Long-term Extension Study of Ligelizumab in Food Allergy

Novartis

Status and phase: Terminated; Phase 3

Conditions: Food Allergy

Treatments: Drug: Ligelizumab 120 mg; Drug: Ligelizumab 240 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05678959

2022-502366-25-00 (EU Trial (CTIS) Number)

CQGE031G12303B

Details and patient eligibility

About

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

Full description

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.

Enrollment: 163 patients

Sex: All

Ages: 6 to 57 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
• Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
• Participants who are 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 agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study
• Participants who are able to safely continue into the study as judged by the investigator

Key Exclusion Criteria:

• Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or ICU 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 study
• Development of uncontrolled asthma during the core study that could compromise 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 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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163 participants in 2 patient groups

Ligelizumab 120 mg

Experimental group

Description:

120 mg

Treatment:

Drug: Ligelizumab 120 mg

Ligelizumab 240 mg

Experimental group

Description:

240 mg

Treatment:

Drug: Ligelizumab 240 mg