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

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.

Study Overview

• Status: Terminated
• Conditions: Food Allergy
• Intervention / Treatment: Drug: Ligelizumab 120 mg; Drug: Ligelizumab 240 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4101
      • Novartis Investigative Site
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Novartis Investigative Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Novartis Investigative Site
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Novartis Investigative Site
    • Ottawa, Ontario, Canada, K1Y 4G2
      • Novartis Investigative Site
    • Toronto, Ontario, Canada, M3B 3S6
      • Novartis Investigative Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Novartis Investigative Site
    • Québec, Quebec, Canada, G1V 4W2
      • Novartis Investigative Site
• France
  • Lille, France, 59000
    • Novartis Investigative Site
  • Toulouse, France, 31400
    • Novartis Investigative Site
  • Vandœuvre-lès-Nancy, France, 54511
    • Novartis Investigative Site
  • France
    • Angers, France, France, 49933
      • Novartis Investigative Site
• Germany
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Novartis Investigative Site
    • Frankfurt am Main, Hesse, Germany, 60596
      • Novartis Investigative Site
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Novartis Investigative Site
• Italy
  • PD
    • Padua, PD, Italy, 35128
      • Novartis Investigative Site
• Japan
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0392
      • Novartis Investigative Site
  • Tokyo
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • Novartis Investigative Site
• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08036
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Madrid, Spain, 28009
    • Novartis Investigative Site
  • Barcelona
    • Esplugues, Barcelona, Spain, 08950
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • AllerVie Clinical Research
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Allergy and Immunology Associates
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • San Jose, California, United States, 95117
      • Allergy and Asthma Associates of Santa Clara Vally Center
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clin Res Inc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth Outpatient Pavilion
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates P C
  • Florida
    • Tampa, Florida, United States, 33613
      • Univ of South Florida Asthma Allergy and Immunology CRU
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Childrens Healthcare of Atlanta
    • Marietta, Georgia, United States, 30062
      • Atlanta Allergy and Asthma Clinic
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann and Robert H Lurie Childs Hosp
  • Kentucky
    • Lousiville, Kentucky, United States, 40217
      • Family Allergy and Asthma
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Childrens Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston Childrens Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Clinical Trials Office
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan
  • New York
    • Buffalo, New York, United States, 14203
      • UBMD Pediatrics
    • New York, New York, United States, 10029-6574
      • Mt Sinai Medical Center
    • New York, New York, United States, 10028
      • Northwell Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599 9500
      • University Of NC At Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Childrens Hospital MC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Childrens Hospital of Philadelphia
  • Texas
    • Dallas, Texas, United States, 75235
      • Unv of TX Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Texas Childrens Hospital
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Allergy and Asthma Rsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 57 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ligelizumab 120 mg; Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.	Drug: Ligelizumab 120 mg; 1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks
Experimental: Ligelizumab 240 mg; Participants received ligelizumab 240 mg every 4 weeks.	Drug: Ligelizumab 240 mg; 2 injections of 1.0 mL ligelizumab every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 81 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.

Helpful Links

• A Plain Language Trial Summary is available on www.novctrd.com
• A Pediatric Plain Language Trial Summary is available on www.novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Peanut allergy; Food allergy; ligelizumab; Immunoglobulin E (IgE); Oral food challenge (OFC)
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity; Immunologic Factors; Physiological Effects of Drugs; ligelizumab
• Other Study ID Numbers: CQGE031G12303B; 2022-502366-25-00 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No