Long-term Extension Study of Ligelizumab in Food Allergy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 57 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05678959
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, France, Germany, Italy, Japan, Netherlands, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Experimental: Ligelizumab 120 mg

120 mg

Experimental: Ligelizumab 240 mg

240 mg

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allervie Clinical Research, Birmingham, Alabama

Status

Active, not recruiting

Address

Allervie Clinical Research

Birmingham, Alabama, 35209

Site Contact

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