A Phase 2 interventional study of Ligelizumab and Placebo in Chronic Spontaneous Urticaria, sponsored by Novartis Pharmaceuticals. Completed at 20 sites in 10 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Among 37 studies in Chronic Urticaria by Novartis Pharmaceuticals — 7 open to participants now, 12 under way, 5 of them phase 3. Chronic Urticaria · Novartis Pharmaceuticals.
Among the 37 studies in Chronic Urticaria by Novartis Pharmaceuticals, this one is the 22nd largest by enrollment of the 25 interventional ones that give a count, is one of 3 that started in 2018, is one of 7 in phase 2, and was the 10th registered.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
Browse Chronic Urticaria studies →7 of the 37 studies in Chronic Urticaria by Novartis Pharmaceuticals are open now, in 9 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Canada, Hong Kong, Japan and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in Germany
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18–100
Novartis Pharmaceuticals · Sites in United States
Ages 18–100
By country, each count listing its studies:
Of the 24 Chronic Urticaria studies recruiting now, 11 (46%) set no upper age limit and 9 (38%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.
This study: 12 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 49 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Median enrollment 311 across the 25 interventional studies, 484 across the 10 observational. Of the 23 that completed or were terminated, 18 (78%) have results posted.
This tab as a report to print or save as PDF → With an account.
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
2 of the studies in Chronic Urticaria by Novartis Pharmaceuticals that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06868212Phase 3Novartis PharmaceuticalsA Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines | 2027-02-22 |
| NCT06865651Novartis PharmaceuticalsStudy of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria | 2027-08-23 |
Among the 37 studies in Chronic Urticaria by Novartis Pharmaceuticals, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to \< 18 years of age, with chronic spontaneous urticaria (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses of H1 antihistamines (H1AH) following the guideline on treatment of CSU.
This was a Phase IIb dose-finding, randomized, double-blind, parallel-group, placebo-controlled, multicenter study in adolescent patients. The study consisted of 3 distinct study periods: Screening, Treatment and Follow-up period.
After the screening period (up to 4 weeks), at Day 1 participants were randomized into one of the three treatment arms in 1:2:1 fashion to ligelizumab high dose (120 mg every four weeks (q4w)) versus ligelizumab low dose (24 mg q4w) versus placebo. During the 24 weeks of treatment period, doses were administered on Day 1 then on weeks 4, 8, 12, 16, and 20 weeks after randomization. Participants randomized to placebo received placebo on Day 1, Weeks 4 and 8; thereafter they received 120 mg ligelizumab (high dose) on Weeks 12, 16 and 20 such that by the end of the study, the same number of participants received ligelizumab high dose as low dose. The treatment period was followed by a treatment-free follow-up period of 16 weeks to a maximum of Week 40.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of CSU to approved doses of H1-antihistamines at the time of randomization, as defined by all of the following:
Exclusion Criteria:
Clearly defined underlying etiology for chronic urticarias other than CSU. This includes the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
Drug: Ligelizumab
Participants received a dose of ligelizumab 24 mg (low dose) which consisted of one injection of 0.2 ml of ligelizumab 120 mg/ 1 ml vial every 4 weeks from Day 1 to Week 20 (inclusive).
Drug: Ligelizumab
Participants received Placebo which consisted of one injection of 1 ml placebo every 4 weeks from Day 1 to Week 8 (inclusive). From week 12 to week 20 (inclusive), participants received a dose of ligelizumab 120 mg (high dose) which consisted of one injection of 1 ml of ligelizumab 120 mg/ 1 ml vial.
Drug: Ligelizumab · Drug: Placebo
Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg or 24 mg, high and low doses respectively.
Also known as: QGE031
Placebo 0 mg per 1 ml liquid injection once every 4 weeks.
Change From Baseline of Weekly Urticaria Activity Score (UAS7) at Week 24
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
Time frame: Baseline, week 24
Change From Baseline of Weekly Urticaria Activity Score (UAS7) at Weeks 12 and 40
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
Time frame: Baseline, weeks 12 and 40
Percentage of Participants With Complete Response in Weekly Urticaria Activity Score (UAS7)
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A complete UAS7 response is defined as UAS7=0, no wheals neither pruritus. Participants with post-baseline missing data were considered as non-responders.
Time frame: Weeks 12, 24 and 40
Change From Baseline of Weekly Itch Severity Score (ISS7)
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
Time frame: Baseline, weeks 12, 24 and 40
Percentage of Participants With Complete Response in Weekly Itch Severity Score (ISS7)
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
Time frame: Weeks 12, 24 and 40
Change From Baseline of Weekly Hives Severity Score (HSS7)
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
Time frame: Baseline, weeks 12, 24 and 40
Percentage of Participants With Complete Response in Weekly Hives Severity Score (HSS7)
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
Time frame: Weeks 12, 24 and 40
Change From Baseline of the Children Dermatology Life Quality Index (CDLQI)
The children dermatology life quality index questionnaire is a 10-item dermatology- specific health-related quality of life measure designed for use in children. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. The CDLQI total score is a sum of all 10 item responses, each individual response ranging from 0 (not at all) to 3 (very much). Total score ranges from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change score from baseline indicates improvement. Baseline was defined as the last non-missing value prior to or on the first treatment date. To handle the missing data, if a participant had only one item missing score per visit, then it was imputed to 0 and total score was calculated accordingly. If there were 2 or more item missing scores per visit, then the total score for the visit was considered as missing.
Time frame: Baseline, weeks 12, 24 and 40
Change From Baseline in Total Human Immunoglobulin E (IgE)
Change from baseline in IgE (free IgE plus IgE bound to ligelizumab) at weeks 12, 24 and 40 as a pharmacodynamic measurement.
Time frame: Baseline, weeks 12, 24 and 40
Apparent Clearance (CL/F) of Ligelizumab Estimated With a PopPK Model
Model-based estimate of apparent clearance (CL/F) was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent clearance population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
Time frame: Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
Apparent Volume of Distribution of Ligelizumab Estimated With a PopPK Model
Model-based estimate of apparent volume of distribution was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent volume of distribution population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
Time frame: Weeks 0 (baseline), 4, 8, 12, 16, 20 (all pre-dose) and weeks 24, 32 and 40
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including significant changes from baseline in vital signs (blood pressure, pulse rate), electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category is reported in the table.
Time frame: From the start of treatment to 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks
Participants were recruited from 20 sites: Argentina (3), Belgium (1), Canada (2), Germany (2), Hungary (1), India (3), Russia (3), Spain (2), Taiwan (1) and Turkey (2).
| Milestone | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Started | 24 | 13 | 12 |
| Completed | 22 | 13 | 10 |
| Not completed | 2 | 0 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Progressive disease | 1 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 1 |
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
| Score on a scale | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Change From Baseline of Weekly Urticaria Activity Score (UAS7) at Week 24 | -20.36 ± 12.963 | -22.50 ± 13.503 | -21.26 ± 14.480 |
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
| Score on a scale | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | -15.70 ± 10.867 | -18.38 ± 12.268 | -12.96 ± 13.043 |
| Week 40 | -17.50 ± 12.619 | -15.65 ± 11.096 | -19.43 ± 17.667 |
UAS7 is a self-reported scoring system to evaluate urticaria signs and symptoms. UAS7 is the sum of daily urticaria activity scores (UAS) over a seven-day period. The possible range of UAS7 score is 0 to 42 (0 to 6 for daily UAS x 7 days). A higher urticaria activity score indicates more severe symptoms. A complete UAS7 response is defined as UAS7=0, no wheals neither pruritus. Participants with post-baseline missing data were considered as non-responders.
| Participants | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | 4 | 5 | 2 |
| Week 24 | 8 | 8 | 4 |
| Week 40 | 3 | 2 | 4 |
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
| Score on a scale | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | -7.66 ± 5.824 | -7.81 ± 6.047 | -6.34 ± 6.936 |
| Week 24 | -9.71 ± 7.049 | -9.85 ± 6.488 | -10.28 ± 7.811 |
| Week 40 | -8.73 ± 6.656 | -6.86 ± 5.848 | -9.88 ± 8.687 |
ISS7 is the sum of daily Itch Severity Score (ISS) over a seven-day period. The possible range of ISS7 score is 0-21 (0-3 for daily ISS x 7 days), where 0 is defined as complete ISS7 response (no itching) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
| Participants | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | 4 | 5 | 2 |
| Week 24 | 9 | 8 | 4 |
| Week 40 | 4 | 2 | 4 |
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. A negative change score from baseline indicates improvement. Baseline was calculated using data from the 7 days prior to the first treatment date. To handle the missing data, if a participant had at least 4 non-missing daily scores within the 7 days prior to a study visit, the weekly score was calculated as the sum of the available scores in that week, divided by the number of days with daily scores available, multiplied by 7. However, if there were less than 4 non-missing daily scores within the prior 7 days, then the weekly score was missing for the week.
| Score on a scale | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | -8.03 ± 6.307 | -10.58 ± 7.225 | -6.62 ± 6.385 |
| Week 24 | -10.65 ± 6.673 | -12.65 ± 7.785 | -10.98 ± 6.842 |
| Week 40 | -8.77 ± 6.770 | -8.78 ± 6.084 | -9.55 ± 9.197 |
HSS7 is the sum of daily Hives Severity Score (HSS) over a seven-day period. The possible range of HSS7 score is 0-21 (0-3 for daily HSS x 7 days), where 0 is defined as complete HSS7 response (no wheals) and 21 is the worst score. Participants with post-baseline missing data were considered as non-responders.
| Participants | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | 6 | 6 | 2 |
| Week 24 | 10 | 9 | 4 |
| Week 40 | 5 | 2 | 5 |
The children dermatology life quality index questionnaire is a 10-item dermatology- specific health-related quality of life measure designed for use in children. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. The CDLQI total score is a sum of all 10 item responses, each individual response ranging from 0 (not at all) to 3 (very much). Total score ranges from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change score from baseline indicates improvement. Baseline was defined as the last non-missing value prior to or on the first treatment date. To handle the missing data, if a participant had only one item missing score per visit, then it was imputed to 0 and total score was calculated accordingly. If there were 2 or more item missing scores per visit, then the total score for the visit was considered as missing.
