Long-term Extension Study of Ligelizumab in Food Allergy
NCT ID: NCT05678959
Last Updated: 2026-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
163 participants
INTERVENTIONAL
2023-04-27
2025-03-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ligelizumab 120 mg
Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 weeks.
Ligelizumab 120 mg
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks
Ligelizumab 240 mg
Participants received ligelizumab 240 mg every 4 weeks.
Ligelizumab 240 mg
2 injections of 1.0 mL ligelizumab every 4 weeks
Interventions
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Ligelizumab 120 mg
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks
Ligelizumab 240 mg
2 injections of 1.0 mL ligelizumab every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
6 Years
57 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Allervie Clinical Research
Birmingham, Alabama, United States
Allergy and Immunology Associates
Scottsdale, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Allergy and Asthma Associates of Santa Clara Vally Center
San Jose, California, United States
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States
UCHealth Outpatient Pavilion
Aurora, Colorado, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
Atlanta Allergy and Asthma Clinic
Marietta, Georgia, United States
Ann and Robert H Lurie Childs Hosp
Chicago, Illinois, United States
Family Allergy and Asthma
Lousiville, Kentucky, United States
Johns Hopkins Childrens Center
Baltimore, Maryland, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
UBMD Pediatrics
Buffalo, New York, United States
Northwell Health
New York, New York, United States
Mt Sinai Medical Center
New York, New York, United States
University Of NC At Chapel Hill
Chapel Hill, North Carolina, United States
Cincinnati Childrens Hospital MC
Cincinnati, Ohio, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Unv of TX Southwestern Medical Center
Dallas, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States
Novartis Investigative Site
Brisbane, Queensland, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Angers, France, France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Vandœuvre-lès-Nancy, , France
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Esplugues, Barcelona, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
A Pediatric Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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2022-502366-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CQGE031G12303B
Identifier Type: -
Identifier Source: org_study_id
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