given informed consent were assessed for eligibility.
Double-blind treatment period (52 weeks): The subjects were seen in the clinic every 4 weeks.
Post-treatment follow-up period (12 weeks): This period consists of 3 visits (every 4 weeks) with the final visit occurring 16 weeks after the last dose at Week 48.

Conditions studied

Chronic Spontaneous Urticaria

Browse trials for

Keywords

Anti-IgE
CSU
chronic spontaneous urticaria
hives severity score
itch severity score
urticaria activity score

In context

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's enrollment of 1,072 is above the median of 61 across 174 interventional studies indexed under Urticaria.

Browse Urticaria studies →

Lead sponsor

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.

Who can participate

Ages eligible: 12 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study. The subject's, parent's or legal guardian's signed written informed consent and child's assent, if appropriate, must be obtained before any assessment is performed. Of note, if the subject reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Male and female subjects ≥ 12 years of age at the time of screening.
CSU diagnosis for ≥ 6 months.
Diagnosis of CSU refractory to H1-AH at approved doses at the time of randomization, as defined by all of the following:
The presence of itch and hives for ≥ 6 consecutive weeks at any time prior to Visit 1 (Day - 28 to Day -14) despite current use of non-sedating H1-antihistamine
UAS7 score (range 0-42) ≥ 16 and HSS7 (range 0-21) ≥ 8 during the 7 days prior to randomization (Visit 110, Day 1)
Subjects must be on H1-antihistamine at only locally label approved doses for treatment of CSU starting at Visit 1 (Day -28 to Day -14)
Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Key Exclusion Criteria:

History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes (i.e. to murine, chimeric or human antibodies).
Subjects having a clearly defined cause of their chronic urticaria, other than CSU. This includes, but is not limited to, the following: symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic- or contact-urticaria.
Diseases, other than chronic urticaria, with urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg, due to C1 inhibitor deficiency).
Subjects with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. All subjects will be screened at Visit 1. If stool testing is positive for pathogenic organism, the subject will not be randomized and will not be allowed to rescreen.
Any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results (e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
Prior exposure to ligelizumab or omalizumab.
H1-AH used as background medication at greater than locally label-approved doses after visit 1

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,072 participants (actual)

Study arms

Experimental
Ligelizumab 120 mg
Ligelizumab 120 mg arm: 1 injection of 1.0 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Experimental
Ligelizumab 72 mg
Ligelizumab 72 mg arm: 1 injection of 0.6 mL ligelizumab + 1 injection of 1.0 mL ligelizumab placebo q4w
Biological: Ligelizumab
Active comparator
Omalizumab 300 mg
Omalizumab 300 mg arm: 2 injections of 1.2 mL omalizumab q4w
Biological: Omalizumab
Placebo comparator
Placebo
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

Interventions

BiologicalLigelizumab
Liquid in vial
BiologicalOmalizumab
Lyophilized powder for solution in vial
OtherPlacebo
Liquid in vial

What researchers measure

Primary outcomes

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

Secondary outcomes

Number and Proportion 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. 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 Proportion 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, 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.
Time frame: Baseline, 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

Results

Posted Dec 30, 2022

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).

Participant flow

1,072 participants enrolled at 164 sites in 28 countries

Participant flow — Overall Study
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 - Adolesecents
Started	307	10	312	12	309	13	106	3
Completed	263	10	258	9	267	10	91	3
Not completed	44	0	54	3	42	3	15	0
Withdrew: No treatment due to mis-randomization	1	0	0	0	3	0	0	0
Withdrew: Reason unknown	0	0	1	0	0	0	0	0
Withdrew: Technical problems	0	0	0	0	1	0	2	0
Withdrew: Pregnancy	2	0	3	0	2	0	0	0
Withdrew: Lost to follow-up	2	0	2	0	3	0	1	0
Withdrew: Physician decision	4	0	4	1	1	0	0	0
Withdrew: Lack of efficacy	3	0	7	0	2	0	3	0
Withdrew: Protocol violation	6	0	6	1	8	2	1	0
Withdrew: Adverse event	7	0	14	1	6	0	1	0
Withdrew: Withdrawal by subject	19	0	17	0	16	1	7	0

