Allergy, Peanut
Conditions
Keywords
Food allergy, Peanut allergy, Oral food challenge, IgE, ligelizumab
Brief summary
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.
Detailed description
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.
Interventions
DRUGligelizumab
Subcutaneous injection once every 4 weeks
DRUGPlacebo
Subcutaneous injection once every 4 weeks
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Signed informed consent and/or assent (where applicable) was obtained prior to study participation. Participant (and parent/legal guardian) was able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she was re-consented (ICF) at the next study visit. 2. Male or female participants who were 6 to 55 yrs of age at the time of signing informed consent/assent. 3. Documented medical history of allergy to peanuts or peanut-containing foods. 4. Positive peanut-specific IgE (peanut sIgE), ≥ 0.35 kUA/L at Screening Visit 1. 5. Positive SPT for peanut allergen at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control. 6. A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires presence of all inclusion and absence of all
Exclusion criteria
. 7. Participants must weigh ≥ 20 kg at Screening Visit 1. 8. Participants must be able to receive injections (study treatment), participate in the DBPCFC, and must be willing to continue avoiding exposure to peanuts and any other foods that they are allergic to throughout this study. Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4) |
| Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | 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. |
| 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 | 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 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. |
| Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | 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. |
| Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Baseline, Week 12, 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. |
| 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 | 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. |
| Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | Baseline, 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. |
| Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | 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)) | 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. |
| Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | 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)) | 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. |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | 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)) | 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. |
| Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | 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)) | 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. |
| Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC)) | 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). |
| Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Baseline, Week 12, Week 52 | Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE) |
Countries
Australia, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United States
Participant flow
Recruitment details
This study was conducted in 56 centers in 10 countries worldwide
Participants by arm
| Arm | Count |
|---|---|
| Ligelizumab 240 mg ligelizumab 240 mg subcutaneous injection for 52 weeks | 47 |
| Ligelizumab 120 mg ligelizumab 120 mg subcutaneous injection for 52 weeks | 51 |
| Placebo 8 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks | 46 |
| Placebo 8 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks | 44 |
| Placebo 16 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks | 11 |
| Placebo 16 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks | 12 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Guardian decision | 0 | 1 | 0 | 2 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Subject decision | 2 | 10 | 3 | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Ligelizumab 240 mg | Ligelizumab 120 mg | Placebo 8 Weeks and Ligelizumab 240 mg | Placebo 8 Weeks and Ligelizumab 120 mg | Placebo 16 Weeks and Ligelizumab 240 mg | Placebo 16 Weeks and Ligelizumab 120 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 19.5 Years STANDARD_DEVIATION 7.5 | 18.8 Years STANDARD_DEVIATION 6.27 | 18.7 Years STANDARD_DEVIATION 6.95 | 20.0 Years STANDARD_DEVIATION 7.75 | 17.4 Years STANDARD_DEVIATION 4.57 | 16.1 Years STANDARD_DEVIATION 3.58 | 18.9 Years STANDARD_DEVIATION 6.85 |
| Age, Customized 12 - 17 years | 27 Participants | 29 Participants | 25 Participants | 24 Participants | 6 Participants | 8 Participants | 119 Participants |
| Age, Customized 18 - 55 years | 20 Participants | 22 Participants | 21 Participants | 20 Participants | 5 Participants | 4 Participants | 92 Participants |
| History of anaphylactic reaction to food No | 14 Participants | 15 Participants | 16 Participants | 12 Participants | 2 Participants | 4 Participants | 63 Participants |
| History of anaphylactic reaction to food Unknown | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| History of anaphylactic reaction to food Yes | 32 Participants | 36 Participants | 29 Participants | 32 Participants | 9 Participants | 8 Participants | 146 Participants |
| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 10 mg | 9 Participants | 14 Participants | 7 Participants | 11 Participants | 4 Participants | 5 Participants | 50 Participants |
| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) < 1 mg | 2 Participants | 5 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 12 Participants |
| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 1 mg | 4 Participants | 4 Participants | 6 Participants | 9 Participants | 1 Participants | 2 Participants | 26 Participants |
| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 30 mg | 18 Participants | 14 Participants | 20 Participants | 11 Participants | 4 Participants | 4 Participants | 71 Participants |
| MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 3 mg | 14 Participants | 14 Participants | 11 Participants | 11 Participants | 1 Participants | 1 Participants | 52 Participants |
| Number of participants with at least one food allergy 1 food allergy | 12 Participants | 15 Participants | 13 Participants | 11 Participants | 5 Participants | 3 Participants | 59 Participants |
| Number of participants with at least one food allergy 2 food allergies | 10 Participants | 5 Participants | 8 Participants | 4 Participants | 1 Participants | 1 Participants | 29 Participants |
| Number of participants with at least one food allergy 3 food allergies | 5 Participants | 5 Participants | 2 Participants | 5 Participants | 3 Participants | 1 Participants | 21 Participants |
| Number of participants with at least one food allergy 4 food allergies | 8 Participants | 7 Participants | 6 Participants | 4 Participants | 0 Participants | 1 Participants | 26 Participants |
| Number of participants with at least one food allergy > 5 food allergies | 12 Participants | 15 Participants | 13 Participants | 17 Participants | 1 Participants | 4 Participants | 62 Participants |
| Number of participants with at least one food allergy 5 food allergies | 0 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 2 Participants | 14 Participants |
| Peanut Skin Prick Test (SPT) (average across dilutions): Size of mean wheal diameter | 7.232 mm STANDARD_DEVIATION 2.8339 | 7.273 mm STANDARD_DEVIATION 2.7253 | 7.508 mm STANDARD_DEVIATION 2.7624 | 7.907 mm STANDARD_DEVIATION 2.8866 | 6.575 mm STANDARD_DEVIATION 2.3809 | 7.743 mm STANDARD_DEVIATION 2.3547 | 7.442 mm STANDARD_DEVIATION 2.7463 |
| Peanut Skin Prick Test (SPT) (undiluted): Size of mean wheal diameter | 13.83 mm STANDARD_DEVIATION 5.72 | 14.61 mm STANDARD_DEVIATION 6.007 | 13.23 mm STANDARD_DEVIATION 6.414 | 16.82 mm STANDARD_DEVIATION 8.262 | 14.45 mm STANDARD_DEVIATION 4.845 | 12.17 mm STANDARD_DEVIATION 3.664 | 14.45 mm STANDARD_DEVIATION 6.508 |
| Peanut specific Immunoglobulin E (IgE) | 109.021 IU/mL STANDARD_DEVIATION 147.9877 | 80.644 IU/mL STANDARD_DEVIATION 117.6312 | 131.948 IU/mL STANDARD_DEVIATION 189.7757 | 116.198 IU/mL STANDARD_DEVIATION 128.9151 | 51.606 IU/mL STANDARD_DEVIATION 48.6951 | 262.136 IU/mL STANDARD_DEVIATION 543.7764 | 114.372 IU/mL STANDARD_DEVIATION 191.3605 |
| Poly-allergic to food No | 12 Participants | 15 Participants | 13 Participants | 11 Participants | 5 Participants | 3 Participants | 59 Participants |
| Poly-allergic to food Yes | 35 Participants | 36 Participants | 33 Participants | 33 Participants | 6 Participants | 9 Participants | 152 Participants |
| Poly-sensitized to food No | 18 Participants | 24 Participants | 24 Participants | 17 Participants | 3 Participants | 4 Participants | 90 Participants |
| Poly-sensitized to food Yes | 29 Participants | 27 Participants | 22 Participants | 27 Participants | 8 Participants | 8 Participants | 121 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 10 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 31 Participants | 36 Participants | 42 Participants | 39 Participants | 7 Participants | 10 Participants | 165 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 19 Participants | 20 Participants | 3 Participants | 6 Participants | 98 Participants |
| Sex: Female, Male Male | 22 Participants | 26 Participants | 27 Participants | 24 Participants | 8 Participants | 6 Participants | 113 Participants |
| Time to diagnosis of peanut allergy | 16.287 Years STANDARD_DEVIATION 7.9393 | 16.381 Years STANDARD_DEVIATION 6.9248 | 15.556 Years STANDARD_DEVIATION 7.5799 | 17.748 Years STANDARD_DEVIATION 7.8969 | 15.598 Years STANDARD_DEVIATION 5.3525 | 14.971 Years STANDARD_DEVIATION 3.5291 | 16.344 Years STANDARD_DEVIATION 7.2808 |
| Total Immunoglobulin E (IgE) | 524.35 IU/mL STANDARD_DEVIATION 444.009 | 482.25 IU/mL STANDARD_DEVIATION 478.047 | 455.38 IU/mL STANDARD_DEVIATION 397.96 | 436.31 IU/mL STANDARD_DEVIATION 335.113 | 325.15 IU/mL STANDARD_DEVIATION 208.482 | 635.42 IU/mL STANDARD_DEVIATION 535.099 | 476.81 IU/mL STANDARD_DEVIATION 418.656 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 51 | 0 / 113 | 0 / 47 | 0 / 51 | 0 / 23 | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 21 / 47 | 17 / 51 | 27 / 113 | 26 / 47 | 20 / 51 | 9 / 23 | 57 / 99 | 53 / 101 |
| serious Total, serious adverse events | 0 / 47 | 0 / 51 | 0 / 113 | 0 / 47 | 0 / 51 | 0 / 23 | 0 / 99 | 1 / 101 |
Outcome results
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.
Time frame: Week 12
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligelizumab 240 mg | 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 | 21 Participants |
| Ligelizumab 120 mg | 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 | 8 Participants |
| Placebo | 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 | 1 Participants |
p-value: 0.00295% CI: [4.34, 506.78]Regression, Logistic
p-value: 0.07395% CI: [0.8, 100.98]Regression, Logistic
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.
Time frame: Baseline, Week 12, Week 52
Population: Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 12 | 274.05 mg | Geometric Coefficient of Variation 501.051 |
| Ligelizumab 240 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 52 | 800.41 mg | Geometric Coefficient of Variation 178.687 |
| Ligelizumab 120 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 52 | 164.23 mg | Geometric Coefficient of Variation 459916.375 |
| Ligelizumab 120 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 12 | 104.31 mg | Geometric Coefficient of Variation 794.248 |
| Placebo | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 52 | 89.55 mg | Geometric Coefficient of Variation 408.957 |
| Placebo | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 12 | 148.98 mg | Geometric Coefficient of Variation 754.171 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 52 | 146.48 mg | Geometric Coefficient of Variation 113.009 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 12 | 44.29 mg | Geometric Coefficient of Variation 768.803 |
| Placebo | Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52 | Week 12 | 46.62 mg | Geometric Coefficient of Variation 555.207 |
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)
Time frame: Baseline, Week 12, Week 52
Population: Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 12 | 258.28 kilounits per liter (kU/L) | Standard Deviation 282.477 |
| Ligelizumab 240 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 52 | 362.36 kilounits per liter (kU/L) | Standard Deviation 436.857 |
| Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 12 | 295.60 kilounits per liter (kU/L) | Standard Deviation 321.451 |
| Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 52 | 297.94 kilounits per liter (kU/L) | Standard Deviation 285.827 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 12 | 302.22 kilounits per liter (kU/L) | Standard Deviation 323.846 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 52 | 338.63 kilounits per liter (kU/L) | Standard Deviation 435.532 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 52 | 361.44 kilounits per liter (kU/L) | Standard Deviation 587.852 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 12 | 400.03 kilounits per liter (kU/L) | Standard Deviation 611.676 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 12 | -35.52 kilounits per liter (kU/L) | Standard Deviation 179.04 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52 | Week 52 | 174.75 kilounits per liter (kU/L) | Standard Deviation 433.889 |
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)
Time frame: Baseline, Week 12, Week 52
Population: Full Analysis Set. Only participants with a value at both Baseline and the corresponding post-baseline visit (Week 12 or Week 52) included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 52 | -0.01 mg/L | Standard Deviation 0.608 |
| Ligelizumab 240 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 12 | -0.09 mg/L | Standard Deviation 0.65 |
| Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 52 | 0.73 mg/L | Standard Deviation 3.103 |
| Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 12 | 0.35 mg/L | Standard Deviation 3.178 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 12 | 0.12 mg/L | Standard Deviation 0.903 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 52 | 0.21 mg/L | Standard Deviation 0.909 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 12 | 0.11 mg/L | Standard Deviation 0.789 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 52 | 0.01 mg/L | Standard Deviation 0.768 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 12 | 0.03 mg/L | Standard Deviation 0.469 |
| Placebo | Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52 | Week 52 | -0.09 mg/L | Standard Deviation 1.126 |
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.
Time frame: Baseline, Week 16/Week 56
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | -10.85 undiluted peanut protein (mm) | Standard Deviation 6.423 |
| Ligelizumab 120 mg | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | -8.40 undiluted peanut protein (mm) | Standard Deviation 5.805 |
| Placebo | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | -5.28 undiluted peanut protein (mm) | Standard Deviation 5.237 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | -7.25 undiluted peanut protein (mm) | Standard Deviation 7.354 |
| Placebo | Change From Baseline in Skin Prick Test (SPT) Mean Wheal Diameters at Week 16/Week 56 | -2.38 undiluted peanut protein (mm) | Standard Deviation 3.788 |
p-value: <0.00195% CI: [-5.15, -2.4]ANCOVA
p-value: <0.00195% CI: [-7.77, -2.09]ANCOVA
p-value: 0.01595% CI: [-6.08, -0.32]ANCOVA
p-value: 0.1395% CI: [-4.62, 1.25]ANCOVA
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).
Time frame: Baseline, Week 12 Part 2 (3 Days After Day 2 Oral Food Challenge (OFC))
Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Physical Component Score | 0.51 Unit on a scale | Standard Deviation 8.022 |
| Ligelizumab 240 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Mental Component Score | -0.15 Unit on a scale | Standard Deviation 9.95 |
| Ligelizumab 120 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Physical Component Score | 0.38 Unit on a scale | Standard Deviation 2.912 |
| Ligelizumab 120 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Mental Component Score | -0.12 Unit on a scale | Standard Deviation 8.175 |
| Placebo | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Physical Component Score | 2.13 Unit on a scale | Standard Deviation 3.909 |
| Placebo | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Mental Component Score | -1.78 Unit on a scale | Standard Deviation 8.458 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Mental Component Score | -3.26 Unit on a scale | Standard Deviation 8.256 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Physical Component Score | -2.19 Unit on a scale | Standard Deviation 5.09 |
| Placebo | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Physical Component Score | 3.15 Unit on a scale | Standard Deviation 5.342 |
| Placebo | Change From Baseline in the SF-36v2 Physical Component Score (PCS) and Mental Component Score (MCS) | Mental Component Score | -9.43 Unit on a scale | Standard Deviation 14.662 |
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.
Time frame: 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))
Population: Full Analysis Set. Only adult participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - RAE | 0.06 Unit on a scale | Standard Deviation 0.647 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - AADR | -0.10 Unit on a scale | Standard Deviation 0.788 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - FAH | -0.47 Unit on a scale | Standard Deviation 0.864 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - Total Score | -0.16 Unit on a scale | Standard Deviation 0.742 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - EI | 0.07 Unit on a scale | Standard Deviation 0.747 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - FAH | -0.17 Unit on a scale | Standard Deviation 1.082 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - RAE | -0.15 Unit on a scale | Standard Deviation 0.75 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - EI | -0.11 Unit on a scale | Standard Deviation 0.98 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - Total Score | -0.01 Unit on a scale | Standard Deviation 0.56 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - AADR | -0.07 Unit on a scale | Standard Deviation 0.609 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - EI | -0.47 Unit on a scale | Standard Deviation 1.006 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - AADR | -0.41 Unit on a scale | Standard Deviation 0.526 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - FAH | -0.73 Unit on a scale | Standard Deviation 0.854 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - AADR | -0.74 Unit on a scale | Standard Deviation 0.585 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - EI | -0.31 Unit on a scale | Standard Deviation 0.838 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - RAE | -0.40 Unit on a scale | Standard Deviation 0.427 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - RAE | -0.31 Unit on a scale | Standard Deviation 0.917 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - Total Score | -0.55 Unit on a scale | Standard Deviation 0.671 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - Total Score | -0.40 Unit on a scale | Standard Deviation 0.439 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - FAH | -0.53 Unit on a scale | Standard Deviation 0.717 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - EI | -0.35 Unit on a scale | Standard Deviation 0.601 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - Total Score | -0.20 Unit on a scale | Standard Deviation 0.601 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - Total Score | -0.60 Unit on a scale | Standard Deviation 0.783 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - EI | -0.90 Unit on a scale | Standard Deviation 1.027 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - AADR | -0.31 Unit on a scale | Standard Deviation 0.805 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - AADR | -0.70 Unit on a scale | Standard Deviation 1.106 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - RAE | 0.02 Unit on a scale | Standard Deviation 0.834 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - RAE | -0.34 Unit on a scale | Standard Deviation 0.468 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - FAH | -0.05 Unit on a scale | Standard Deviation 0.788 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - FAH | -0.22 Unit on a scale | Standard Deviation 0.77 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - Total Score | 0.00 Unit on a scale | Standard Deviation 0.656 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - Total Score | -0.22 Unit on a scale | Standard Deviation 0.727 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - FAH | -0.06 Unit on a scale | Standard Deviation 1.153 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - FAH | 0.06 Unit on a scale | Standard Deviation 1.056 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - EI | -0.04 Unit on a scale | Standard Deviation 0.857 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - RAE | 0.18 Unit on a scale | Standard Deviation 0.794 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - AADR | -0.12 Unit on a scale | Standard Deviation 0.731 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - RAE | -0.26 Unit on a scale | Standard Deviation 0.821 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - AADR | -0.20 Unit on a scale | Standard Deviation 0.749 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - EI | -0.26 Unit on a scale | Standard Deviation 0.828 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - AADR | -0.15 Unit on a scale | Standard Deviation 0.532 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - RAE | 0.10 Unit on a scale | Standard Deviation 0.471 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - EI | -0.06 Unit on a scale | Standard Deviation 0.358 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - FAH | 0.07 Unit on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - RAE | -0.33 Unit on a scale | Standard Deviation 0.549 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - Total Score | -0.14 Unit on a scale | Standard Deviation 0.542 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - FAH | 0.04 Unit on a scale | Standard Deviation 1.073 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - AADR | -0.05 Unit on a scale | Standard Deviation 0.508 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 1 - Total Score | 0.00 Unit on a scale | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF) | Week 12 Part 2 - EI | 0.00 Unit on a scale | Standard Deviation 0.553 |
Comparison: Week 12 Part 1 - Total Scorep-value: 0.59795% CI: [-0.44, 0.57]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.06495% CI: [-0.89, 0.11]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.19195% CI: [-0.72, 0.28]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.47295% CI: [-0.51, 0.48]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.53795% CI: [-0.57, 0.62]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.14195% CI: [-0.91, 0.27]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.06395% CI: [-1.04, 0.13]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.36895% CI: [-0.68, 0.48]ANCOVA
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.
Time frame: 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))
Population: Full Analysis Set. Only adolescent participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - AADR | -0.15 Unit on a scale | Standard Deviation 0.873 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - EI | -0.51 Unit on a scale | Standard Deviation 1.057 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - RAE | -0.28 Unit on a scale | Standard Deviation 0.718 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - EI | -0.03 Unit on a scale | Standard Deviation 0.896 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - RAE | -0.07 Unit on a scale | Standard Deviation 1.085 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - Total Score | -0.09 Unit on a scale | Standard Deviation 0.833 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - AADR | -0.61 Unit on a scale | Standard Deviation 0.946 |
| Ligelizumab 240 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - Total Score | -0.49 Unit on a scale | Standard Deviation 0.839 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - RAE | 0.08 Unit on a scale | Standard Deviation 0.868 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - RAE | -0.04 Unit on a scale | Standard Deviation 1.028 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - Total Score | -0.13 Unit on a scale | Standard Deviation 0.869 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - Total Score | -0.01 Unit on a scale | Standard Deviation 0.779 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - EI | -0.12 Unit on a scale | Standard Deviation 0.846 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - EI | -0.19 Unit on a scale | Standard Deviation 0.875 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - AADR | 0.02 Unit on a scale | Standard Deviation 0.977 |
| Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - AADR | -0.14 Unit on a scale | Standard Deviation 1.004 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - EI | -0.23 Unit on a scale | Standard Deviation 0.737 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - Total Score | -0.08 Unit on a scale | Standard Deviation 0.879 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - RAE | -0.10 Unit on a scale | Standard Deviation 0.796 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - AADR | -0.08 Unit on a scale | Standard Deviation 1.291 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - RAE | 0.08 Unit on a scale | Standard Deviation 0.733 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - EI | -0.40 Unit on a scale | Standard Deviation 0.745 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - AADR | -0.35 Unit on a scale | Standard Deviation 0.988 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - Total Score | -0.30 Unit on a scale | Standard Deviation 0.647 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - AADR | -0.11 Unit on a scale | Standard Deviation 1.13 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - EI | -0.05 Unit on a scale | Standard Deviation 1.348 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - Total Score | -0.07 Unit on a scale | Standard Deviation 0.972 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - RAE | 0.02 Unit on a scale | Standard Deviation 1.016 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - Total Score | 0.04 Unit on a scale | Standard Deviation 1.255 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - RAE | 0.03 Unit on a scale | Standard Deviation 1.366 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - AADR | 0.12 Unit on a scale | Standard Deviation 1.235 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - EI | -0.11 Unit on a scale | Standard Deviation 1.062 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - RAE | -0.04 Unit on a scale | Standard Deviation 1.253 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - Total Score | 0.27 Unit on a scale | Standard Deviation 0.835 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - Total Score | 0.09 Unit on a scale | Standard Deviation 0.954 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - EI | 0.27 Unit on a scale | Standard Deviation 1.034 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - EI | -0.04 Unit on a scale | Standard Deviation 1.486 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 2 - AADR | 0.25 Unit on a scale | Standard Deviation 0.628 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - RAE | 0.54 Unit on a scale | Standard Deviation 1.204 |
| Placebo | Change From Baseline in Total and Domain Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF) | Week 12 Part 1 - AADR | 0.11 Unit on a scale | Standard Deviation 0.599 |
Comparison: Week 12 Part 1 - Total Scorep-value: 0.17395% CI: [-1.03, 0.36]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.20295% CI: [-0.96, 0.39]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.15195% CI: [-1.09, 0.34]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.26495% CI: [-0.94, 0.49]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.12395% CI: [-1.16, 0.3]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.25895% CI: [-0.94, 0.47]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.32495% CI: [-0.92, 0.58]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.47395% CI: [-0.78, 0.73]ANCOVA
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.
Time frame: 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))
Population: Full Analysis Set. Only adult participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 1 - Total Score | 0.17 Unit on a scale | Standard Deviation 0.574 |
| Ligelizumab 240 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 2 - Total Score | -0.23 Unit on a scale | Standard Deviation 0.681 |
| Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 1 - Total Score | -0.23 Unit on a scale | Standard Deviation 0.496 |
| Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 2 - Total Score | -0.36 Unit on a scale | Standard Deviation 0.562 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 1 - Total Score | -0.09 Unit on a scale | Standard Deviation 0.694 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 2 - Total Score | -0.27 Unit on a scale | Standard Deviation 0.492 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 2 - Total Score | -0.24 Unit on a scale | Standard Deviation 0.479 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 1 - Total Score | 0.00 Unit on a scale | Standard Deviation 0.489 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 1 - Total Score | 0.17 Unit on a scale | Standard Deviation 0.309 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Adult Form (FAIM-AF) | Week 12 Part 2 - Total Score | 0.07 Unit on a scale | Standard Deviation 0.703 |
Comparison: Week 12 Part 2 - Total Scorep-value: 0.07195% CI: [-0.98, 0.14]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.57495% CI: [-0.42, 0.51]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.05695% CI: [-0.83, 0.09]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.06995% CI: [-0.83, 0.12]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.20595% CI: [-0.65, 0.27]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.24895% CI: [-0.76, 0.37]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.04895% CI: [-1.06, 0.09]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.14295% CI: [-0.85, 0.25]ANCOVA
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.
Time frame: 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))
Population: Full Analysis Set. Only adolescent participants with a value at both Baseline and post-baseline visit included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ligelizumab 240 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 1 - Total Score | -0.03 Unit on a scale | Standard Deviation 0.751 |
| Ligelizumab 240 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 2 - Total Score | -0.31 Unit on a scale | Standard Deviation 0.952 |
| Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 1 - Total Score | -0.11 Unit on a scale | Standard Deviation 0.76 |
| Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 2 - Total Score | 0.31 Unit on a scale | Standard Deviation 0.784 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 1 - Total Score | -0.04 Unit on a scale | Standard Deviation 0.529 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 2 - Total Score | -0.07 Unit on a scale | Standard Deviation 0.524 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 2 - Total Score | 0.39 Unit on a scale | Standard Deviation 1.133 |
| Placebo 8 Weeks and Ligelizumab 120 mg | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 1 - Total Score | 0.31 Unit on a scale | Standard Deviation 0.989 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 1 - Total Score | 0.19 Unit on a scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) - Teenager Form (FAIM-TF) | Week 12 Part 2 - Total Score | 0.25 Unit on a scale | Standard Deviation 1.306 |
Comparison: Week 12 Part 1 - Total Scorep-value: 0.22595% CI: [-0.87, 0.39]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.15395% CI: [-0.93, 0.3]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.17995% CI: [-0.95, 0.34]ANCOVA
Comparison: Week 12 Part 1 - Total Scorep-value: 0.63195% CI: [-0.55, 0.77]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.0695% CI: [-1.18, 0.14]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.40495% CI: [-0.72, 0.56]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.13595% CI: [-1.06, 0.3]ANCOVA
Comparison: Week 12 Part 2 - Total Scorep-value: 0.51495% CI: [-0.7, 0.72]ANCOVA
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.
Time frame: Week 12
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ligelizumab 240 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | None | 5 Participants |
| Ligelizumab 240 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Mild | 15 Participants |
| Ligelizumab 240 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Moderate | 24 Participants |
| Ligelizumab 240 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Severe | 3 Participants |
| Ligelizumab 120 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Severe | 2 Participants |
| Ligelizumab 120 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | None | 2 Participants |
| Ligelizumab 120 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Moderate | 37 Participants |
| Ligelizumab 120 mg | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Mild | 10 Participants |
| Placebo | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Severe | 8 Participants |
| Placebo | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Mild | 2 Participants |
| Placebo | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | Moderate | 13 Participants |
| Placebo | Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12 | None | 0 Participants |
p-value: <0.00195% CI: [3.63, 31.56]proportional odds model
p-value: 0.00195% CI: [1.8, 14.36]proportional odds model
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.
Time frame: Week 12
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligelizumab 240 mg | 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 | 14 Participants |
| Ligelizumab 120 mg | 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 | 6 Participants |
| Placebo | 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 | 1 Participants |
p-value: 0.01895% CI: [1.69, 188.85]Regression, Logistic
p-value: 0.16495% CI: [0.45, 59.93]Regression, Logistic
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.
Time frame: Week 12
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligelizumab 240 mg | 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 | 8 Participants |
| Ligelizumab 120 mg | 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 | 1 Participants |
| Placebo | 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 | 1 Participants |
p-value: 0.08295% CI: [0.74, 93.16]Regression, Logistic
p-value: 0.63295% CI: [0.02, 16.43]Regression, Logistic
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.
Time frame: Week 12
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ligelizumab 240 mg | 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 | 7 Participants |
| Ligelizumab 120 mg | 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 | 5 Participants |
| Placebo | 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 | 1 Participants |
p-value: 0.13895% CI: [0.51, 70.08]Regression, Logistic
p-value: 0.24795% CI: [0.3, 45.56]Regression, Logistic
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.
Time frame: Week 52
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ligelizumab 240 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 600 mg | 2 Participants |
| Ligelizumab 240 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD = 3000 mg | 1 Participants |
| Ligelizumab 240 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 1000 mg | 1 Participants |
| Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 600 mg | 1 Participants |
| Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD = 3000 mg | 1 Participants |
| Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 1000 mg | 1 Participants |
| Placebo | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 1000 mg | 0 Participants |
| Placebo | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 600 mg | 0 Participants |
| Placebo | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD = 3000 mg | 0 Participants |
| Placebo 8 Weeks and Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 600 mg | 1 Participants |
| Placebo 8 Weeks and Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD = 3000 mg | 0 Participants |
| Placebo 8 Weeks and Ligelizumab 120 mg | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD >= 1000 mg | 0 Participants |
| Placebo | Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 | MTD = 3000 mg | 0 Participants |