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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003018-11 | EudraCT Number |
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Phase III PEARL studies (CQGE031C2302 and CQGE031C2303) with ligelizumab met their primary endpoint of superiority vs placebo at Week 12 for treatment of CSU, but not versus omalizumab. Decision to discontinue was not based on safety concerns.
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This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines
There are currently no approved therapies for patients with CINDU who remain symptomatic despite treatment with H1-antihistamines. The purpose of this study was to establish efficacy and safety of ligelizumab (QGE031) over placebo in participants with chronic inducible urticaria (CINDU) who remain symptomatic despite treatment with H1 antihistamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligelizumab low dose, symptomatic dermographism group | Experimental | Ligelizumab low dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism |
|
| Ligelizumab high dose, symptomatic dermographism | Experimental | Ligelizumab high dose subcutaneous injection every 4 weeks in participants with symptomatic dermographism |
|
| Placebo SC q4W, symptomatic dermographism | Placebo Comparator | Placebo subcutaneous injection every 4 weeks in participants with symptomatic dermographism |
|
| Ligelizumab low dose, cold urticaria | Experimental | Ligelizumab low dose subcutaneous injection every 4 weeks in participants with cold urticaria |
|
| Ligelizumab high dose, cold urticaria | Experimental | Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cold urticaria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligelizumab | Drug | Ligelizumab treated groups and arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism | Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed | Baseline, Week 12 |
| Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria | The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms. | Baseline, Week 12 |
| Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0 | Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 | Week 12 |
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Inclusion Criteria:
Confirmed CINDU diagnosis (as per guidelines) for symptomatic dermographism, cold urticaria or cholinergic urticaria for ≥ 4 months.
Exclusion Criteria:
History of hypersensitivity to any of the study drugs or its components or to drugs of similar chemical classes or to the provocation test or items used in provocation tests
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Evansville | Indiana | 47713 | United States | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Patient Lay Trial Summary | View source |
Not provided
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
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There were no pre-assignment details for this study.
39 participants were randomized. None completed study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 72 mg Ligelizumab, Symptomatic Dermographism | 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism |
| FG001 | 120 mg Ligelizumab, Symptomatic Dermographism |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2021 | Feb 9, 2023 |
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| Placebo SC q4w, cold urticaria |
| Placebo Comparator |
Placebo subcutaneous injection every 4 weeks in participants with cold urticaria |
|
| Ligelizumab high dose, cholinergic urticaria | Experimental | Ligelizumab high dose subcutaneous injections every 4 weeks in participants with cholinergic urticaria |
|
| Placebo SC q4w, cholinergic urticaria | Placebo Comparator | Placebo subcutaneous injections every 4 weeks in participants with cholinergic urticaria |
|
|
| Placebo | Other | Placebo treated groups and arms |
|
| Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | Baseline, Week 12 |
| Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest | The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms. | Baseline, Week 12 |
| Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | Baseline, Week 12 |
| Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0 | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | Week 12 |
| Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0 | Physician global assessment of severity of hives PGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives) | Week 12 |
| North Charleston |
| South Carolina |
| 29420 |
| United States |
| Novartis Investigative Site | El Paso | Texas | 79903 | United States |
| Novartis Investigative Site | Murray | Utah | 84107 | United States |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3002 | Australia |
| Novartis Investigative Site | Athens | 12462 | Greece |
| Novartis Investigative Site | Debrecen | Hajdú-Bihar | 4026 | Hungary |
| Novartis Investigative Site | Pécs | 7632 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Izhevsk | 426061 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194156 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194354 | Russia |
| Novartis Investigative Site | Saint Petersburg | 198260 | Russia |
| Novartis Investigative Site | Stavropol | 355000 | Russia |
| Novartis Investigative Site | Kežmarok | 060 01 | Slovakia |
| Novartis Investigative Site | SvidnÃk | 08901 | Slovakia |
| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34093 | Turkey (Türkiye) |
120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism
| FG002 | Placebo - 72 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
| FG003 | Placebo - 120 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
| FG004 | 72 mg Ligelizumab Cold Urticaria | 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria |
| FG005 | 120 mg Ligelizumab, Cold Urticaria | 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria |
| FG006 | Placebo - 72 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria |
| FG007 | Placebo - 120 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria |
| FG008 | 120 mg Ligelizumab, Cholinergic Urticaria | 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria |
| FG009 | Placebo - 120 mg Ligelizumab, Cholinergic Urticaria | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up |
|
|
The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of study drug. Participants were analyzed according to the treatment they were assigned. Data could not be analyzed because no subject completed Week 12 in the sympomatic dermographism cohort, 1 subject each completed the Week 12 in 72 mg ligelizumab and 120 mg ligelizumab groups in cold urticaria cohort, 1 subject completed Week 12 in cholinergic urticaria cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | 72 mg Ligelizumab, Symptomatic Dermographism | 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism |
| BG001 | 120 mg Ligelizumab, Symptomatic Dermographism | 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism |
| BG002 | Placebo - 72 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
| BG003 | Placebo - 120 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
| BG004 | 72 mg Ligelizumab Cold Urticaria | 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria |
| BG005 | 120 mg Ligelizumab, Cold Urticaria | 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria |
| BG006 | Placebo - 72 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria |
| BG007 | Placebo - 120 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria |
| BG008 | 120 mg Ligelizumab, Cholinergic Urticaria | 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria |
| BG009 | Placebo - 120 mg Ligelizumab, Cholinergic Urticaria | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Fric Score in Participants With Symptomatic Dermographism | Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed | The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Baseline, Week 12 |
|
| ||||||||||||||||||||||||||||
| Primary | Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria | The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms. | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Temperature (degrees celcius) | Baseline, Week 12 |
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Scores on a scale | Baseline, Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Symptomatic Dermographism With Total Fric Score = 0 | Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Week 12 |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Itch Numerical Rating Scale in Participants With Symptomatic Dermographism | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. No participants completed week 12. | Posted | Baseline, Week 12 |
| |||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest | The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms. | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Proportion of participants | Baseline, Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Scores on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0 | Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement. Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch") | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Proportion of participants | Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0 | Physician global assessment of severity of hives PGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives) | RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints. | Posted | Number | Proportion of participants | Week 12 |
|
|
Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment).
AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ligelizumab 72mg | 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism | 0 | 8 | 0 | 8 | 3 | 8 |
| EG001 | Ligelizumab 120mg | symptomatic dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic | 0 | 15 | 0 | 15 | 6 | 15 |
| EG002 | Placebo - Ligelizumab 72mg | symptomatic dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism | 0 | 5 | 0 | 5 | 3 | 5 |
| EG003 | Placebo - Ligelizumab 120mg | symptomatic dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism | 0 | 11 | 0 | 11 | 1 | 11 |
| EG004 | Total | Total number of participants who participated in the trial | 0 | 39 | 0 | 39 | 13 | 39 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | (862) 778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2022 | Feb 9, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000094482 | Chronic Inducible Urticaria |
| C536612 | Familial dermographism |
| D000096703 | Cold Urticaria |
| D014581 | Urticaria |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598891 | ligelizumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| OG003 | Placebo - 120 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria |
|
|
| Participants |
|
|
| OG003 | Placebo - 120 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
|
| OG003 | Placebo - 120 mg Ligelizumab, Symptomatic Dermographism | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism |
|
| OG003 | Placebo - 120 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria |
|
|
| OG003 | Placebo -120 mg Ligelizumab, Cold Urticaria | Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria |
|
|
| Participants |
|
|
|
|