Long-term Extension Study of Ligelizumab in Food Allergy

NCT05678959 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: CQGE031G12303B2022-502366-25-00
• Study Type: interventional
• Target: 163
• Locations: 9 countries
• Sites: 49

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.

Conditions

Food Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Percentage of Participants With TEAEs and TESAEs, Assessed in Participants With at Least One Home Administration of Study Drug

  Up to approximately 81 weeks

• Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Teenager Form (FAQLQ-TF)

  Up to approximately 97 weeks

• Change From Baseline in Total Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) Adult Form (FAQLQ-AF)

  Up to approximately 97 weeks

• Change From Baseline in Total Scores in the Food Allergy Independent Measure (FAIM) Teenager Form (FAIM-TF)

  Up to approximately 97 weeks

Study Arms (2)

Ligelizumab 120 mg

EXPERIMENTAL

Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.

Drug: Ligelizumab 120 mg

Ligelizumab 240 mg

EXPERIMENTAL

Participants received ligelizumab 240 mg every 4 weeks.

Drug: Ligelizumab 240 mg

Interventions

Ligelizumab 120 mg DRUG

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

Ligelizumab 120 mg

Ligelizumab 240 mg DRUG

2 injections of 1.0 mL ligelizumab every 4 weeks

Ligelizumab 240 mg

Eligibility Criteria

• Age: 6 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (49)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Allergy and Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Allergy and Asthma Associates of Santa Clara Vally Center

San Jose, California, 95117, United States

Location

Allergy and Asthma Clin Res Inc

Walnut Creek, California, 94598, United States

Location

UCHealth Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Asthma and Allergy Associates P C

Colorado Springs, Colorado, 80907, United States

Location

Univ of South Florida Asthma Allergy and Immunology CRU

Tampa, Florida, 33613, United States

Location

Childrens Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Atlanta Allergy and Asthma Clinic

Marietta, Georgia, 30062, United States

Location

Ann and Robert H Lurie Childs Hosp

Chicago, Illinois, 60611, United States

Location

Family Allergy and Asthma

Lousiville, Kentucky, 40217, United States

Location

Johns Hopkins Childrens Center

Baltimore, Maryland, 21287, United States

Location

Boston Childrens Hospital

Boston, Massachusetts, 02215, United States

Location

University of Michigan Clinical Trials Office

Ann Arbor, Michigan, 48109, United States

Location

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, 48197, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

Northwell Health

New York, New York, 10028, United States

Location

Mt Sinai Medical Center

New York, New York, 10029-6574, United States

Location

University Of NC At Chapel Hill

Chapel Hill, North Carolina, 27599 9500, United States

Location

Cincinnati Childrens Hospital MC

Cincinnati, Ohio, 45229-3039, United States

Location

Childrens Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Unv of TX Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

Seattle Allergy and Asthma Rsch

Seattle, Washington, 98115, United States

Location

Novartis Investigative Site

Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3052, Australia

Location

Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1Y 4G2, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M3B 3S6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1C5, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1V 4W2, Canada

Location

Novartis Investigative Site

Angers, France, 49933, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Frankfurt am Main, Hesse, 60590, Germany

Location

Novartis Investigative Site

Frankfurt am Main, Hesse, 60596, Germany

Location

Novartis Investigative Site

Dresden, Saxony, 01307, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0392, Japan

Location

Novartis Investigative Site

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Novartis Investigative Site

Utrecht, 3584 CX, Netherlands

Location

Novartis Investigative Site

Esplugues, Barcelona, 08950, Spain

Location

Novartis Investigative Site

Barcelona, 08036, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 38814736 DERIVED

Related Links

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

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 10, 2023
• Study Start: April 27, 2023
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: January 13, 2026
• Results First Posted: October 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); JP (2); ES (4); NL (1); CA (5); FR (4); IT (1); US (25); DE (4)