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

NCT04984876 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: CQGE031G123012020-005339-56EMEA-001811-PIP03-20
• Study Type: interventional
• Target: 211
• Locations: 10 countries
• Sites: 55

Brief Summary

This was 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) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.

Conditions

Allergy, Peanut

Keywords

Food allergy; Peanut allergy; Oral food challenge; IgE; ligelizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12

  Responder rate was defined as the percentage of participants tolerating a single dose of \>= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12. The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms. Participants with treatment discontinuation or missing more than 1 doses of study drug prior to Week 12 due to reasons other than operational complications caused by public health emergency were considered non-responders.

  Week 12

Secondary Outcomes (14)

• Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12

  Week 12

• Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12

  Week 12

• Percentage of Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000 mg at Week 12

  Week 12

• Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12 After 4 Weeks of Treatment

  Week 12

• Percentage of Participants Who Tolerated the Specified Peanut Protein Dose Without Dose-limiting Symptoms at Week 52

  Week 52

Study Arms (5)

ligelizumab 240 mg

EXPERIMENTAL

ligelizumab 240 mg subcutaneous injection for 52 weeks

Drug: ligelizumab

ligelizumab 120 mg

EXPERIMENTAL

ligelizumab 120 mg subcutaneous injection for 52 weeks

Drug: ligelizumab

Placebo 8 weeks and ligelizumab 120 mg

EXPERIMENTAL

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

Drug: ligelizumab; Drug: Placebo

Placebo 16 weeks and ligelizumab 120 mg/240 mg

EXPERIMENTAL

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

Drug: ligelizumab; Drug: Placebo

Placebo 8 weeks and ligelizumab 240 mg

EXPERIMENTAL

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

Drug: ligelizumab; Drug: Placebo

Interventions

ligelizumab DRUG

Subcutaneous injection once every 4 weeks

Placebo 16 weeks and ligelizumab 120 mg/240 mg; Placebo 8 weeks and ligelizumab 120 mg; Placebo 8 weeks and ligelizumab 240 mg; ligelizumab 120 mg; ligelizumab 240 mg

Placebo DRUG

Subcutaneous injection once every 4 weeks

Placebo 16 weeks and ligelizumab 120 mg/240 mg; Placebo 8 weeks and ligelizumab 120 mg; Placebo 8 weeks and ligelizumab 240 mg

Eligibility Criteria

• Age: 6 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent and/or assent (where applicable) was obtained prior to study participation. Participant (and parent/legal guardian) was able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she was re-consented (ICF) at the next study visit.
• Male or female participants who were 6 to 55 yrs of age at the time of signing informed consent/assent.
• Documented medical history of allergy to peanuts or peanut-containing foods.
• Positive peanut-specific IgE (peanut sIgE), ≥ 0.35 kUA/L at Screening Visit 1.
• Positive SPT for peanut allergen at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control.

You may not qualify if:

• Participants must weigh ≥ 20 kg at Screening Visit 1.
• Participants must be able to receive injections (study treatment), participate in the DBPCFC, and must be willing to continue avoiding exposure to peanuts and any other foods that they are allergic to throughout this study.
• History of hypersensitivity to ligelizumab or its excipients, or to other biologics (i.e., to murine, chimeric or human antibodies).
• Hypersensitivity or intolerance to any of the matrix components used within the material for the oral food challenge.
• History of severe or life-threatening hypersensitivity event needing an ICU (intensive care unit) admission or intubation within 60 days prior to baseline DBPCFC (Screening Visit 2).
• Total IgE \>2000 IU/mL at Screening Visit 1.
• Participants with uncontrolled asthma (according to Global Initiative for Asthma (GINA) guidelines, GINA 2020) who meet any of the following criteria:
• FEV1 \<80% of participant's predicted normal value at Screening Visit 1
• One hospitalization for asthma within 12 months prior to Screening Visit 1
• Current or previous history of a mast cell disorder, including mastocytosis.
• Platelets \< 100'000/μL at Screening Visit 1.
• Female participants not on oral contraception with a stable dose for a minimum of 3 months prior to taking study treatment.
• Participants with evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines at Screening Visit 1 (before start of Screening Visit 2). If stool testing is positive for pathogenic organisms, the participant should not be randomized and should not be allowed to be rescreened.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (55)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Allergy and Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Allergy and Asthma Associates of Santa Clara Vally Center

San Jose, California, 95117, United States

Location

Allergy and Asthma Clinical Research Inc

Walnut Creek, California, 94598, United States

Location

UCHealth Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Asthma and Allergy Associates P C

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Ctr PC

Denver, Colorado, 80230, United States

Location

Univ of South Florida Asthma Allergy and Immunology CRU

Tampa, Florida, 33613, United States

Location

Childrens Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Atlanta Allergy and Asthma Clinic

Marietta, Georgia, 30062, United States

Location

Ann and Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Family Allergy and Asthma

Louisville, Kentucky, 40217, United States

Location

Johns Hopkins Childrens Center

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Childrens Hospital

Boston, Massachusetts, 02215, United States

Location

University of Michigan Clinical Trials Office

Ann Arbor, Michigan, 48109, United States

Location

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, 48197, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

Northwell Health

New York, New York, 10028, United States

Location

Mt Sinai Medical Center

New York, New York, 10029-6574, United States

Location

University Of NC At Chapel Hill

Chapel Hill, North Carolina, 27599 9500, United States

Location

Cincinnati Childrens Hospital MC

Cincinnati, Ohio, 45229-3039, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

Location

Childrens Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

Seattle Allergy and Asthma Rsch

Seattle, Washington, 98115, United States

Location

Novartis Investigative Site

Brisbane, Queensland, 4101, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3052, Australia

Location

Novartis Investigative Site

Nedlands, Western Australia, 6009, Australia

Location

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1Y 4G2, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M3B 3S6, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1C5, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1V 4W2, Canada

Location

Novartis Investigative Site

Odense, 5000, Denmark

Location

Novartis Investigative Site

Angers, 49933, France

Location

Novartis Investigative Site

Lille, 59000, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 252-0392, Japan

Location

Novartis Investigative Site

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Novartis Investigative Site

Utrecht, 3584CX, Netherlands

Location

Novartis Investigative Site

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 2, 2021
• Study Start: December 7, 2021
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: April 29, 2025
• Results First Posted: October 8, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (4); DE (4); IT (1); JP (3); NL (1); US (29); CA (5); DK (1); ES (4); AU (3)