Trial Outcomes & Findings for Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy (NCT NCT04984876)

Last Updated: 2025-04-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

211 participants

Primary outcome timeframe

Week 12

Results posted on

2025-04-29

Participant Flow

This study was conducted in 56 centers in 10 countries worldwide

Participant milestones

Participant milestones
Measure	Ligelizumab 240 mg ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo 8 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks	Placebo 8 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo 16 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks	Placebo 16 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks
Overall Study STARTED	47	51	46	44	11	12
Overall Study Randomized Analysis Set (RAS)	47	51	46	44	11	12
Overall Study Full Analysis Set (FAS)	47	51	46	44	11	12
Overall Study Safety Set (SAF)	47	51	46	44	11	12
Overall Study COMPLETED	44	40	41	37	8	11
Overall Study NOT COMPLETED	3	11	5	7	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ligelizumab 240 mg ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo 8 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks	Placebo 8 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo 16 Weeks and Ligelizumab 240 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks	Placebo 16 Weeks and Ligelizumab 120 mg Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks
Overall Study Subject decision	2	10	3	3	3	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 Adverse Event	0	0	1	0	0	0

Baseline Characteristics

Participants for which baseline data are not available are not counted.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ligelizumab 240 mg n=47 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=51 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo 8 Weeks and Ligelizumab 240 mg n=46 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks	Placebo 8 Weeks and Ligelizumab 120 mg n=44 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo 16 Weeks and Ligelizumab 240 mg n=11 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 240 mg subcutaneous injection for 36 weeks	Placebo 16 Weeks and Ligelizumab 120 mg n=12 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg subcutaneous injection for 36 weeks	Total n=211 Participants Total of all reporting groups
Age, Continuous	19.5 Years STANDARD_DEVIATION 7.50 • n=47 Participants	18.8 Years STANDARD_DEVIATION 6.27 • n=51 Participants	18.7 Years STANDARD_DEVIATION 6.95 • n=46 Participants	20.0 Years STANDARD_DEVIATION 7.75 • n=44 Participants	17.4 Years STANDARD_DEVIATION 4.57 • n=11 Participants	16.1 Years STANDARD_DEVIATION 3.58 • n=12 Participants	18.9 Years STANDARD_DEVIATION 6.85 • n=211 Participants
Age, Customized 12 - 17 years	27 Participants n=47 Participants	29 Participants n=51 Participants	25 Participants n=46 Participants	24 Participants n=44 Participants	6 Participants n=11 Participants	8 Participants n=12 Participants	119 Participants n=211 Participants
Age, Customized 18 - 55 years	20 Participants n=47 Participants	22 Participants n=51 Participants	21 Participants n=46 Participants	20 Participants n=44 Participants	5 Participants n=11 Participants	4 Participants n=12 Participants	92 Participants n=211 Participants
Sex: Female, Male Female	25 Participants n=47 Participants	25 Participants n=51 Participants	19 Participants n=46 Participants	20 Participants n=44 Participants	3 Participants n=11 Participants	6 Participants n=12 Participants	98 Participants n=211 Participants
Sex: Female, Male Male	22 Participants n=47 Participants	26 Participants n=51 Participants	27 Participants n=46 Participants	24 Participants n=44 Participants	8 Participants n=11 Participants	6 Participants n=12 Participants	113 Participants n=211 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants	0 Participants n=51 Participants	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=211 Participants
Race (NIH/OMB) Asian	8 Participants n=47 Participants	10 Participants n=51 Participants	2 Participants n=46 Participants	1 Participants n=44 Participants	2 Participants n=11 Participants	2 Participants n=12 Participants	25 Participants n=211 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	0 Participants n=51 Participants	0 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	0 Participants n=211 Participants
Race (NIH/OMB) Black or African American	6 Participants n=47 Participants	3 Participants n=51 Participants	1 Participants n=46 Participants	2 Participants n=44 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	12 Participants n=211 Participants
Race (NIH/OMB) White	31 Participants n=47 Participants	36 Participants n=51 Participants	42 Participants n=46 Participants	39 Participants n=44 Participants	7 Participants n=11 Participants	10 Participants n=12 Participants	165 Participants n=211 Participants
Race (NIH/OMB) More than one race	1 Participants n=47 Participants	1 Participants n=51 Participants	0 Participants n=46 Participants	2 Participants n=44 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	5 Participants n=211 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=47 Participants	1 Participants n=51 Participants	1 Participants n=46 Participants	0 Participants n=44 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	4 Participants n=211 Participants
Time to diagnosis of peanut allergy	16.287 Years STANDARD_DEVIATION 7.9393 • n=47 Participants	16.381 Years STANDARD_DEVIATION 6.9248 • n=51 Participants	15.556 Years STANDARD_DEVIATION 7.5799 • n=46 Participants	17.748 Years STANDARD_DEVIATION 7.8969 • n=44 Participants	15.598 Years STANDARD_DEVIATION 5.3525 • n=11 Participants	14.971 Years STANDARD_DEVIATION 3.5291 • n=12 Participants	16.344 Years STANDARD_DEVIATION 7.2808 • n=211 Participants
Number of participants with at least one food allergy 1 food allergy	12 Participants n=47 Participants	15 Participants n=51 Participants	13 Participants n=46 Participants	11 Participants n=44 Participants	5 Participants n=11 Participants	3 Participants n=12 Participants	59 Participants n=211 Participants
Number of participants with at least one food allergy 2 food allergies	10 Participants n=47 Participants	5 Participants n=51 Participants	8 Participants n=46 Participants	4 Participants n=44 Participants	1 Participants n=11 Participants	1 Participants n=12 Participants	29 Participants n=211 Participants
Number of participants with at least one food allergy 3 food allergies	5 Participants n=47 Participants	5 Participants n=51 Participants	2 Participants n=46 Participants	5 Participants n=44 Participants	3 Participants n=11 Participants	1 Participants n=12 Participants	21 Participants n=211 Participants
Number of participants with at least one food allergy 4 food allergies	8 Participants n=47 Participants	7 Participants n=51 Participants	6 Participants n=46 Participants	4 Participants n=44 Participants	0 Participants n=11 Participants	1 Participants n=12 Participants	26 Participants n=211 Participants
Number of participants with at least one food allergy 5 food allergies	0 Participants n=47 Participants	4 Participants n=51 Participants	4 Participants n=46 Participants	3 Participants n=44 Participants	1 Participants n=11 Participants	2 Participants n=12 Participants	14 Participants n=211 Participants
Number of participants with at least one food allergy > 5 food allergies	12 Participants n=47 Participants	15 Participants n=51 Participants	13 Participants n=46 Participants	17 Participants n=44 Participants	1 Participants n=11 Participants	4 Participants n=12 Participants	62 Participants n=211 Participants
Peanut specific Immunoglobulin E (IgE)	109.021 IU/mL STANDARD_DEVIATION 147.9877 • n=47 Participants	80.644 IU/mL STANDARD_DEVIATION 117.6312 • n=51 Participants	131.948 IU/mL STANDARD_DEVIATION 189.7757 • n=46 Participants	116.198 IU/mL STANDARD_DEVIATION 128.9151 • n=44 Participants	51.606 IU/mL STANDARD_DEVIATION 48.6951 • n=11 Participants	262.136 IU/mL STANDARD_DEVIATION 543.7764 • n=12 Participants	114.372 IU/mL STANDARD_DEVIATION 191.3605 • n=211 Participants
Total Immunoglobulin E (IgE)	524.35 IU/mL STANDARD_DEVIATION 444.009 • n=47 Participants	482.25 IU/mL STANDARD_DEVIATION 478.047 • n=51 Participants	455.38 IU/mL STANDARD_DEVIATION 397.960 • n=46 Participants	436.31 IU/mL STANDARD_DEVIATION 335.113 • n=44 Participants	325.15 IU/mL STANDARD_DEVIATION 208.482 • n=11 Participants	635.42 IU/mL STANDARD_DEVIATION 535.099 • n=12 Participants	476.81 IU/mL STANDARD_DEVIATION 418.656 • n=211 Participants
MTD (maximum tolerated dose) of peanut protein (mg) - n (%) < 1 mg	2 Participants n=47 Participants	5 Participants n=51 Participants	2 Participants n=46 Participants	2 Participants n=44 Participants	1 Participants n=11 Participants	0 Participants n=12 Participants	12 Participants n=211 Participants
MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 1 mg	4 Participants n=47 Participants	4 Participants n=51 Participants	6 Participants n=46 Participants	9 Participants n=44 Participants	1 Participants n=11 Participants	2 Participants n=12 Participants	26 Participants n=211 Participants
MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 3 mg	14 Participants n=47 Participants	14 Participants n=51 Participants	11 Participants n=46 Participants	11 Participants n=44 Participants	1 Participants n=11 Participants	1 Participants n=12 Participants	52 Participants n=211 Participants
MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 10 mg	9 Participants n=47 Participants	14 Participants n=51 Participants	7 Participants n=46 Participants	11 Participants n=44 Participants	4 Participants n=11 Participants	5 Participants n=12 Participants	50 Participants n=211 Participants
MTD (maximum tolerated dose) of peanut protein (mg) - n (%) 30 mg	18 Participants n=47 Participants	14 Participants n=51 Participants	20 Participants n=46 Participants	11 Participants n=44 Participants	4 Participants n=11 Participants	4 Participants n=12 Participants	71 Participants n=211 Participants
Peanut Skin Prick Test (SPT) (undiluted): Size of mean wheal diameter	13.83 mm STANDARD_DEVIATION 5.720 • n=47 Participants • Participants for which baseline data are not available are not counted.	14.61 mm STANDARD_DEVIATION 6.007 • n=51 Participants • Participants for which baseline data are not available are not counted.	13.23 mm STANDARD_DEVIATION 6.414 • n=45 Participants • Participants for which baseline data are not available are not counted.	16.82 mm STANDARD_DEVIATION 8.262 • n=44 Participants • Participants for which baseline data are not available are not counted.	14.45 mm STANDARD_DEVIATION 4.845 • n=10 Participants • Participants for which baseline data are not available are not counted.	12.17 mm STANDARD_DEVIATION 3.664 • n=12 Participants • Participants for which baseline data are not available are not counted.	14.45 mm STANDARD_DEVIATION 6.508 • n=209 Participants • Participants for which baseline data are not available are not counted.
Peanut Skin Prick Test (SPT) (average across dilutions): Size of mean wheal diameter	7.232 mm STANDARD_DEVIATION 2.8339 • n=47 Participants • Participants for which baseline data are not available are not counted.	7.273 mm STANDARD_DEVIATION 2.7253 • n=51 Participants • Participants for which baseline data are not available are not counted.	7.508 mm STANDARD_DEVIATION 2.7624 • n=46 Participants • Participants for which baseline data are not available are not counted.	7.907 mm STANDARD_DEVIATION 2.8866 • n=44 Participants • Participants for which baseline data are not available are not counted.	6.575 mm STANDARD_DEVIATION 2.3809 • n=10 Participants • Participants for which baseline data are not available are not counted.	7.743 mm STANDARD_DEVIATION 2.3547 • n=12 Participants • Participants for which baseline data are not available are not counted.	7.442 mm STANDARD_DEVIATION 2.7463 • n=210 Participants • Participants for which baseline data are not available are not counted.
Poly-sensitized to food Yes	29 Participants n=47 Participants	27 Participants n=51 Participants	22 Participants n=46 Participants	27 Participants n=44 Participants	8 Participants n=11 Participants	8 Participants n=12 Participants	121 Participants n=211 Participants
Poly-sensitized to food No	18 Participants n=47 Participants	24 Participants n=51 Participants	24 Participants n=46 Participants	17 Participants n=44 Participants	3 Participants n=11 Participants	4 Participants n=12 Participants	90 Participants n=211 Participants
Poly-allergic to food Yes	35 Participants n=47 Participants	36 Participants n=51 Participants	33 Participants n=46 Participants	33 Participants n=44 Participants	6 Participants n=11 Participants	9 Participants n=12 Participants	152 Participants n=211 Participants
Poly-allergic to food No	12 Participants n=47 Participants	15 Participants n=51 Participants	13 Participants n=46 Participants	11 Participants n=44 Participants	5 Participants n=11 Participants	3 Participants n=12 Participants	59 Participants n=211 Participants
History of anaphylactic reaction to food Yes	32 Participants n=47 Participants	36 Participants n=51 Participants	29 Participants n=46 Participants	32 Participants n=44 Participants	9 Participants n=11 Participants	8 Participants n=12 Participants	146 Participants n=211 Participants
History of anaphylactic reaction to food No	14 Participants n=47 Participants	15 Participants n=51 Participants	16 Participants n=46 Participants	12 Participants n=44 Participants	2 Participants n=11 Participants	4 Participants n=12 Participants	63 Participants n=211 Participants
History of anaphylactic reaction to food Unknown	1 Participants n=47 Participants	0 Participants n=51 Participants	1 Participants n=46 Participants	0 Participants n=44 Participants	0 Participants n=11 Participants	0 Participants n=12 Participants	2 Participants n=211 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=47 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=51 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=23 Participants 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	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	8 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=47 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=51 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=23 Participants 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	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	6 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=47 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=51 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=23 Participants 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	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	5 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=47 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=51 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=23 Participants 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	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	2 Participants	0 Participants	—	—
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	10 Participants	2 Participants	—	—
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	37 Participants	13 Participants	—	—
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	2 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=46 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=44 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=23 Participants 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	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=3 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=2 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=2 Participants 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 n=4 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 MTD >= 600 mg	2 Participants	1 Participants	0 Participants	1 Participants	—
Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 MTD >= 1000 mg	1 Participants	1 Participants	0 Participants	0 Participants	—
Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52 MTD = 3000 mg	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=45 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=48 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=46 Participants 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 n=40 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=20 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	104.31 mg Geometric Coefficient of Variation 794.248	148.98 mg Geometric Coefficient of Variation 754.171	44.29 mg Geometric Coefficient of Variation 768.803	46.62 mg Geometric Coefficient of Variation 555.207
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	164.23 mg Geometric Coefficient of Variation 459916.375	89.55 mg Geometric Coefficient of Variation 408.957	146.48 mg Geometric Coefficient of Variation 113.009	—

