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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984876
Recruitment Status : Recruiting
First Posted : August 2, 2021
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Allergy, Peanut Drug: ligelizumab Drug: Placebo Phase 3

Detailed 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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 7, 2021
Estimated Primary Completion Date : January 28, 2025
Estimated Study Completion Date : May 21, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: ligelizumab 240 mg
ligelizumab 240 mg subcutaneous injection for 52 weeks
Drug: ligelizumab
Subcutaneous injection once every 4 weeks

Experimental: ligelizumab 120 mg
ligelizumab 120 mg subcutaneous injection for 52 weeks
Drug: ligelizumab
Subcutaneous injection once every 4 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
Drug: ligelizumab
Subcutaneous injection once every 4 weeks

Drug: Placebo
Subcutaneous injection once every 4 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
Drug: ligelizumab
Subcutaneous injection once every 4 weeks

Drug: Placebo
Subcutaneous injection once every 4 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
Drug: ligelizumab
Subcutaneous injection once every 4 weeks

Drug: Placebo
Subcutaneous injection once every 4 weeks




Primary Outcome Measures :
  1. Proportion of participants who can tolerate a single dose of ≥ 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [ Time Frame: Week 12 ]
    Responder status is defined as 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


Secondary Outcome Measures :
  1. Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [ Time Frame: Week 12 ]
    Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12

  2. Proportion of participants who can tolerate a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12 [ Time Frame: Week 12 ]
    Responder status is defined as tolerating a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the DBPCFC conducted at Week 12

  3. Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12 [ Time Frame: Week 12 ]
    Maximum severity of symptoms will be assessed during the DBPCFC conducted at Week 12. Symptom severity will be categorized as 4 levels: None, Mild, Moderate, Severe

  4. Proportion of participants who can tolerate a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 52 [ Time Frame: Week 52 ]
    Responder status is defined as tolerating a single dose of ≥ 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during DBPCFC conducted at Week 52

  5. Change in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 52 compared to Week 12 [ Time Frame: Week 12 and Week 52 ]
    Change in MTD of peanut protein without dose-limiting symptoms at Week 52 compared to Week 12. 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.

  6. Change from baseline in peanut-specific IgE at Week 12, Week 16 and Week 52 [ Time Frame: Baseline, Week 12, 16 and 52 ]
    Change from baseline of serum levels of peanut-specific immunoglobulin E (IgE)

  7. Change from baseline in peanut-specific IgG4 at Week 12, Week 16 and 52 [ Time Frame: Baseline, Week 12, 16 and 52 ]
    Change from baseline of serum levels of peanut-specific immunoglobulin G4 (IgG4)

  8. Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68 [ Time Frame: Baseline, Week 16, 56 and 68 ]
    Change from baseline (screening) in skin prick test (SPT) mean wheal diameters.

  9. Change from baseline in total and domain scores in the FAQLQ by age and responder (subject and/or caregiver) [ Time Frame: Baseline, Week 12 and 56 ]
    The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Quality of Life Questionnaire (FAQLQ)

  10. Change from baseline in total and domain scores in the FAIM by age and responder (subject and/or caregiver) [ Time Frame: Baseline, Week 12 and 56 ]
    The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by Food Allergy Independent Measure (FAIM).

  11. Change from baseline in total and domain scores in the SF-36v2 by age and responder (subject and/or caregiver) [ Time Frame: Baseline, Week 12 and 56 ]
    The impact of ligelizumab on the health-related quality of life (HRQoL) of participants with a food allergy will be assessed by a Medical Outcomes Study 36-Item Short Form Version 2 (SF-36v2).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984876


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Alabama
Novartis Investigative Site Recruiting
Birmingham, Alabama, United States, 35209
United States, Arizona
Novartis Investigative Site Recruiting
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Novartis Investigative Site Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Novartis Investigative Site Recruiting
Mission Viejo, California, United States, 92691
Novartis Investigative Site Recruiting
San Jose, California, United States, 95117
Novartis Investigative Site Recruiting
Walnut Creek, California, United States, 94598
United States, Colorado
Novartis Investigative Site Recruiting
Colorado Springs, Colorado, United States, 80907
Novartis Investigative Site Recruiting
Denver, Colorado, United States, 80230
United States, Florida
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Novartis Investigative Site Recruiting
Atlanta, Georgia, United States, 30342
Novartis Investigative Site Recruiting
Marietta, Georgia, United States, 30062
United States, Kentucky
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40215
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21287
Novartis Investigative Site Recruiting
White Marsh, Maryland, United States, 21162
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Novartis Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48109-0922
Novartis Investigative Site Recruiting
Ypsilanti, Michigan, United States, 48197
United States, New Jersey
Novartis Investigative Site Recruiting
Ocean City, New Jersey, United States, 07712
United States, New York
Novartis Investigative Site Recruiting
Buffalo, New York, United States, 14203
Novartis Investigative Site Recruiting
New York, New York, United States, 10028
Novartis Investigative Site Recruiting
New York, New York, United States, 10029-6574
Novartis Investigative Site Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Novartis Investigative Site Recruiting
Chapel Hill, North Carolina, United States, 27599-9500
United States, Ohio
Novartis Investigative Site Recruiting
Cincinnati, Ohio, United States, 45229-3039
Novartis Investigative Site Recruiting
Cincinnati, Ohio, United States, 45231
United States, Tennessee
Novartis Investigative Site Recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
United States, Washington
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98115
Australia, Victoria
Novartis Investigative Site Recruiting
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Novartis Investigative Site Recruiting
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Novartis Investigative Site Recruiting
Ottawa, Ontario, Canada, K1Y 4G2
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M3B 3S6
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3T 1C5
Canada
Novartis Investigative Site Recruiting
Quebec, Canada, G1V 4W2
France
Novartis Investigative Site Recruiting
Angers Cedex 1, France, 49033
Novartis Investigative Site Recruiting
Toulouse, France, 31400
Novartis Investigative Site Recruiting
Vandoeuvre Les Nancy, France, 54511
Italy
Novartis Investigative Site Recruiting
Padova, PD, Italy, 35128
Japan
Novartis Investigative Site Recruiting
Sagamihara-city, Kanagawa, Japan, 252-0392
Novartis Investigative Site Recruiting
Setagaya-ku, Tokyo, Japan, 157-8535
Novartis Investigative Site Recruiting
Shinagawa-ku, Tokyo, Japan, 142-8666
Netherlands
Novartis Investigative Site Recruiting
Utrecht, Netherlands, 3584CX
Spain
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04984876    
Other Study ID Numbers: CQGE031G12301
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: June 28, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Food allergy
Peanut allergy
Oral food challenge
IgE
ligelizumab
Additional relevant MeSH terms:
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Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate