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

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502366-25-00

Acronym

CQGE031G12303B

Enrollment

Registered

2023-08-21

Start date

2023-09-11

Completion date

2025-02-14

Last updated

2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy

Brief summary

Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs

Detailed description

Proportion of participants tolerating a single dose of ≥ 600 mg of peanut protein without dose limiting symptoms during an open label OFC at scheduled timepoints, Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs, Summaries of total scores in the FAQLQ, FAIM and SF-36v2 by age and responder (participants and/or caregiver) at scheduled timepoints

Interventions

DRUG-

DRUGSALBUTAMOL

DRUGPCM001

DRUGEPINEPHRINE

DRUGplacebo to QGE031 120 mg/ mL solution for injection in pre-filled syringe

DRUGQGE031

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs	—

Secondary

Measure	Time frame
Proportion of participants tolerating a single dose of ≥ 600 mg of peanut protein without dose limiting symptoms during an open label OFC at scheduled timepoints, Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs, Summaries of total scores in the FAQLQ, FAIM and SF-36v2 by age and responder (participants and/or caregiver) at scheduled timepoints	—

Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026