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

A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy

ClinicalTrials.gov Identifier: NCT04984876

Novartis Reference Number: CQGE031G12301

Last Update: May 20, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Allergy, Peanut

Phase

Phase 3

Overall status

Recruiting

Start date

Dec 07, 2021

Completion date

May 27, 2025

Gender

All

Age(s)

6 Years - 55 Years (Child, Adult)

Interventions

Drug

ligelizumab

Subcutaneous injection once every 4 weeks

Drug

Placebo

Subcutaneous injection once every 4 weeks

Eligibility 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), ≥ 0.35 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.