Trial Outcomes & Findings for Long-term Extension Study of Ligelizumab in Food Allergy (NCT NCT05678959)

Last Updated: 2026-01-13

Results Overview

TEAEs were defined as events where an AE either started after the first dose of extension study treatment and within 16 weeks after the last administered study treatment dose or began prior to the first dose of study treatment but increased in severity (based on preferred term) within 16 weeks after the last study treatment.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

163 participants

Primary outcome timeframe

Up to approximately 81 weeks

Results posted on

2026-01-13

Participant Flow

164 participants were screened in this study, of which one was a screen failure; 163 participants received study treatment.

Participant milestones

Participant milestones
Measure	Ligelizumab 120 mg Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg Participants received ligelizumab 240 mg every 4 weeks.
Overall Study STARTED	81	82
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	81	82

Reasons for withdrawal

Reasons for withdrawal
Measure	Ligelizumab 120 mg Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg Participants received ligelizumab 240 mg every 4 weeks.
Overall Study Study Terminated by Sponsor	76	76
Overall Study Physician Decision	2	3
Overall Study Adverse Event	1	1
Overall Study Guardian Decision	1	0
Overall Study Protocol Deviation	0	1
Overall Study Subject Decision	1	0
Overall Study Technical Problem	0	1

Baseline Characteristics

Long-term Extension Study of Ligelizumab in Food Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ligelizumab 120 mg n=81 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=82 Participants Participants received ligelizumab 240 mg every 4 weeks.	Total n=163 Participants Total of all reporting groups
Age, Continuous	19.4 years STANDARD_DEVIATION 6.95 • n=210 Participants	18.9 years STANDARD_DEVIATION 6.23 • n=19 Participants	19.2 years STANDARD_DEVIATION 6.58 • n=123 Participants
Age, Customized 12 - 17 years	41 participants n=210 Participants	46 participants n=19 Participants	87 participants n=123 Participants
Age, Customized 18 - 55 years	40 participants n=210 Participants	36 participants n=19 Participants	76 participants n=123 Participants
Sex: Female, Male Female	37 Participants n=210 Participants	36 Participants n=19 Participants	73 Participants n=123 Participants
Sex: Female, Male Male	44 Participants n=210 Participants	46 Participants n=19 Participants	90 Participants n=123 Participants
Race/Ethnicity, Customized White	58 participants n=210 Participants	61 participants n=19 Participants	119 participants n=123 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=210 Participants	4 participants n=19 Participants	8 participants n=123 Participants
Race/Ethnicity, Customized Asian	12 participants n=210 Participants	10 participants n=19 Participants	22 participants n=123 Participants
Race/Ethnicity, Customized Multiple	1 participants n=210 Participants	1 participants n=19 Participants	2 participants n=123 Participants
Race/Ethnicity, Customized Not Reported	6 participants n=210 Participants	6 participants n=19 Participants	12 participants n=123 Participants

PRIMARY outcome

Timeframe: Up to approximately 81 weeks

Population: Safety Set 1 included all participants who received at least one dose of study treatment during the extension study.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=81 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=82 Participants Participants received ligelizumab 240 mg every 4 weeks.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	84.0 percentage of participants	69.5 percentage of participants
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	3.7 percentage of participants	2.4 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Data are reported for participants who responded and had an evaluable value.

Assessed during an open-label oral food challenge (OFC). If missing Week 52-OFC assessments, Week 156-OFC assessments were performed within 380 days (inclusive) after first extension dose date and considered as Week 52-OFC assessments.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=2 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg Participants received ligelizumab 240 mg every 4 weeks.
Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms	1 Participants	—

SECONDARY outcome

Timeframe: Up to approximately 81 weeks

Population: Safety Set 1 included all participants who received at least one dose of study treatment during the extension study. Number analyzed is the number of participants with available data.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=36 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=46 Participants Participants received ligelizumab 240 mg every 4 weeks.
Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug TEAEs	86.1 percentage of participants	67.4 percentage of participants
Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug TESAEs	5.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included.

The FAQLQ-TF is a self-reported instrument designed for adolescents aged 13-17 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes three domains (emotional impact, allergen avoidance and dietary restrictions, and risk of accidental exposure). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=1 Participants Participants received ligelizumab 240 mg every 4 weeks.
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)	—	1.13 Unit on a scale Standard Deviation NA Standard deviation was not calculable due to the single data point.

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included.

The FAQLQ-AF is a self-reported instrument designed for adults aged 18-55 to assess the impact of food allergy on health-related quality of life (HRQoL). The questionnaire includes four domains (emotional impact, allergen avoidance and dietary restrictions, risk of accidental exposure, and food allergy-related health). Each item was scored on a 7-point scale, with a higher score indicating greater impairment in HRQoL. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the impairment in HRQoL. OFC = oral food challenge.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=4 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=2 Participants Participants received ligelizumab 240 mg every 4 weeks.
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)	0.32 Unit on a scale Standard Deviation 0.873	0.29 Unit on a scale Standard Deviation 1.048

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included.

