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

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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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Scottsdale, 85251
Arizona
United States
Novartis Investigative Site
Recruiting
Little Rock, 72202
Arkansas
United States
Novartis Investigative Site
Recruiting
Mission Viejo, 92691
California
United States
Novartis Investigative Site
Recruiting
San Jose, 95117
California
United States
Novartis Investigative Site
Recruiting
Colorado Springs, 80907
Colorado
United States
Novartis Investigative Site
Recruiting
Denver, 80230
Colorado
United States
Novartis Investigative Site
Recruiting
Atlanta, 30342
Georgia
United States
Novartis Investigative Site
Recruiting
Marietta, 30062
Georgia
United States
Novartis Investigative Site
Recruiting
Louisville, 40215
Kentucky
United States
Novartis Investigative Site
Recruiting
Baltimore, 21287
Maryland
United States
Novartis Investigative Site
Recruiting
White Marsh, 21162
Maryland
United States
Novartis Investigative Site
Recruiting
Boston, 02215
Massachusetts
United States
Novartis Investigative Site
Recruiting
Ann Arbor, 48109-0922
Michigan
United States
Novartis Investigative Site
Recruiting
Ypsilanti, 48197
Michigan
United States
Novartis Investigative Site
Recruiting
Ocean City, 07712
New Jersey
United States
Novartis Investigative Site
Recruiting
Buffalo, 14203
New York
United States
Novartis Investigative Site
Recruiting
New York, 10028
New York
United States
Novartis Investigative Site
Recruiting
New York, 10029-6574
New York
United States
Novartis Investigative Site
Recruiting
Chapel Hill, 27599-9500
North Carolina
United States
Novartis Investigative Site
Recruiting
Cincinnati, 45231
Ohio
United States
Novartis Investigative Site
Recruiting
Memphis, 38103
Tennessee
United States
Novartis Investigative Site
Recruiting
Seattle, 98115
Washington
United States
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Canada
Novartis Investigative Site
Recruiting
Ottawa, K1Y 4G2
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M3B 3S6
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1C5
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1V 4W2
-
Canada
France
Novartis Investigative Site
Recruiting
Vandoeuvre Les Nancy, 54511
-
France
Japan
Novartis Investigative Site
Recruiting
Sagamihara-city, 252-0392
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Setagaya-ku, 157-8535
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinagawa-ku, 142-8666
Tokyo
Japan
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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