Outcome measures

PrimaryMean 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
Reported as:: Least squares mean · Score

Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects
Score	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo
Mean Change From Baseline in UAS7 at Week 12 (Multiple Imputation) of Adult Subjects	-19.368 ± 0.668	-19.330 ± 0.660	-20.040 ± 0.663	-11.366 ± 1.129

Statistical analysis

Ligelizumab 72 mg vs Placebo · Mixed Models Analysis · p = <.0001 · Ls mean: -8.002 · 95% CI -10.576 to -5.428Linear mixed model with repeated measures (MMRM)
Ligelizumab 72 mg vs Omalizumab 300 mg · Mixed Models Analysis · p = 0.7628 · Ls mean: 0.672 · 95% CI -1.169 to 2.513Linear mixed model with repeated measures (MMRM)
Ligelizumab 120 mg vs Placebo · Mixed Models Analysis · p = <.0001 · Ls mean: -7.964 · 95% CI -10.522 to -5.047Linear mixed model with repeated measures (MMRM)
Ligelizumab 120 mg vs Omalizumab 300 mg · Mixed Models Analysis · p = 0.7768 · Ls mean: 0.710 · 95% CI -1.118 to 2.538Linear mixed model with repeated measures (MMRM)

PrimaryMean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)

Time frame:: Baseline, Week 12
Reported as:: Mean · Score

Mean Change From Baseline in UAS7 at Week 12 (Observed Data) of Adolescent Subjects (FAS)
Score	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)	-17.39 ± 13.070	-14.64 ± 14.662	-13.84 ± 15.343	-12.75 ± 18.738

SecondaryNumber and Proportion 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. No Statistical analysis was planned for adolescent group.

Time frame:: Week 12
Reported as:: Count of participants · Participants

Number and Proportion of Subjects With UAS7=0 Response at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Participants	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo
Adults	102	104	116	8
Adolescents	3	3	0	1

Statistical analysis

Ligelizumab 72 mg vs Placebo · Regression, Logistic · p = <.0001 · Odds ratio (or): 5.680 · 95% CI 2.667 to 12.09595% confidence interval for the odds ratio
Ligelizumab 72 mg vs Omalizumab 300 mg · Regression, Logistic · p = 0.8430 · Odds ratio (or): 0.840 · 95% CI 0.598 to 1.18095% confidence interval for the odds ratio
Ligelizumab 120 mg vs Placebo · Regression, Logistic · p = <.0001 · Odds ratio (or): 5.734 · 95% CI 2.694 to 12.20795% confidence interval for the odds ratio
Ligelizumab 120 mg vs Omalizumab 300 mg · Regression, Logistic · p = 0.8312 · Odds ratio, log: 0.848 · 95% CI 0.605 to 1.18895% confidence interval for the odds ratio

SecondaryMean 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
Reported as:: Least squares mean · score

Mean Change From Baseline in ISS7 at Week 12 (Multiple Imputation) of Adult Subjects (FAS)
score	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)	-8.502 ± 0.305	-8.532 ± 0.301	-8.921 ± 0.302	-5.402 ± 0.514

Statistical analysis

Ligelizumab 120 mg vs Placebo · Mixed Models Analysis · p = <.0001 · Ls mean: -3.100 · 95% CI -4.271 to -1.929Linear mixed model with repeated measures (MMRM)
Ligelizumab 72 mg vs Omalizumab 300 mg · Mixed Models Analysis · p = 0.8366 · Ls mean: 0.419 · 95% CI -0.419 to 1.258Linear mixed model with repeated measures (MMRM)
Ligelizumab 120 mg vs Placebo · Mixed Models Analysis · p = <.0001 · Ls mean: -3.130 · 95% CI -4.295 to -1.966Linear mixed model with repeated measures (MMRM)
Ligelizumab 120 mg vs Omalizumab 300 mg · Mixed Models Analysis · p = 0.8201 · Ls mean: 0.389 · 95% CI -0.444 to 1.222Linear mixed model with repeated measures (MMRM)