The FAIM-TF is a self-reported instrument designed for adolescents aged 13-17. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions. The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=1 Participants Participants received ligelizumab 240 mg every 4 weeks.
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)	—	0.33 Unit on a scale Standard Deviation NA Standard deviation was not calculable due to the single data point.

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included.

The FAIM-AF is a self-reported instrument designed for adults aged 18-55. It aims to reflect the participant's perceived food allergy severity and food allergy-related risk. The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes, and the remaining two questions reflect aspects of the perceived severity of food allergy. The total score was calculated as the arithmetic average of all completed items. the range for each item and the total score is from 1 (minimum) to 7 (maximum). The possible range for the total score was 1 (minimum) to 7 (maximum). The higher the score, the greater the perceived risk or chance of adverse events occurring. OFC = oral food challenge.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=3 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=2 Participants Participants received ligelizumab 240 mg every 4 weeks.
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF)	-0.44 Unit on a scale Standard Deviation 0.385	0.42 Unit on a scale Standard Deviation 1.296

SECONDARY outcome

Timeframe: Up to approximately 97 weeks

Population: The full analysis set included all participants who enrolled into the extension study without screen-failure and who received at least one dose of study treatment during any core study. Only participants with a value at both the baseline and post-baseline visits were included.

The SF-36v2 Health Survey is a 36-item instrument that measures generic health-related quality of life. It contains 8 scales and 2 component summary indices evaluating physical, social, and emotional functioning in addition to general health perceptions and mental health. PCS and MCS scores range from 0 to 100, with higher scores indicating better health outcomes.

Outcome measures

Outcome measures
Measure	Ligelizumab 120 mg n=3 Participants Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=2 Participants Participants received ligelizumab 240 mg every 4 weeks.
Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) PCS	0.3 Unit on a scale Standard Deviation 5.03	7.0 Unit on a scale Standard Deviation 11.31
Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS) MCS	0.0 Unit on a scale Standard Deviation 6.00	-13.0 Unit on a scale Standard Deviation 21.21

Adverse Events

Ligelizumab 120 mg

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

Ligelizumab 240 mg

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ligelizumab 120 mg n=81 participants at risk Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=82 participants at risk Participants received ligelizumab 240 mg every 4 weeks.
Cardiac disorders Cardiomyopathy	0.00% 0/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	1.2% 1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Gastrointestinal disorders Colitis	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Gastrointestinal disorders Lip swelling	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Gastrointestinal disorders Nausea	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Gastrointestinal disorders Swollen tongue	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
General disorders and administration site conditions Swelling face	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Immune system disorders Anaphylactic reaction	0.00% 0/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	1.2% 1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Metabolism and nutrition disorders Type 1 diabetes mellitus	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Respiratory, thoracic and mediastinal disorders Throat irritation	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Skin and subcutaneous tissue disorders Pruritus allergic	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	0.00% 0/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.

Other adverse events

Other adverse events
Measure	Ligelizumab 120 mg n=81 participants at risk Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Ligelizumab 240 mg n=82 participants at risk Participants received ligelizumab 240 mg every 4 weeks.
General disorders and administration site conditions Injection site erythema	8.6% 7/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	17.1% 14/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
General disorders and administration site conditions Injection site induration	1.2% 1/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	7.3% 6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
General disorders and administration site conditions Injection site oedema	4.9% 4/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	13.4% 11/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
General disorders and administration site conditions Injection site swelling	2.5% 2/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	8.5% 7/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations COVID-19	7.4% 6/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	8.5% 7/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations Gastroenteritis	2.5% 2/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	7.3% 6/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations Influenza	11.1% 9/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	4.9% 4/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations Nasopharyngitis	23.5% 19/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	20.7% 17/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations Upper respiratory tract infection	14.8% 12/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	12.2% 10/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Infections and infestations Viral infection	6.2% 5/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	3.7% 3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Nervous system disorders Headache	16.0% 13/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	6.1% 5/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Respiratory, thoracic and mediastinal disorders Cough	7.4% 6/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	3.7% 3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Respiratory, thoracic and mediastinal disorders Throat irritation	6.2% 5/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	1.2% 1/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.
Skin and subcutaneous tissue disorders Urticaria	6.2% 5/81 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.	3.7% 3/82 • Adverse events were reported from first dose of study treatment until end of study treatment plus 16 weeks post treatment, up to a maximum duration of approximately 81 weeks.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER