For Healthcare Professionals

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


About the study

This is 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) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Male or female participants who are ≥ 6 and ≤ 55 years of age at the time of signing informed consent/assent.
  2. Documented medical history of allergy to peanuts or peanut-containing foods.
  3. Positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 0.35 kUA/L at Screening visit 1 (Screening 1).
  4. Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to saline control.
  5. A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
  6. Participants must weigh ≥ 20 kg at Screening 1.


Exclusion Criteria:

  1. Total IgE >2000 IU/mL at Screening 1.
  2. History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).
  3. Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria:
  4. FEV1 <80% of subject's predicted normal value at Screening visit 1
  5. One hospitalization for asthma within 12 months prior to Screening visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Allergy, Peanut

Age (in years)

6 - 55


Phase 3

Participants needed


Est. Completion Date

May 21, 2025

Treatment type



Novartis identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.