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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005339-56 | EudraCT Number | ||
| EMEA-001811-PIP03-20 | Other Identifier | EMA paediatric investigation plan number |
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Study terminated by sponsor
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This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.
Participants were randomized to ligelizumab 240 mg, ligelizumab 120 mg, or placebo (5 treatment arms, randomization ratio of 2:2:2:2:1) for the double-blind placebo-controlled treatment period (up to Week 12).
Participants initially assigned to the 8-week placebo arms received the first dose of blinded ligelizumab treatment at the Week 8 visit. Participants initially assigned to the 16-week placebo arm received the last dose of placebo before the Double Blind Placebo Controlled Food Challenge (DBPCFC) at Week 12 and the first dose of blinded ligelizumab treatment at the Week 16 visit.
At the start of the study, recruitment was restricted to 12-55-year-old participants. After approximately 60 adolescent participants (defined as 12-17 yrs of age) had completed all Week 12 assessments, an interim analysis (IA1) on Pharmacokinetics (PK) and selected Pharmacodynamics (PD) data (total IgE and basophil bound High affinity immunoglobulin E receptor 1 (FcƐRI)) was performed (safety was reviewed by a Data Monitoring Committee - DMC). Independent sponsor members who were responsible for PK/ PD data analysis and Modeling & Simulation were unblinded to the results of this interim analysis. The planned intent of this analysis was to confirm the dosing strategy for the youngest age group, 6-11 yrs and once the dose was to be confirmed, recruitment was supposed to be open for this age group. However, Novartis made a strategic decision to close recruitment in the study CQGE031G12301 and to terminate the study early, once all eligible participants in the study had completed week 12 assessments and the 16-week safety follow-up period. This decision was based on a blinded data review, which showed evidence of efficacy without the detection of any safety signal and that efficacy may be optimized with a different dosing regimen. Due to this decision, the final population size was 211, with only adolescent and adult participants (12 - 17yrs, and 18 - 55yrs) recruited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ligelizumab 240 mg | Experimental | ligelizumab 240 mg subcutaneous injection for 52 weeks |
|
| ligelizumab 120 mg | Experimental | ligelizumab 120 mg subcutaneous injection for 52 weeks |
|
| Placebo 8 weeks and ligelizumab 120 mg | Experimental | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
|
| Placebo 16 weeks and ligelizumab 120 mg/240 mg | Experimental | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
| Placebo 8 weeks and ligelizumab 240 mg | Experimental | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ligelizumab | Drug | Subcutaneous injection once every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
History of hypersensitivity to ligelizumab or its excipients, or to other biologics (i.e., to murine, chimeric or human antibodies).
Hypersensitivity or intolerance to any of the matrix components used within the material for the oral food challenge.
History of severe or life-threatening hypersensitivity event needing an ICU (intensive care unit) admission or intubation within 60 days prior to baseline DBPCFC (Screening Visit 2).
Total IgE >2000 IU/mL at Screening Visit 1.
Participants with uncontrolled asthma (according to Global Initiative for Asthma (GINA) guidelines, GINA 2020) who meet any of the following criteria:
Current or previous history of a mast cell disorder, including mastocytosis.
Platelets < 100'000/μL at Screening Visit 1.
Female participants not on oral contraception with a stable dose for a minimum of 3 months prior to taking study treatment.
Participants with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines at Screening Visit 1 (before start of Screening Visit 2). If stool testing is positive for pathogenic organisms, the participant should not be randomized and should not be allowed to be rescreened.
