Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Study Purpose
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.
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 |
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.
- - 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.
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 |
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
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Completed
Address
Novartis Investigative Site
Birmingham, Alabama, 35209
Status
Completed
Address
Novartis Investigative Site
Scottsdale, Arizona, 85251
Status
Completed
Address
Novartis Investigative Site
Little Rock, Arkansas, 72202
Status
Recruiting
Address
Novartis Investigative Site
Mission Viejo, California, 92691
Status
Completed
Address
Novartis Investigative Site
San Jose, California, 95117
Status
Completed
Address
Novartis Investigative Site
Walnut Creek, California, 94598
Status
Active, not recruiting
Address
Novartis Investigative Site
Aurora, Colorado, 80045
Status
Active, not recruiting
Address
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Status
Completed
Address
Novartis Investigative Site
Denver, Colorado, 80230
Status
Recruiting
Address
Novartis Investigative Site
Jacksonville, Florida, 32224
Status
Recruiting
Address
Novartis Investigative Site
Miami, Florida, 33136
Status
Recruiting
Address
Novartis Investigative Site
Saint Petersburg, Florida, 33701
Status
Completed
Address
Novartis Investigative Site
Tampa, Florida, 33613
Status
Completed
Address
Novartis Investigative Site
Atlanta, Georgia, 30342
Status
Completed
Address
Novartis Investigative Site
Marietta, Georgia, 30062
Status
Active, not recruiting
Address
Novartis Investigative Site
Chicago, Illinois, 60611
Status
Active, not recruiting
Address
Novartis Investigative Site
Indianapolis, Indiana, 46202
Status
Recruiting
Address
Novartis Investigative Site
Iowa City, Iowa, 52242
Status
Completed
Address
Novartis Investigative Site
Louisville, Kentucky, 40217
Status
Completed
Address
Novartis Investigative Site
Baltimore, Maryland, 21287
Status
Withdrawn
Address
Novartis Investigative Site
White Marsh, Maryland, 21162
Status
Active, not recruiting
Address
Novartis Investigative Site
Boston, Massachusetts, 02114
Status
Completed
Address
Novartis Investigative Site
Boston, Massachusetts, 02215
Status
Completed
Address
Novartis Investigative Site
Ann Arbor, Michigan, 48109-0922
Status
Active, not recruiting
Address
Novartis Investigative Site
Ypsilanti, Michigan, 48197
Status
Withdrawn
Address
Novartis Investigative Site
Ocean City, New Jersey, 07712
Status
Completed
Address
Novartis Investigative Site
Buffalo, New York, 14203
Status
Completed
Address
Novartis Investigative Site
New York, New York, 10028
Status
Active, not recruiting
Address
Novartis Investigative Site
New York, New York, 10029-6574
Status
Withdrawn
Address
Novartis Investigative Site
Rochester, New York, 14642
Status
Completed
Address
Novartis Investigative Site
Chapel Hill, North Carolina, 27599-9500
Status
Completed
Address
Novartis Investigative Site
Cincinnati, Ohio, 45229-3039
Status
Completed
Address
Novartis Investigative Site
Cincinnati, Ohio, 45231
Status
Completed
Address
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Status
Withdrawn
Address
Novartis Investigative Site
Memphis, Tennessee, 38103
Status
Completed
Address
Novartis Investigative Site
Dallas, Texas, 75235
Status
Active, not recruiting
Address
Novartis Investigative Site
Houston, Texas, 77030
Status
Completed
Address
Novartis Investigative Site
Seattle, Washington, 98115
International Sites
Status
Completed
Address
Novartis Investigative Site
Brisbane, Queensland, 4101
Status
Withdrawn
Address
Novartis Investigative Site
North Adelaide, South Australia, 5066
Status
Completed
Address
Novartis Investigative Site
Parkville, Victoria, 3052
Status
Completed
Address
Novartis Investigative Site
Nedlands, Western Australia, 6009
Status
Completed
Address
Novartis Investigative Site
Hamilton, Ontario, L8N 3Z5
Status
Completed
Address
Novartis Investigative Site
Ottawa, Ontario, K1Y 4G2
Status
Active, not recruiting
Address
Novartis Investigative Site
Toronto, Ontario, M3B 3S6
Status
Active, not recruiting
Address
Novartis Investigative Site
Montreal, Quebec, H3T 1C5
Status
Completed
Address
Novartis Investigative Site
Quebec, , G1V 4W2
Status
Completed
Address
Novartis Investigative Site
Odense, , 5000
Status
Completed
Address
Novartis Investigative Site
Angers Cedex 1, , 49033
Status
Completed
Address
Novartis Investigative Site
Lille, , 59000
Status
Withdrawn
Address
Novartis Investigative Site
Strasbourg Cedex, , 67091
Status
Completed
Address
Novartis Investigative Site
Toulouse, , 31400
Status
Completed
Address
Novartis Investigative Site
Vandoeuvre Les Nancy, , 54511
Status
Completed
Address
Novartis Investigative Site
Berlin, , 13353
Status
Withdrawn
Address
Novartis Investigative Site
Berlin, , 13353
Status
Completed
Address
Novartis Investigative Site
Dresden, , 01307
Status
Completed
Address
Novartis Investigative Site
Frankfurt, , 60590
Status
Completed
Address
Novartis Investigative Site
Frankfurt, , 60596
Status
Active, not recruiting
Address
Novartis Investigative Site
Padova, PD, 35128
Status
Withdrawn
Address
Novartis Investigative Site
Roma, RM, 00146
Status
Completed
Address
Novartis Investigative Site
Sagamihara-city, Kanagawa, 252-0392
Status
Withdrawn
Address
Novartis Investigative Site
Yokohama-city, Kanagawa, 231-8682
Status
Completed
Address
Novartis Investigative Site
Setagaya-ku, Tokyo, 157-8535
Status
Completed
Address
Novartis Investigative Site
Shinagawa-ku, Tokyo, 142-8666
Status
Active, not recruiting
Address
Novartis Investigative Site
Utrecht, , 3584CX
Status
Completed
Address
Novartis Investigative Site
Esplugues De Llobregat, Barcelona, 08950
Status
Withdrawn
Address
Novartis Investigative Site
Barcelona, Catalunya, 08035
Status
Active, not recruiting
Address
Novartis Investigative Site
Barcelona, Catalunya, 08036
Status
Completed
Address
Novartis Investigative Site
Madrid, , 28009
Status
Completed
Address
Novartis Investigative Site
Madrid, , 28040
Status
Withdrawn
Address
Novartis Investigative Site
London, , W2 1NY
Status
Withdrawn
Address
Novartis Investigative Site
Manchester, , M23 9LT
Status
Withdrawn
Address
Novartis Investigative Site
Southampton, , SO16 6YD