NCT05678959

Long-term Extension Study of Ligelizumab in Food Allergy

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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 163 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 57 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study. Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness. A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DRUG	Ligelizumab 120 mg	1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo every 4 weeks
DRUG	Ligelizumab 240 mg	2 injections of 1.0 mL ligelizumab every 4 weeks

Timeline

• Start date: 2023-04-27
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2023-01-10
• Last updated: 2026-01-13
• Results posted: 2025-10-30

Locations

49 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, Japan, Netherlands, Spain

Regulatory

• FDA-regulated drug study