Last Update: May 14, 2024
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CQGE031G12303B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

Participants will receive up to 3 years treatment with ligelizumab after which they will enter a follow-up period for 16 weeks. During the study, participants will undergo allergy testing by a Skin Prick Test and Oral Food challenge to test if the treatment is working or not. Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic patients in terms of safety, efficacy, pharmaco-dynamics, biomarkers and Qualify of Life, and potential discontinuation from treatment.

During the study, treatment will be administered every 4 weeks and while this can take place in the hospital clinic, some participants will be trained to administer study treatment at home by either the participant or parent/caregiver. Participants at home will record administration of the study treatment on a dosing log and return this to the clinic for review.

Food Allergy
Phase 3
Recruiting
550
Apr 27, 2023
Jul 06, 2027
All
6 Years - 57 Years (Child, Adult)

Interventions

Drug

Ligelizumab 120 mg

1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo
Drug

Ligelizumab 240 mg

2 injections of 1.0 mL ligelizumab

Eligibility Criteria

Inclusion Criteria:

Signed informed consent and assent form (where applicable)
Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
Participants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challenge
Participants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the study
Participants are able to safety continue into the study as judged by the investigator

Exclusion Criteria:

Development of a severe or life threatening episode of an allergic reaction that required intubation and/or Intensive Care Unit admission during the core studies
Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studies
Development of uncontrolled asthma during the core study that could compromise the safety of 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 duringthe core study, and in the Investigator's opinion they should not participate in this extension study
Platelets <75,000/ul at end of treatment of the core study

Other protocol defined inclusion/exclusion criteria may apply

Study Location

Novartis Investigative Site

Recruiting

Toulouse,31400,France

Novartis Investigative Site

Recruiting

Lille,59000,France

Novartis Investigative Site

Recruiting

Angers,49033,France

Novartis Investigative Site

Recruiting

Berlin,13353,Germany

Novartis Investigative Site

Recruiting

Dresden,01307,Germany

Novartis Investigative Site

Recruiting

Frankfurt,60590,Germany

Novartis Investigative Site

Recruiting

Frankfurt,60596,Germany

Novartis Investigative Site

Recruiting

Padova,PD,35128,Italy

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08036,Spain

Allervie Clinical Research

Recruiting

Birmingham,(205-871-9661) -- Weily Soong,35209 - Alabama,United States

UCHealth Outpatient Pavilion .

Recruiting

Aurora,Christine Stewart email: [email protected] -- Matthew Jason Greenhawt,80045 - Colorado,United States

Asthma and Allergy Associates P C

Recruiting

Colorado Springs,Lidia Bayne (719-473-8330) email: [email protected] -- Daniel Soteres,80907 - Colorado,United States

Mt Sinai Medical Center

Recruiting

New York,Tracy Lo (212-659-5596) email: [email protected] -- Amanda Cox,10029-6574 - New York,United States

Northwell Health Main Center

Recruiting

New York,Aaqil Ali (516-622-5070) email: [email protected] -- Punita Ponda,10028 - New York,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals