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Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy

NCT04984876 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2025-04-29

Study results available
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Summary

This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.

Conditions

  • Allergy, Peanut

Interventions

DRUG

ligelizumab

Subcutaneous injection once every 4 weeks

DRUG

Placebo

Subcutaneous injection once every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2023-11-27
Completion
2023-11-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984876 on ClinicalTrials.gov