SecondaryMean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)

Time frame:: Baseline, Week 12
Reported as:: Mean · score

Mean Change From Baseline in ISS7 at Week 12 (Observed Data) of Adolescent Subjects, (FAS)
score	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)	-8.40 ± 6.779	-6.82 ± 7.404	-5.10 ± 7.153	-7.00 ± 9.899

SecondaryNumber and Proportion 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, 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.

Time frame:: Baseline, Week 12
Reported as:: Count of participants · Participants

Number and Proportion of Participants With DLQI Score of 0 - 1 at Week 12 (Multiple Imputation - Adults, Observed Data for Adolescents)
Participants	Ligelizumab 72 mg	Ligelizumab 120 mg	Omalizumab 300 mg	Placebo
Adults	133	150	147	22
Adolescents	3	6	2	1

Statistical analysis

Ligelizumab 72 mg vs Placebo · Regression, Logistic · p = <.0001 · Odds ratio (or): 2.747 · 95% CI 1.621 to 4.65695% confidence interval for the odds ratio
Ligelizumab 72 mg vs Omalizumab 300 mg · Regression, Logistic · p = 0.8586 · Odds ratio (or): 0.836 · 95% CI 0.603 to 1.15995% confidence interval for the odds ratio
Ligelizumab 120 mg vs Placebo · Regression, Logistic · p = <.0001 · Odds ratio (or): 3.261 · 95% CI 1.929 to 5.51395% confidence interval for the odds ratio
Ligelizumab 120 mg vs Omalizumab 300 mg · Regression, Logistic · p = 0.5190 · Odds ratio (or): 0.992 · 95% CI 0.717 to 1.37395% confidence interval for the odds ratio

SecondaryCumulative 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
Reported as:: Least squares mean · Weeks

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Multiple Imputation) of Adult Subjects (FAS)
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)	8.568 ± 0.235	8.912 ± 0.239	8.790 ± 0.239	6.475 ± 0.327

Statistical analysis

Ligelizumab 72 mg vs Placebo · Negative binomial regression model · p = <.0001 · Risk ratio (rr): 1.323 · 95% CI 1.183 to 1.48095% confidence interval for the relative risk ratio
Ligelizumab 72 mg vs Omalizumab 300 mg · Negative binomial regression model · p = 0.7469 · Risk ratio (rr): 0.975 · 95% CI 0.904 to 1.05195% confidence interval for the relative risk ratio
Ligelizumab 120 mg vs Placebo · Negative binomial regression model · p = <.0001 · Risk ratio (rr): 1.376 · 95% CI 1.230 to 1.54095% confidence interval for the relative risk ratio
Ligelizumab 120 mg vs Omalizumab 300 mg · Negative binomial regression model · p = 0.3586 · Risk ratio (rr): 1.014 · 95% CI 0.941 to 1.09295% confidence interval for the relative risk ratio

SecondaryCumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)

Time frame:: Baseline, Week 12
Reported as:: Least squares mean · Weeks

Cumulative Number of Weeks of AAS7=0 up to Week 12 (Observed Data) of Adolescent Subjects (FAS)
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)	6.0 ± 4.94	7.3 ± 5.44	9.0 ± 3.50	11.0 ± 0.00

Adverse events

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 is longer.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
QGE031 72mg	0/316 (0%)	22/316 (7%)	178/316 (56.3%)
QGE031 120mg	0/324 (0%)	32/324 (9.9%)	182/324 (56.2%)
Omalizumab 300mg	0/319 (0%)	23/319 (7.2%)	206/319 (64.6%)
Placebo Only	0/109 (0%)	3/109 (2.8%)	38/109 (34.9%)
Transitioned to QGE031 120mg	0/102 (0%)	4/102 (3.9%)	43/102 (42.2%)