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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 |
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| 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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This study was conducted in 56 centers in 10 countries worldwide
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| ID | Title | Description |
|---|---|---|
| FG000 | Ligelizumab 240 mg | ligelizumab 240 mg subcutaneous injection for 52 weeks |
| FG001 | Ligelizumab 120 mg | ligelizumab 120 mg subcutaneous injection for 52 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 | Apr 12, 2022 | May 22, 2024 |
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| Placebo | Drug | Subcutaneous injection once every 4 weeks |
|
| Week 12 |
| Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Week 12 |
| Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Symptom severity occurring at any challenge dose of peanut protein up to and including 1000 mg during the DBPCFC conducted at Week 12 was categorized as 4 levels: None, Mild, Moderate, Severe. The CoFAR grading system was used to categorize the symptom severity as mild, moderate and severe. Symptom severity for participants who completed DBPCFC without any symptom were categorized as none. | Week 12 |
| Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 After 4 Weeks of Treatment | Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12 after 4 weeks of treatment (8 weeks of placebo + 4 weeks of ligelizumab treatment versus 12 weeks of placebo). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Week 12 |
| Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | Responder rate was defined as the percentage of participants tolerating the specified peanut protein doses (>= 600 mg (1044 mg cumulative tolerated dose), >= 1000 mg (2044 mg cumulative tolerated dose) or 3000 mg (5044 mg cumulative tolerated dose)) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 52. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. | Week 52 |
| Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. | Baseline, Week 12, Week 52 |
| Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE) | Baseline, Week 12, Week 52 |
| Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4) | Baseline, Week 12, Week 52 |
| Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | The Skin Prick Test (SPT) is a widely used diagnostic tool for identifying allergen-specific IgE-mediated allergies. During the test, a small amount of allergen, in this case, peanut allergen, is introduced into the skin. The allergen interacts with specific IgE antibodies bound to cutaneous mast cells. This interaction can cause a reaction, resulting in a wheal and flare on the skin. The size of the wheal and flare, specifically the longest diameter and the midpoint orthogonal diameter, were evaluated at each site and the average size of the wheal and flare across all sites was summarized and reported. Considering the study termination, SPT originally scheduled at Week 56 was performed 4 weeks after Week 12 assessment in some patients. | Baseline, Week 16/Week 56 |
| Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | The Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR) and Risk of Accidental Exposure (RAE)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
| Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | The Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR), Risk of Accidental Exposure (RAE) and Food Allergy Related Health (FAH)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | The Food Allergy Independent Measure (FAIM) - Teenager Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is not calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | The Food Allergy Independent Measure (FAIM) - Adult Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
| Change From Baseline in the 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 is designed for use in surveys of general and specific populations, health policy evaluations and clinical practice and research. It contains 8 scales and 2 component summary indices evaluating physical, social and emotional functioning in addition to general health perceptions and mental health. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) and mental component summary (MCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS and MCS scores range 0 to 100). | Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
| 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 Clinical Research 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 |
| Colorado Allergy and Asthma Ctr PC | Denver | Colorado | 80230 | 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 Childrens Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Family Allergy and Asthma | Louisville | Kentucky | 40217 | United States |
| Johns Hopkins Childrens Center | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | 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 |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas 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 | Odense | 5000 | Denmark |
| Novartis Investigative Site | Angers | 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 | Berlin | 13353 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | 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 | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Novartis Investigative Site | Utrecht | 3584CX | Netherlands |
| Novartis Investigative Site | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| FG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| FG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| FG004 | Placebo 16 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks |
| FG005 | Placebo 16 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks |
| Randomized Analysis Set (RAS) | All randomized participants, regardless of whether or not they receive a dose of study drug |
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| Full Analysis Set (FAS) | All participants who received at least one dose of study treatment. Mis-randomized patients (mis-randomized in IRT) will be excluded from FAS |
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| Safety Set (SAF) | All participants who received at least one dose of study treatment whether or not being randomized |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ligelizumab 240 mg | ligelizumab 240 mg subcutaneous injection for 52 weeks |
| BG001 | Ligelizumab 120 mg | ligelizumab 120 mg subcutaneous injection for 52 weeks |
| BG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| BG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| BG004 | Placebo 16 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks |
| BG005 | Placebo 16 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks |
| BG006 | 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 |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Time to diagnosis of peanut allergy | Mean | Standard Deviation | Years |
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| Number of participants with at least one food allergy | Count of Participants | Participants |
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| Peanut specific Immunoglobulin E (IgE) | Mean | Standard Deviation | IU/mL |
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| Total Immunoglobulin E (IgE) | Mean | Standard Deviation | IU/mL |
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| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) | Count of Participants | Participants |
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| Peanut Skin Prick Test (SPT) (undiluted): Size of mean wheal diameter | Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters | Participants for which baseline data are not available are not counted. | Mean | Standard Deviation | mm |
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| Peanut Skin Prick Test (SPT) (average across dilutions): Size of mean wheal diameter | Size of Mean wheal diameter (mm) = [(Mean of peanut wheal longest diameter + Mean of peanut wheal orthogonal diameter)/2]- average of the non-missing negative control diameters. Range of dilutions (1:10 to 1:100,000). | Participants for which baseline data are not available are not counted. | Mean | Standard Deviation | mm |
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| Poly-sensitized to food | Poly-sensitization is defined as specific Immunoglobulin E (sIgE) >=0.35kUA/L for a food allergen in the panel other than peanut. | Count of Participants | Participants |
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| Poly-allergic to food | Poly-allergic: Participants experiencing more than one food allergies in medical history. | Count of Participants | Participants |
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| History of anaphylactic reaction to food | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 | Responder rate was defined as the percentage of participants tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Symptom severity occurring at any challenge dose of peanut protein up to and including 1000 mg during the DBPCFC conducted at Week 12 was categorized as 4 levels: None, Mild, Moderate, Severe. The CoFAR grading system was used to categorize the symptom severity as mild, moderate and severe. Symptom severity for participants who completed DBPCFC without any symptom were categorized as none. | Full Analysis Set (FAS). This outcome measure applies to ligelizumab 120 mg arm, ligelizumab 240 mg arm, and placebo 16-week to ligelizumab 120/240 mg arm (labelled as placebo for efficacy estimands). | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 After 4 Weeks of Treatment | Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12 after 4 weeks of treatment (8 weeks of placebo + 4 weeks of ligelizumab treatment versus 12 weeks of placebo). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | Responder rate was defined as the percentage of participants tolerating the specified peanut protein doses (>= 600 mg (1044 mg cumulative tolerated dose), >= 1000 mg (2044 mg cumulative tolerated dose) or 3000 mg (5044 mg cumulative tolerated dose)) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 52. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. Week 52 includes participants who actually reached Week 52 and who reached any week between Week 12 and Week 52 as the end of treatment visit due to study early termination. | Posted | Count of Participants | Participants | Week 52 |
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| Secondary | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Change from baseline in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 12 and Week 52. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Baseline, Week 12, Week 52 |
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| Secondary | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE) | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | Posted | Mean | Standard Deviation | kilounits per liter (kU/L) | Baseline, Week 12, Week 52 |
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| Secondary | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4) | Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included. | Posted | Mean | Standard Deviation | mg/L | Baseline, Week 12, Week 52 |
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| Secondary | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | The Skin Prick Test (SPT) is a widely used diagnostic tool for identifying allergen-specific IgE-mediated allergies. During the test, a small amount of allergen, in this case, peanut allergen, is introduced into the skin. The allergen interacts with specific IgE antibodies bound to cutaneous mast cells. This interaction can cause a reaction, resulting in a wheal and flare on the skin. The size of the wheal and flare, specifically the longest diameter and the midpoint orthogonal diameter, were evaluated at each site and the average size of the wheal and flare across all sites was summarized and reported. Considering the study termination, SPT originally scheduled at Week 56 was performed 4 weeks after Week 12 assessment in some patients. | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | undiluted peanut protein (mm) | Baseline, Week 16/Week 56 |
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| Secondary | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | The Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR) and Risk of Accidental Exposure (RAE)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. | Full Analysis Set. Only adolescent participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
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| Secondary | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | The Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (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 (EI), Allergen Avoidance and Dietary Restrictions (AADR), Risk of Accidental Exposure (RAE) and Food Allergy Related Health (FAH)). Each item is scored on a 7-point scale (coded as 1-7 in analysis), with a higher score indicating greater impairment in HRQoL. The total score and the domain scores are calculated as the arithmetic average of all completed items. If more than one item in any domain is missing, a domain score should not be calculated for that case. However, a total score could still be calculated if 20% or fewer of the items are missing. Therefore, the range for each item, domain, and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. | Full Analysis Set. Only adult participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
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| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | The Food Allergy Independent Measure (FAIM) - Teenager Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is not calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. | Full Analysis Set. Only adolescent participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
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| Secondary | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | The Food Allergy Independent Measure (FAIM) - Adult Form (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. Each question is scored on a 7-point scale (coded as 1-7 in analysis), with a greater score indicating a higher level of perceived risk or chance of adverse events occurring. The total score is calculated as the arithmetic average of all completed items. If less than 80% of the items within the score are complete, the total score is calculated. Therefore, the range for each item and the total score is from 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. | Full Analysis Set. Only adult participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 12 Part 1 (10 Days Before Day 1 Oral Food Challenge (OFC)), Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
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| Secondary | Change From Baseline in the 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 is designed for use in surveys of general and specific populations, health policy evaluations and clinical practice and research. It contains 8 scales and 2 component summary indices evaluating physical, social and emotional functioning in addition to general health perceptions and mental health. Responses to items allow for direct calculation of scale scores, while the physical component summary (PCS) and mental component summary (MCS) scores are computed from weighted scale scores. For all scales and summary measures, higher scores indicate better health outcomes (PCS and MCS scores range 0 to 100). | Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) |
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Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication, up to approximately 22 months.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up.
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 | Placebo Controlled Period (Up to Week 8) Ligelizumab 240 mg SCq4w | Placebo controlled period (Up to Week 8) Ligelizumab 240 mg SCq4w | 0 | 47 | 0 | 47 | 21 | 47 |
| EG001 | Placebo Controlled Period (Up to Week 8) Ligelizumab 120 mg SCq4w | Placebo controlled period (Up to Week 8) Ligelizumab 120 mg SCq4w | 0 | 51 | 0 | 51 | 17 | 51 |
| EG002 | Placebo Controlled Period (Up to Week 8): Placebo | Up to Week 8 (before transition to active treatment) for participants randomized to either the 8-week or 16-week Placebo arm | 0 | 113 | 0 | 113 | 27 | 113 |
| EG003 | Placebo Controlled Period (Up to Week 16) Ligelizumab 240 mg SCq4w | Only participants randomized to Ligelizumab 240 mg subcutaneous (SC) every 4 weeks (q4w) without placebo | 0 | 47 | 0 | 47 | 26 | 47 |
| EG004 | Placebo Controlled Period (Up to Week 16) Ligelizumab 120 mg SCq4w | Only participants randomized to Ligelizumab 120 mg subcutaneous (SC) every 4 weeks (q4w) without placebo | 0 | 51 | 0 | 51 | 20 | 51 |
| EG005 | Placebo Controlled Period (Up to Week 16): Placebo | Up to Week 16 (before transition to active treatment) for participants randomized to the 16-week Placebo arm only | 0 | 23 | 0 | 23 | 9 | 23 |
| EG006 | Any Ligelizumab 240 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | Participants randomized to Ligelizumab 240 mg subcutaneous (SC) every 4 weeks (q4w), either with or without Placebo and who took at least one dose of active treatment during the entire study period | 0 | 99 | 0 | 99 | 57 | 99 |
| EG007 | Any Ligelizumab 120 mg SCq4w (Subcutaneous Injection Every 4 Weeks) - Up to Week 68 | Participants randomized to Ligelizumab 120 mg subcutaneous (SC) every 4 weeks (q4w), either with or without Placebo and who took at least one dose of active treatment during the entire study period | 0 | 101 | 1 | 101 | 53 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Injection site oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (26.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (26.1) | 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 the pooled data (i.e., data from all sites) in the clinical trial.
| 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 | Sep 11, 2023 | May 22, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598891 | ligelizumab |
Not provided
Not provided
Not provided
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| Regression, Logistic |
| 0.073 |
| Odds Ratio (OR) |
| 5.10 |
| 2-Sided |
| 95 |
| 0.80 |
| 100.98 |
logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates. |
| Other |
ligelizumab 120 mg subcutaneous injection for 52 weeks
| OG002 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
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ligelizumab 120 mg subcutaneous injection for 52 weeks
| OG002 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
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| Units | Counts |
|---|---|
| Participants |
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| Placebo |
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
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| OG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
| Placebo 8 Weeks and Ligelizumab 120 mg |
Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
| OG004 |
| Placebo |
Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
|
ligelizumab 120 mg subcutaneous injection for 52 weeks |
| OG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
|
ligelizumab 120 mg subcutaneous injection for 52 weeks |
| OG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
|
ligelizumab 120 mg subcutaneous injection for 52 weeks |
| OG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
|
ligelizumab 120 mg subcutaneous injection for 52 weeks |
| OG002 | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
|
|
|
Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks |
| OG003 | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks |
| OG004 | Placebo | Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks |
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