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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502366-25-00 | Registry Identifier | EU CTIS |
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Sponsor decision
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This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.
Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.
A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ligelizumab 120 mg | Experimental | Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. |
|
| Ligelizumab 240 mg | Experimental | Participants received ligelizumab 240 mg every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligelizumab 120 mg | Drug | 1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. | Up to approximately 81 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms | Assessed during an open-label oral food challenge (OFC). If missing Week 52-OFC assessments, Week 156-OFC assessments were performed within 380 days (inclusive) after first extension dose date and considered as Week 52-OFC assessments. | Up to approximately 97 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allervie Clinical Research | Birmingham | Alabama | 35209 | United States | ||
| Allergy and Immunology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38814736 | Derived | Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
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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
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164 participants were screened in this study, of which one was a screen failure; 163 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ligelizumab 120 mg | Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. |
| FG001 | Ligelizumab 240 mg | Participants received ligelizumab 240 mg every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 14, 2023 | Aug 28, 2025 |
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| Ligelizumab 240 mg | Drug | 2 injections of 1.0 mL ligelizumab every 4 weeks |
|
| Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. | Up to approximately 81 weeks |
| Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | The FAQLQ-TF is a self-reported instrument designed for adolescents aged 13-17 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes three domains (emotional impact, allergen avoidance and dietary restrictions, and risk of accidental exposure). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. | Up to approximately 97 weeks |
| Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | The FAQLQ-AF is a self-reported instrument designed for adults aged 18-55 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes four domains (emotional impact, allergen avoidance and dietary restrictions, risk of accidental exposure, and food allergy-related health). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. | Up to approximately 97 weeks |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF) | The FAIM-TF is a self-reported instrument designed for adolescents aged 13-17. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions. The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. | Up to approximately 97 weeks |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF) | The FAIM-AF is a self-reported instrument designed for adults aged 18-55. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. the range for each item and the total score is from 1 (minimum) to 7 (maximum). The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. | Up to approximately 97 weeks |
| Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) | The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It contains 8 scales and 2 component summary indices evaluating physical, social, and emotional functioning in addition to general health perceptions and mental health. PCS and MCS scores range from 0 to 100, with higher scores indicating better health outcomes. | Up to approximately 97 weeks |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
| Allergy and Asthma Associates of Santa Clara Vally Center | San Jose | California | 95117 | United States |
| Allergy and Asthma Clin Res Inc | Walnut Creek | California | 94598 | United States |
| UCHealth Outpatient Pavilion | Aurora | Colorado | 80045 | United States |
| Asthma and Allergy Associates P C | Colorado Springs | Colorado | 80907 | United States |
| Univ of South Florida Asthma Allergy and Immunology CRU | Tampa | Florida | 33613 | United States |
| Childrens Healthcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Atlanta Allergy and Asthma Clinic | Marietta | Georgia | 30062 | United States |
| Ann and Robert H Lurie Childs Hosp | Chicago | Illinois | 60611 | United States |
| Family Allergy and Asthma | Lousiville | Kentucky | 40217 | United States |
| Johns Hopkins Childrens Center | Baltimore | Maryland | 21287 | United States |
| Boston Childrens Hospital | Boston | Massachusetts | 02215 | United States |
| University of Michigan Clinical Trials Office | Ann Arbor | Michigan | 48109 | United States |
| Respiratory Medicine Research Institute of Michigan | Ypsilanti | Michigan | 48197 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| Northwell Health | New York | New York | 10028 | United States |
| Mt Sinai Medical Center | New York | New York | 10029-6574 | United States |
| University Of NC At Chapel Hill | Chapel Hill | North Carolina | 27599 9500 | United States |
| Cincinnati Childrens Hospital MC | Cincinnati | Ohio | 45229-3039 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Unv of TX Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Texas Childrens Hospital | Houston | Texas | 77030 | United States |
| Seattle Allergy and Asthma Rsch | Seattle | Washington | 98115 | United States |
| Novartis Investigative Site | Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3052 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M3B 3S6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1C5 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1V 4W2 | Canada |
| Novartis Investigative Site | Angers | France | 49933 | France |
| Novartis Investigative Site | Lille | 59000 | France |
| Novartis Investigative Site | Toulouse | 31400 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Novartis Investigative Site | Frankfurt am Main | Hesse | 60596 | Germany |
| Novartis Investigative Site | Dresden | Saxony | 01307 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Sagamihara | Kanagawa | 252-0392 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Novartis Investigative Site | Utrecht | 3584 CX | Netherlands |
| Novartis Investigative Site | Esplugues | Barcelona | 08950 | Spain |
| Novartis Investigative Site | Barcelona | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| A Pediatric Plain Language Trial Summary is available on www.novctrd.com | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ligelizumab 120 mg | Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. |
| BG001 | Ligelizumab 240 mg | Participants received ligelizumab 240 mg every 4 weeks. |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. | Safety Set 1 included all participants who received at least one dose of study treatment during the extension study. | Posted | Number | percentage of participants | Up to approximately 81 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms | Assessed during an open-label oral food challenge (OFC). If missing Week 52-OFC assessments, Week 156-OFC assessments were performed within 380 days (inclusive) after first extension dose date and considered as Week 52-OFC assessments. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Data are reported for participants who responded and had an evaluable value. | Posted | Count of Participants | Participants | Up to approximately 97 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug | TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment. | Safety Set 1 included all participants who received at least one dose of study treatment during the extension study. Number analyzed is the number of participants with available data. | Posted | Number | percentage of participants | Up to approximately 81 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | The FAQLQ-TF is a self-reported instrument designed for adolescents aged 13-17 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes three domains (emotional impact, allergen avoidance and dietary restrictions, and risk of accidental exposure). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Posted | Mean | Standard Deviation | Unit on a scale | Up to approximately 97 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | The FAQLQ-AF is a self-reported instrument designed for adults aged 18-55 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes four domains (emotional impact, allergen avoidance and dietary restrictions, risk of accidental exposure, and food allergy-related health). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Posted | Mean | Standard Deviation | Unit on a scale | Up to approximately 97 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF) | The FAIM-TF is a self-reported instrument designed for adolescents aged 13-17. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions. The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Posted | Mean | Standard Deviation | Unit on a scale | Up to approximately 97 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF) | The FAIM-AF is a self-reported instrument designed for adults aged 18-55. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. the range for each item and the total score is from 1 (minimum) to 7 (maximum). The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Posted | Mean | Standard Deviation | Unit on a scale | Up to approximately 97 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) | The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It contains 8 scales and 2 component summary indices evaluating physical, social, and emotional functioning in addition to general health perceptions and mental health. PCS and MCS scores range from 0 to 100, with higher scores indicating better health outcomes. | The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included. | Posted | Mean | Standard Deviation | Unit on a scale | Up to approximately 97 weeks |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ligelizumab 120 mg | Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks. | 0 | 81 | 3 | 81 | 47 | 81 |
| EG001 | Ligelizumab 240 mg | Participants received ligelizumab 240 mg every 4 weeks. | 0 | 82 | 2 | 82 | 43 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomyopathy | Cardiac disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Swelling face | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site induration | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site oedema | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders and administration site conditions | MedDRA (27.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (27.1) | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2025 | Aug 28, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000074924 | Nut and Peanut Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598891 | ligelizumab |
Not provided
Not provided
Not provided
| 18 - 55 years |
|
| Male |
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| Black or African American |
|
| Asian |
|
| Multiple |
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| Not Reported |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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