Long-term Extension Study of Ligelizumab in Food Allergy

Last Update: Apr 18, 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:

NCT05678959

Novartis Reference Number:CQGE031G12303B

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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.

Condition

Food Allergy

Phase

Phase 3

Overall Status

Recruiting

Number of Participants

550

Start Date

Apr 27, 2023

Completion Date

Jun 07, 2027

Gender

All

Age(s)

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

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Novartis Pharmaceuticals

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Long-term Extension Study of Ligelizumab in Food Allergy

Study Description

Interventions

Ligelizumab 120 mg

Ligelizumab 240 mg

Eligibility Criteria

Study Location

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Uni of TX SW Med Ctr

Cincinnati Childrens Hospital MC .

Allervie Clinical Research

Univ of South Florida Asthma Allergy and Immunology CRU

Family Allergy and Asthma

Ann and Robert H Lurie Childrens Hospital of Chicago .

University of Michigan Medical Ctr

Mt Sinai Medical Center

Respiratory Medicine Research Institute of Michigan

Arkansas Children's Hospital

Northwell Health Main Center

Texas Childrens Hospital

Asthma and Allergy Associates P C

UBMD Pediatrics

Boston Childrens Hospital

Novartis Investigative Site

UCHealth Outpatient Pavilion .

Children's Hospital of Philadelphia

Allergy and Immunology Associates

Worldwide Contacts

Novartis Pharmaceuticals

Novartis Pharmaceuticals

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