Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Allergy, Peanut
In brief
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.
Key facts
- Study ID
- NCT04984876
- Run by
- Novartis Pharmaceuticals
- People needed
- 211
- Starts
- 2021-12-07
- Expected to finish
- 2023-11-27
- Last updated by the study team
- 2025-04-29
Who can join
Age: 6 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Allergy and Immunology Associates — Scottsdale, Arizona, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Allergy and Asthma Associates of Santa Clara Vally Center — San Jose, California, United States
- Allergy and Asthma Clinical Research Inc — Walnut Creek, California, United States
- UCHealth Outpatient Pavilion — Aurora, Colorado, United States
- Asthma and Allergy Associates P C — Colorado Springs, Colorado, United States
- Colorado Allergy and Asthma Ctr PC — Denver, Colorado, United States
- Univ of South Florida Asthma Allergy and Immunology CRU — Tampa, Florida, United States
- Childrens Healthcare of Atlanta — Atlanta, Georgia, United States
- Atlanta Allergy and Asthma Clinic — Marietta, Georgia, United States
- Ann and Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Family Allergy and Asthma — Louisville, Kentucky, United States
- Johns Hopkins Childrens Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Childrens Hospital — Boston, Massachusetts, United States
- University of Michigan Clinical Trials Office — Ann Arbor, Michigan, United States
- Respiratory Medicine Research Institute of Michigan — Ypsilanti, Michigan, United States
- UBMD Pediatrics — Buffalo, New York, United States
- Northwell Health — New York, New York, United States
- Mt Sinai Medical Center — New York, New York, United States
- University Of NC At Chapel Hill — Chapel Hill, North Carolina, United States
- Cincinnati Childrens Hospital MC — Cincinnati, Ohio, United States
- Bernstein Clinical Research Center — Cincinnati, Ohio, United States
- Allervie Clinical Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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