Long-term Extension Study of Ligelizumab in Food Allergy

Last updated: March 19, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Allergy

Allergies & Asthma

Allergy (Pediatric)

Treatment

Ligelizumab 240 mg

Ligelizumab 120 mg

Clinical Study ID

NCT05678959
CQGE031G12303B
2022-502366-25-00
2022-502366-25
  • Ages 6-57
  • All Genders

Study Summary

This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Signed informed consent form (ICF) and assent form (where applicable) obtained fromthe participant/legal representative before study participation. If a minorparticipant reaches the age of legal majority (as defined by local law), they mustbe re-consented at the next study visit

  • Participants have completed the treatment period in any ligelizumab Phase IIIstudies in food allergy

  • Participants who are willing to adhere to the study visits and procedures, includingreceiving injections (study treatment) and participating in the OL-OFC (open labeloral food challenge)

  • Participants who agree to continue avoiding exposure to allergens (per core study)and any other foods they are allergic to throughout this study

  • Participants who are able to safely continue into the study as judged by theinvestigator

Exclusion

Key Exclusion Criteria:

  • Development of a severe or life-threatening episode of an allergic reaction thatrequired intubation and/or ICU admission during the core studies

  • Development of a serious adverse event which is suspected to be related to the studytreatment judged by the investigator during the core study

  • Development of uncontrolled asthma during the core study that could compromise thesafety of the participants judged by the investigator

  • Development of clinically significant cardiovascular, neurological, and orpsychiatric conditions during the core study that could interfere with or compromisethe safety of the participants, interfere with evaluation or interpretation of thestudy results or preclude completion of the study judged by the investigator

  • Participants who failed to comply with the protocol requirements and proceduresduring the core study, and in the Investigator's opinion they should not participatein this extension study

  • Platelets <75,000/ul at end of treatment of the core study

Other protocol defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 163
Treatment Group(s): 2
Primary Treatment: Ligelizumab 240 mg
Phase: 3
Study Start date:
April 27, 2023
Estimated Completion Date:
March 06, 2025

Study Description

Participants will receive up to 3 years treatment with ligelizumab after which they will enter a follow-up period for 16 weeks. During the study, participants will undergo allergy testing by a Skin Prick Test and Oral Food challenge to test if the treatment is working or not. Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic patients in terms of safety, efficacy, pharmaco-dynamics, biomarkers and Qualify of Life, and potential discontinuation from treatment.

During the study, treatment will be administered every 4 weeks and while this can take place in the hospital clinic, some participants will be trained to administer study treatment at home by either the participant or parent/caregiver. Participants at home will record administration of the study treatment on a dosing log and return this to the clinic for review.

Connect with a study center

  • Novartis Investigative Site

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Ottawa, Ontario K1Y 4G2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M3B 3S6
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Quebec, G1V 4W2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Angers, 49033
    France

    Site Not Available

  • Novartis Investigative Site

    Angers Cedex 1, 49033
    France

    Site Not Available

  • Novartis Investigative Site

    Angers Cedex 9, 49933
    France

    Site Not Available

  • Novartis Investigative Site

    Lille, 59000
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse, 31400
    France

    Site Not Available

  • Novartis Investigative Site

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60596
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60596
    Germany

    Site Not Available

  • Novartis Investigative Site

    Padova, PD 35128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Sagamihara-city, Kanagawa 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 157-8535
    Japan

    Site Not Available

  • Novartis Investigative Site

    Utrecht, 3584
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Esplugues De Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08036
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Novartis Investigative Site

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Allergy and Immunology Associates

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Novartis Investigative Site

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Novartis Investigative Site

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Allergy and Asthma Associates of Santa Clara Vally Center

    San Jose, California 95117
    United States

    Site Not Available

  • Novartis Investigative Site

    San Jose, California 95117
    United States

    Active - Recruiting

  • Allergy and Asthma CR Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novartis Investigative Site

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UCHealth Outpatient Pavilion

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UCHealth Outpatient Pavilion .

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Novartis Investigative Site

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa, Florida 33613
    United States

    Site Not Available

  • Children's Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Childrens Healthcare of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Novartis Investigative Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Atlanta Allergy and Asthma Clinic

    Marietta, Georgia 30062
    United States

    Site Not Available

  • Atlanta Allergy and Asthma Clinic .

    Marietta, Georgia 30062
    United States

    Site Not Available

  • Novartis Investigative Site

    Marietta, Georgia 30062
    United States

    Site Not Available

  • Ann and Robert H Lurie Childrens Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Ann and Robert H Lurie Childrens Hospital of Chicago .

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Novartis Investigative Site

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University Indiana Uni School of Medicine

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Novartis Investigative Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Family Allergy and Asthma

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Novartis Investigative Site

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Johns Hopkins Childrens Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Childrens Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Ann Arbor, Michigan 48109-0922
    United States

    Active - Recruiting

  • University of Michigan Clinical Trials Office

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Clinical Trials Office Drug Shipment (3)

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Medical Ctr

    Ann Arbor, Michigan 48109-0922
    United States

    Site Not Available

  • Novartis Investigative Site

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Respiratory Medicine Research Institute of Michigan

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Novartis Investigative Site

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • UBMD Pediatrics

    Buffalo, New York 14203
    United States

    Site Not Available

  • Mt Sinai Medical Center

    New York, New York 10029-6574
    United States

    Site Not Available

  • Northwell Health

    New York, New York 10028
    United States

    Site Not Available

  • Northwell Health Main Center

    New York, New York 10028
    United States

    Site Not Available

  • Novartis Investigative Site

    New York, New York 10028
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Chapel Hill, North Carolina 27599-9500
    United States

    Active - Recruiting

  • University Of NC At Chapel Hill

    Chapel Hill, North Carolina 27599 9500
    United States

    Site Not Available

  • Cincinnati Childrens Hospital MC

    Cincinnati, Ohio 45229-3039
    United States

    Site Not Available

  • Cincinnati Childrens Hospital MC .

    Cincinnati, Ohio 45229-3039
    United States

    Site Not Available

  • Novartis Investigative Site

    Cincinnati, Ohio 45229-3039
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Childrens Hospital Of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Novartis Investigative Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Uni of TX SW Med Ctr

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • Novartis Investigative Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Childrens Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Novartis Investigative Site

    Seattle, Washington 98115
    United States

    Active - Recruiting

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington 98115
    United States

    Site Not Available

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