Most frequent serious events

Showing 10 of 76

Most frequent serious events
Event	QGE031 72mg	QGE031 120mg	Omalizumab 300mg	Placebo Only	Transitioned to QGE031 120mg
Kidney infectionInfections and infestations	0/316	0/324	0/319	0/109	1/102
NasopharyngitisInfections and infestations	0/316	0/324	0/319	0/109	1/102
Pyelonephritis acuteInfections and infestations	0/316	0/324	0/319	0/109	1/102
UrticariaSkin and subcutaneous tissue disorders	1/316	2/324	0/319	1/109	1/102
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders	3/316	0/324	0/319	0/109	0/102
COVID-19Infections and infestations	0/316	3/324	1/319	0/109	0/102
SarcoidosisImmune system disorders	0/316	0/324	0/319	1/109	0/102
Loss of consciousnessNervous system disorders	0/316	0/324	0/319	1/109	0/102
Urinary tract infectionInfections and infestations	2/316	1/324	0/319	0/109	0/102
COVID-19 pneumoniaInfections and infestations	1/316	0/324	2/319	0/109	0/102

Most frequent other events

Showing 10 of 44

Most frequent other events
Event	QGE031 72mg	QGE031 120mg	Omalizumab 300mg	Placebo Only	Transitioned to QGE031 120mg
HeadacheNervous system disorders	40/316	30/324	39/319	6/109	4/102
NasopharyngitisInfections and infestations	35/316	32/324	38/319	10/109	8/102
Upper respiratory tract infectionInfections and infestations	20/316	24/324	28/319	4/109	1/102
Injection site reactionGeneral disorders	15/316	15/324	7/319	0/109	6/102
ArthralgiaMusculoskeletal and connective tissue disorders	9/316	19/324	16/319	1/109	5/102
DiarrhoeaGastrointestinal disorders	10/316	9/324	18/319	4/109	3/102
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	9/316	7/324	18/319	2/109	1/102
UrticariaSkin and subcutaneous tissue disorders	17/316	15/324	10/319	2/109	3/102
Back painMusculoskeletal and connective tissue disorders	12/316	9/324	16/319	1/109	0/102
Urinary tract infectionInfections and infestations	11/316	10/324	12/319	3/109	5/102

Baseline characteristics

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. Adults (1,034) + Adolescents (38) = Total (1,072)

Age, Categorical
Age, Categorical(Participants)	Ligelizumab 120 mg	Ligelizumab 72 mg	Omalizumab 300 mg	Placebo	Total
<=18 years	10	12	13	3	38
Between 18 and 65 years	288	297	291	95	971
>=65 years	19	15	18	11	63

Age, Continuous
Age, Continuous(Years)	Ligelizumab 120 mg	Ligelizumab 72 mg	Omalizumab 300 mg	Placebo	Total
Adults	42.3 ± 13.48	43.3 ± 13.12	42.2 ± 13.19	43.2 ± 14.06	42.7 ± 13.34
Adolescents	14.6 ± 2.01	15.1 ± 1.62	14.7 ± 1.65	15.3 ± 2.08	14.8 ± 1.72

Sex: Female, Male
Sex: Female, Male(Participants)	Ligelizumab 120 mg	Ligelizumab 72 mg	Omalizumab 300 mg	Placebo	Total
Adult — Female	217	226	218	76	737
Adult — Male	90	86	91	30	297
Adolescent — Female	5	9	9	1	24
Adolescent — Male	5	3	4	2	14