| Score on a scale | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | -10.1 ± 4.88 | -6.6 ± 8.05 | -5.0 ± 6.23 |
| Week 24 | -11.5 ± 6.85 | -8.8 ± 10.43 | -10.1 ± 6.74 |
| Week 40 | -10.3 ± 6.86 | -5.5 ± 9.04 | -8.6 ± 8.54 |
Change from baseline in IgE (free IgE plus IgE bound to ligelizumab) at weeks 12, 24 and 40 as a pharmacodynamic measurement.
| International units / millilitre | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| Week 12 | 186 ± 160 | 245 ± 291 | -43.1 ± 56.2 |
| Week 24 | 169 ± 126 | 328 ± 504 | 325 ± 411 |
| Week 40 | 30.4 ± 105 | -15.6 ± 118 | -22.0 ± 93.0 |
Model-based estimate of apparent clearance (CL/F) was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent clearance population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
| Liters / day | All Participants With PK Data |
|---|---|
| Apparent Clearance (CL/F) of Ligelizumab Estimated With a PopPK Model | 0.66 (0.44 to 1.03) |
Model-based estimate of apparent volume of distribution was derived using compartmental pharmacokinetic population (PopPK) modelling using non-linear mixed effects model for ligelizumab. Apparent volume of distribution population estimate was derived through fitting individual drug administration history and collected ligelizumab concentrations at the specified data points (listed in Time Frame).
| Liters | All Participants With PK Data |
|---|---|
| Apparent Volume of Distribution of Ligelizumab Estimated With a PopPK Model | 14.5 (11.02 to 16.65) |
Number of participants with AEs and SAEs, including significant changes from baseline in vital signs (blood pressure, pulse rate), electrocardiograms and laboratory values qualifying and reported as AEs. The number of participants in each category is reported in the table.
| Participants | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg |
|---|---|---|---|
| AEs | 18 | 11 | 9 |
| Treatment related AEs | 6 | 5 | 2 |
| SAEs | 1 | 0 | 1 |
| SAEs leading to treatment discontinuation | 0 | 0 | 1 |
Collected over Adverse events were reported from the start treatment to 20 weeks after end of treatment, assessed up to maximum duration of 40 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ligelizumab 24 mg | 0/24 (0%) | 1/24 (4.2%) | 18/24 (75%) |
| Ligelizumab 120 mg | 0/13 (0%) | 0/13 (0%) | 11/13 (84.6%) |
| Placebo + Ligelizumab 120 mg | 0/12 (0%) | 1/12 (8.3%) | 9/12 (75%) |
| Total | 0/49 (0%) | 2/49 (4.1%) | 38/49 (77.6%) |
| Event | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg | Total |
|---|---|---|---|---|
| Pulmonary valve incompetenceCardiac disorders | 0/24 | 0/13 | 1/12 | 1/49 |
| Tricuspid valve incompetenceCardiac disorders | 0/24 | 0/13 | 1/12 | 1/49 |
| Suicide attemptPsychiatric disorders | 1/24 | 0/13 | 0/12 | 1/49 |
| Event | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg | Total |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 7/24 | 4/13 | 4/12 | 15/49 |
| HeadacheNervous system disorders | 5/24 | 1/13 | 4/12 | 10/49 |
| NauseaGastrointestinal disorders | 1/24 | 3/13 | 1/12 | 5/49 |
| VomitingGastrointestinal disorders | 1/24 | 3/13 | 0/12 | 4/49 |
| Chronic spontaneous urticariaSkin and subcutaneous tissue disorders | 5/24 | 0/13 | 0/12 | 5/49 |
| DiarrhoeaGastrointestinal disorders | 2/24 | 0/13 | 2/12 | 4/49 |
| InfluenzaInfections and infestations | 2/24 | 1/13 | 2/12 | 5/49 |
| PyrexiaGeneral disorders and administration site conditions | 2/24 | 2/13 | 0/12 | 4/49 |
| RhinitisInfections and infestations | 0/24 | 2/13 | 0/12 | 2/49 |
| Upper respiratory tract infectionInfections and infestations | 3/24 | 2/13 | 0/12 | 5/49 |
| Age, Continuous(Years) | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg | Total |
|---|---|---|---|---|
| Mean | 14.9 ± 1.94 | 15.2 ± 1.41 | 14.4 ± 1.51 | 14.8 ± 1.70 |
| Sex: Female, Male(Participants) | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg | Total |
|---|---|---|---|---|
| Female | 10 | 9 | 9 | 28 |
| Male | 14 | 4 | 3 | 21 |
| Race (NIH/OMB)(Participants) | Ligelizumab 24 mg | Ligelizumab 120 mg | Placebo + Ligelizumab 120 mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 7 | 1 | 2 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 16 | 12 | 10 | 38 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Ran from Aug 2018 to primary completion in Oct 2020, 26 months.
Results were first posted in Aug 2021, 10 months after primary completion.
Of 31 phase 2 interventional studies under Chronic Urticaria, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's 26 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions 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.
Studies of the drug tested here: Ligelizumab