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

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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.

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04984876
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy, Peanut

Additional Details

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. Participants will be randomized to ligelizumab 240 mg, ligelizumab 120 mg, or placebo (5 treatment arms, randomization ratio of 2:2:2:2:1) for the double-blind placebo-controlled treatment period (up to Week 12). Participants initially assigned to the 8-week placebo arms will receive the first dose of blinded ligelizumab treatment at the Week 8 visit. Participants initially assigned to the 16-week placebo arm will receive the last dose of placebo before the double blind placebo controlled food challenge (DBPCFC) at week 12 and the first dose of blinded ligelizumab treatment at the Week 16 visit.

Arms & Interventions

Arms

Experimental: ligelizumab 240 mg

ligelizumab 240 mg subcutaneous injection for 52 weeks

Experimental: ligelizumab 120 mg

ligelizumab 120 mg subcutaneous injection for 52 weeks

Experimental: Placebo 8 weeks and ligelizumab 120 mg

Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

Experimental: Placebo 16 weeks and ligelizumab 120 mg/240 mg

Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

Experimental: Placebo 8 weeks and ligelizumab 240 mg

Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks

Interventions

Drug: - ligelizumab

Subcutaneous injection once every 4 weeks

Drug: - Placebo

Subcutaneous injection once every 4 weeks

Contact a Trial Team

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Novartis Investigative Site, Birmingham, Alabama

Status

Completed

Address

Novartis Investigative Site

Birmingham, Alabama, 35209

Site Contact

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