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Ligelizumab 120 mg	Ligelizumab 72 mg	Omalizumab 300 mg	Placebo	Total
Adult White	226	220	221	80	747
Adolescent White	8	8	8	2	26
Adult Black or African American	1	4	9	1	15
Adolescent Black or African American	0	1	0	0	1
Adult Asian	60	72	64	22	218
Adolescent Asian	0	3	2	0	5
Adult Native Hawaiian or Other Pacific Islander	0	1	0	0	1
Adolescent Native Hawaiian or Pacific Islander	0	0	0	0	0
Adult Native American	12	10	9	3	34
Adolescents Native American	2	0	3	1	6
Adult Multi-racial	6	4	6	0	16
Adolescent Multi-racial	0	0	0	0	0
Adult Race Not Reported	2	1	0	0	3
Adolescent Race Not Reported	0	0	0	0	0

Study locations

161 sites

Novartis Investigative Site
Gilbert, Arizona 85234, United States
Novartis Investigative Site
Litchfield Park, Arizona 85340, United States
Novartis Investigative Site
Scottsdale, Arizona 85258, United States
Novartis Investigative Site
Little Rock, Arkansas 72205, United States
Novartis Investigative Site
Bakersfield, California 93301, United States
Novartis Investigative Site
Huntington Beach, California 92647, United States
Novartis Investigative Site
Long Beach, California 90808, United States
Novartis Investigative Site
Colorado Springs, Colorado 80907, United States
Novartis Investigative Site
Denver, Colorado 80230, United States
Novartis Investigative Site
Greenacres City, Florida 33467, United States
Novartis Investigative Site
Tallahassee, Florida 32308, United States
Novartis Investigative Site
Tampa, Florida 33613, United States
Novartis Investigative Site
Boise, Idaho 83706, United States
Novartis Investigative Site
Evansville, Indiana 47713, United States
Novartis Investigative Site
Indianapolis, Indiana 46256, United States
Novartis Investigative Site
Overland Park, Kansas 66211, United States
Novartis Investigative Site
Bangor, Maine 04401, United States
Novartis Investigative Site
Waldorf, Maryland 20602, United States
Novartis Investigative Site
Clarkston, Michigan 48346, United States
Novartis Investigative Site
Ypsilanti, Michigan 48197, United States
Novartis Investigative Site
Plymouth, Minnesota 55441, United States
Novartis Investigative Site
Asheville, North Carolina 28801, United States
Novartis Investigative Site
Cincinnati, Ohio 45231, United States
Novartis Investigative Site
Tulsa, Oklahoma 74136, United States
Novartis Investigative Site
Medford, Oregon 97504, United States
Novartis Investigative Site
Dallas, Texas 75230, United States
Novartis Investigative Site
Dallas, Texas 75231, United States
Novartis Investigative Site
Pflugerville, Texas 78660, United States
Novartis Investigative Site
San Antonio, Texas 78229, United States
Novartis Investigative Site
South Burlington, Vermont 05403, United States
Novartis Investigative Site
Caba, Buenos Aires C1056ABJ, Argentina
Novartis Investigative Site
Caba, Buenos Aires C1414AIF, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1425BEA, Argentina
Novartis Investigative Site
La Plata, Buenos Aires B1902COS, Argentina
Novartis Investigative Site
Buenos Aires, Nueve De Julio B6500BWQ, Argentina
Novartis Investigative Site
Bahia Blanca, B8000JRB, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Capital Federal, C1023AAB, Argentina
Novartis Investigative Site
Innsbruck, 6020, Austria
Novartis Investigative Site
Wien, A 1090, Austria
Novartis Investigative Site
Vitoria, ES 29025 023, Brazil
Novartis Investigative Site
Alphaville Barueri, Sao Paulo 06454010, Brazil
Novartis Investigative Site
Santo Andre, SP 09060 650, Brazil
Novartis Investigative Site
Sao Paulo, SP 05403 000, Brazil
Novartis Investigative Site
Pleven, 5800, Bulgaria
Novartis Investigative Site
Sofia, 1407, Bulgaria
Novartis Investigative Site
Sofia, 1431, Bulgaria
Novartis Investigative Site