SECONDARY outcome

Timeframe: 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.

Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE)

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=44 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=46 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=45 Participants 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 n=39 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=20 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	295.60 kilounits per liter (kU/L) Standard Deviation 321.451	302.22 kilounits per liter (kU/L) Standard Deviation 323.846	400.03 kilounits per liter (kU/L) Standard Deviation 611.676	-35.52 kilounits per liter (kU/L) Standard Deviation 179.040
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	297.94 kilounits per liter (kU/L) Standard Deviation 285.827	338.63 kilounits per liter (kU/L) Standard Deviation 435.532	361.44 kilounits per liter (kU/L) Standard Deviation 587.852	174.75 kilounits per liter (kU/L) Standard Deviation 433.889

SECONDARY outcome

Timeframe: 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.

Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4)

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=46 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=46 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=45 Participants 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 n=40 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=19 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	0.35 mg/L Standard Deviation 3.178	0.12 mg/L Standard Deviation 0.903	0.11 mg/L Standard Deviation 0.789	0.03 mg/L Standard Deviation 0.469
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	0.73 mg/L Standard Deviation 3.103	0.21 mg/L Standard Deviation 0.909	0.01 mg/L Standard Deviation 0.768	-0.09 mg/L Standard Deviation 1.126

SECONDARY outcome

Timeframe: Baseline, Week 16/Week 56

Population: Full Analysis Set. Only participants with a value at both Baseline and post-baseline visit included.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=36 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=40 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=37 Participants 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 n=36 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=16 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	-8.40 undiluted peanut protein (mm) Standard Deviation 5.805	-5.28 undiluted peanut protein (mm) Standard Deviation 5.237	-7.25 undiluted peanut protein (mm) Standard Deviation 7.354	-2.38 undiluted peanut protein (mm) Standard Deviation 3.788

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=17 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=20 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=15 Participants 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 n=16 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=9 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	-0.01 Unit on a scale Standard Deviation 0.779	-0.30 Unit on a scale Standard Deviation 0.647	-0.07 Unit on a scale Standard Deviation 0.972	0.27 Unit on a scale Standard Deviation 0.835
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	-0.13 Unit on a scale Standard Deviation 0.869	-0.08 Unit on a scale Standard Deviation 0.879	0.04 Unit on a scale Standard Deviation 1.255	0.09 Unit on a scale Standard Deviation 0.954
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	-0.12 Unit on a scale Standard Deviation 0.846	-0.40 Unit on a scale Standard Deviation 0.745	-0.11 Unit on a scale Standard Deviation 1.062	0.27 Unit on a scale Standard Deviation 1.034
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	-0.19 Unit on a scale Standard Deviation 0.875	-0.23 Unit on a scale Standard Deviation 0.737	-0.05 Unit on a scale Standard Deviation 1.348	-0.04 Unit on a scale Standard Deviation 1.486
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	0.02 Unit on a scale Standard Deviation 0.977	-0.35 Unit on a scale Standard Deviation 0.988	-0.11 Unit on a scale Standard Deviation 1.130	0.11 Unit on a scale Standard Deviation 0.599
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	-0.14 Unit on a scale Standard Deviation 1.004	-0.08 Unit on a scale Standard Deviation 1.291	0.12 Unit on a scale Standard Deviation 1.235	0.25 Unit on a scale Standard Deviation 0.628
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	0.08 Unit on a scale Standard Deviation 0.868	-0.10 Unit on a scale Standard Deviation 0.796	0.02 Unit on a scale Standard Deviation 1.016	0.54 Unit on a scale Standard Deviation 1.204
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	-0.04 Unit on a scale Standard Deviation 1.028	0.08 Unit on a scale Standard Deviation 0.733	0.03 Unit on a scale Standard Deviation 1.366	-0.04 Unit on a scale Standard Deviation 1.253

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=16 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=17 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=19 Participants 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 n=17 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=9 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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 0.560	-0.40 Unit on a scale Standard Deviation 0.439	-0.20 Unit on a scale Standard Deviation 0.601	0.00 Unit on a scale Standard Deviation 0.656	0.00 Unit on a scale Standard Deviation 0.330
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	-0.55 Unit on a scale Standard Deviation 0.671	-0.60 Unit on a scale Standard Deviation 0.783	-0.22 Unit on a scale Standard Deviation 0.727	-0.14 Unit on a scale Standard Deviation 0.542
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	-0.31 Unit on a scale Standard Deviation 0.838	-0.35 Unit on a scale Standard Deviation 0.601	-0.04 Unit on a scale Standard Deviation 0.857	-0.06 Unit on a scale Standard Deviation 0.358
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 0.980	-0.47 Unit on a scale Standard Deviation 1.006	-0.90 Unit on a scale Standard Deviation 1.027	-0.26 Unit on a scale Standard Deviation 0.828	0.00 Unit on a scale Standard Deviation 0.553
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	-0.41 Unit on a scale Standard Deviation 0.526	-0.31 Unit on a scale Standard Deviation 0.805	-0.12 Unit on a scale Standard Deviation 0.731	-0.05 Unit on a scale Standard Deviation 0.508
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	-0.74 Unit on a scale Standard Deviation 0.585	-0.70 Unit on a scale Standard Deviation 1.106	-0.20 Unit on a scale Standard Deviation 0.749	-0.15 Unit on a scale Standard Deviation 0.532
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	-0.40 Unit on a scale Standard Deviation 0.427	0.02 Unit on a scale Standard Deviation 0.834	0.18 Unit on a scale Standard Deviation 0.794	0.10 Unit on a scale Standard Deviation 0.471
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 0.750	-0.31 Unit on a scale Standard Deviation 0.917	-0.34 Unit on a scale Standard Deviation 0.468	-0.26 Unit on a scale Standard Deviation 0.821	-0.33 Unit on a scale Standard Deviation 0.549
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	-0.53 Unit on a scale Standard Deviation 0.717	-0.05 Unit on a scale Standard Deviation 0.788	0.06 Unit on a scale Standard Deviation 1.056	0.04 Unit on a scale Standard Deviation 1.073
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	-0.73 Unit on a scale Standard Deviation 0.854	-0.22 Unit on a scale Standard Deviation 0.770	-0.06 Unit on a scale Standard Deviation 1.153	0.07 Unit on a scale Standard Deviation 1.140

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=17 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=19 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=15 Participants 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 n=14 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=9 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	-0.11 Unit on a scale Standard Deviation 0.760	-0.04 Unit on a scale Standard Deviation 0.529	0.31 Unit on a scale Standard Deviation 0.989	0.19 Unit on a scale Standard Deviation 0.930
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	0.31 Unit on a scale Standard Deviation 0.784	-0.07 Unit on a scale Standard Deviation 0.524	0.39 Unit on a scale Standard Deviation 1.133	0.25 Unit on a scale Standard Deviation 1.306

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ligelizumab 240 mg n=16 Participants ligelizumab 240 mg subcutaneous injection for 52 weeks	Ligelizumab 120 mg n=17 Participants ligelizumab 120 mg subcutaneous injection for 52 weeks	Placebo n=16 Participants 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 n=17 Participants Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks	Placebo n=8 Participants Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks
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	-0.23 Unit on a scale Standard Deviation 0.496	-0.09 Unit on a scale Standard Deviation 0.694	0.00 Unit on a scale Standard Deviation 0.489	0.17 Unit on a scale Standard Deviation 0.309
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	-0.36 Unit on a scale Standard Deviation 0.562	-0.27 Unit on a scale Standard Deviation 0.492	-0.24 Unit on a scale Standard Deviation 0.479	0.07 Unit on a scale Standard Deviation 0.703

SECONDARY outcome

Timeframe: 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.

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).