Long-term Extension Study of Ligelizumab in Food Allergy

Food Allergy Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

• NCT number: NCT05678959
• Study type: Interventional
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email@novartis.com
• Status: Recruiting
• Phase: Phase 3
• Start date: April 27, 2023
• Completion date: July 6, 2027