Sofia, 1606, Bulgaria
Novartis Investigative Site
Varna, 9000, Bulgaria
Novartis Investigative Site
Hamilton, Ontario L8N 3Z5, Canada
Novartis Investigative Site
Kingston, Ontario K7L 2V7, Canada
Novartis Investigative Site
Mississauga, Ontario L5A 3V4, Canada
Novartis Investigative Site
Toronto, Ontario M3B 3S6, Canada
Novartis Investigative Site
Waterloo, Ontario N2J 1C4, Canada
Novartis Investigative Site
Montreal, Quebec H2V 2K1, Canada
Novartis Investigative Site
Quebec, G1V 4W2, Canada
Novartis Investigative Site
Medellin, Antioquia 0050010, Colombia
Novartis Investigative Site
Bogota, 110221, Colombia
Novartis Investigative Site
Zagreb, 10000, Croatia
Novartis Investigative Site
Teplice, CZE 415 01, Czechia
Novartis Investigative Site
Prague, Prague 1 11000, Czechia
Novartis Investigative Site
Olomouc, 775 20, Czechia
Novartis Investigative Site
Plzen, 305 99, Czechia
Novartis Investigative Site
Copenhagen NV, 2400, Denmark
Novartis Investigative Site
Herlev, 2730, Denmark
Novartis Investigative Site
Bordeaux Cedex, 33075, France
Novartis Investigative Site
Montpellier cedex 5, 34295, France
Novartis Investigative Site
Pierre Benite Cedex, 69495, France
Novartis Investigative Site
Toulouse, 31400, France
Novartis Investigative Site
Trevenans, 90400, France
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Bochum, 44791, Germany
Novartis Investigative Site
Bochum, 44793, Germany
Novartis Investigative Site
Erlangen, 91054, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Freiburg, 79106, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Langenau, 89129, Germany
Novartis Investigative Site
Mainz, 55131, Germany
Novartis Investigative Site
Marburg, 35039, Germany
Novartis Investigative Site
Memmingen, 87700, Germany
Novartis Investigative Site
Muenchen, 81377, Germany
Novartis Investigative Site
Oldenburg, 26133, Germany
Novartis Investigative Site
Athens, GR 115 27, Greece
Novartis Investigative Site
Athens, 115 27, Greece
Novartis Investigative Site
Athens, 12462, Greece
Novartis Investigative Site
Athens, 161 21, Greece
Novartis Investigative Site
Guatemala City, 01010, Guatemala
Novartis Investigative Site
Guatemala City, 1015, Guatemala
Novartis Investigative Site
Kecskemet, Bacs Kiskun 6000, Hungary
Novartis Investigative Site
Szeged, Csongrad 6720, Hungary
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Pecs, 7623, Hungary
Novartis Investigative Site
Belagavi, Karnataka 590010, India
Novartis Investigative Site
Nashik, Maharashtra 422 101, India
Novartis Investigative Site
Nashik, Maharashtra 422005, India
Novartis Investigative Site
Navi Mumbai, Maharashtra 400 706, India
Novartis Investigative Site
New Delhi, 110029, India
Novartis Investigative Site
Vijayawada, 520002, India
Novartis Investigative Site
Daegu, Dalseo Gu 42602, Korea, Republic of

Showing the first 100 of 161 sites across 29 countries.

References and documents

Study documents

Study protocol · Jan 7, 2021
Statistical analysis plan · Jul 1, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03580369
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Jul 9, 2018
Start date: Oct 17, 2018
Primary completion: Jul 16, 2021
Completion: Jun 14, 2022
Results posted: Dec 30, 2022
Last update: Jul 24, 2023

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urticaria→

Other studies from this sponsor

Novartis Pharmaceuticals

Start the discussion

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Study summary

Conditions studied

Browse trials for

Keywords

In context

Urticaria

Lead sponsor

Who can participate

Eligibility criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Related links

Study documents

Individual participant data

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor