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

• Status: Not yet recruiting
• Trial end date: 2025-05-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male or female participants who are ≥ 6 and ≤ 55 years of age at the time of signing informed consent/assent.

• Documented medical history of allergy to peanuts or peanut-containing foods.

• Positive peanut-specific immunoglobulin E (peanut sIgE), ≥ 6 kUA/L at Screening visit 1 (Screening 1).

• 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.

• 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, and no occurrence on placebo. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.

• Participants must weigh ≥ 20 kg at Screening 1.

Exclusion Criteria:

• Total IgE >2000 IU/mL at Screening 1.

• History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).

• Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria:

• FEV1 <80% of subject's predicted normal value at Screening visit 1

• One hospitalization for asthma within 12 months prior to Screening visit 1

Other protocol-defined inclusion/exclusion criteria may apply.