Long-term Extension Study of Ligelizumab in Food Allergy

A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05678959

Enrollment

163

Registered

2023-01-10

Start date

2023-04-27

Completion date

2025-03-06

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

Keywords

Food allergy, Peanut allergy, Oral food challenge (OFC), Immunoglobulin E (IgE), ligelizumab

Brief summary

This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.

Detailed description

This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III core studies to roll over to this extension study once the participants had completed predefined minimal requirements of a core study and agreed to consent to participate in this study. Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness. A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.

Interventions

DRUGLigelizumab 120 mg

1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks

DRUGLigelizumab 240 mg

2 injections of 1.0 mL ligelizumab every 4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 57 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit. * Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy. * Participants who were willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge). * Participants who agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study. * Participants who were able to safely continue into the study as judged by the investigator. Key

Exclusion criteria

* Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies. * Development of a serious adverse event which was suspected to be related to the study treatment judged by the investigator during the core study. * Development of uncontrolled asthma during the core study that compromised the safety of the participants judged by the investigator. * Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator. * Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion, should not participate in this extension study. * Platelets \<75,000/ul at end of treatment of the core study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	Up to approximately 81 weeks	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug	Up to approximately 81 weeks	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.
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)	Up to approximately 97 weeks	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.
Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)	Up to approximately 97 weeks	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.
Number of Participants Tolerating a Single Dose of More Than or Equal to 600 mg of Peanut Protein Without Dose-Limiting Symptoms	Up to approximately 97 weeks	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.
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Adult Form (FAIM-AF)	Up to approximately 97 weeks	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.
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)	Up to approximately 97 weeks	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.
Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)	Up to approximately 97 weeks	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.

Countries

Australia, Canada, France, Germany, Italy, Japan, Netherlands, Spain, United States

Participant flow

Pre-assignment details

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

Participants by arm

Arm	Count
Ligelizumab 120 mg Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	81
Ligelizumab 240 mg Participants received ligelizumab 240 mg every 4 weeks.	82
Total	163

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	1
Overall Study	Guardian Decision	1	0
Overall Study	Physician Decision	2	3
Overall Study	Protocol Deviation	0	1
Overall Study	Study Terminated by Sponsor	76	76
Overall Study	Subject Decision	1	0
Overall Study	Technical Problem	0	1

Baseline characteristics

Characteristic	Ligelizumab 120 mg	Ligelizumab 240 mg	Total
Age, Continuous	19.4 years STANDARD_DEVIATION 6.95	18.9 years STANDARD_DEVIATION 6.23	19.2 years STANDARD_DEVIATION 6.58
Age, Customized 12 - 17 years	41 participants	46 participants	87 participants
Age, Customized 18 - 55 years	40 participants	36 participants	76 participants
Race/Ethnicity, Customized Asian	12 participants	10 participants	22 participants
Race/Ethnicity, Customized Black or African American	4 participants	4 participants	8 participants
Race/Ethnicity, Customized Multiple	1 participants	1 participants	2 participants
Race/Ethnicity, Customized Not Reported	6 participants	6 participants	12 participants
Race/Ethnicity, Customized White	58 participants	61 participants	119 participants
Sex: Female, Male Female	37 Participants	36 Participants	73 Participants
Sex: Female, Male Male	44 Participants	46 Participants	90 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 81	0 / 82
other Total, other adverse events	47 / 81	43 / 82
serious Total, serious adverse events	3 / 81	2 / 82

Outcome results

Primary

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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

Time frame: 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.

Arm	Measure	Group	Value (NUMBER)
Ligelizumab 120 mg	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TEAEs	84.0 percentage of participants
Ligelizumab 120 mg	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TESAEs	3.7 percentage of participants
Ligelizumab 240 mg	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TEAEs	69.5 percentage of participants
Ligelizumab 240 mg	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	TESAEs	2.4 percentage of participants

Secondary

Change From Baseline in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF-36v2) Physical Component Score (PCS) and Mental Component Score (MCS)

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