Long-term Extension Study of Ligelizumab in Food Allergy

Last updated: October 21, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Terminated

Phase

3

Condition

Allergies & Asthma

Allergy (Peanut)

Allergy

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Signed informed consent and or/assent (where applicable) obtained fromparticipant/legal representative prior to enrolling in the rollover study andreceiving study medication. If a minor participant providing assent reached the ageof legal majority (as defined by local law), he/she was to be re-consented at thenext study visit.

  • Participants had completed the treatment period in any ligelizumab's Phase IIIstudies in food allergy.

  • Participants who were willing to adhere to the study visits and procedures,including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge).

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

  • Participants who were 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 intensive care unit (ICU) admission during the corestudies.

  • Development of a serious adverse event which was suspected to be related to thestudy treatment judged by the investigator during the core study.

  • Development of uncontrolled asthma during the core study that compromised the safetyof 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, should not participate inthis extension study.

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

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

This was a 3-year extension study with a 16-week follow-up period. The study enabled participants from planned multiple Phase III "core" studies to roll over to this extension study once the participants had completed predefined minimal requirements of a "core" study and agreed to consent to participate in this study.

Participants received ligelizumab treatment allocated in the core study, except for maximum responder (MR) participants performing conditional discontinuation of study treatment. Any participant considered a MR, as defined by an oral food challenge (OFC), performed conditional discontinuation of study treatment. This was to assess whether further treatment was still required because of disease modification by ligelizumab and/or a change in the underlying phenotype following the natural history of the disease (outgrowth of allergy) demonstrated by sustained unresponsiveness.

A subset of participants was offered administration of study treatment at home either by the participant him/herself (self-administration) or by parent/caregiver following training at three visits at the clinic.

Connect with a study center

  • Novartis Investigative Site

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Novartis Investigative Site

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parkville, Victoria 3052
    Australia

    Site Not Available

  • Novartis Investigative Site

    Parkville 2153770, Victoria 2145234 3052
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands 2064874, Western Australia 2058645 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

    Hamilton 5969782, Ontario 6093943 L8N 3Z5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Ottawa 6094817, Ontario 6093943 K1Y 4G2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto 6167865, Ontario 6093943 M3B 3S6
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal 6077243, Quebec 6115047 H3T 1C5
    Canada

    Site Not Available

  • Novartis Investigative Site

    Québec 6325494, Quebec 6115047 G1V 4W2
    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 3037656, 49933
    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

    Lille 2998324, 59000
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse, 31400
    France

    Site Not Available

  • Novartis Investigative Site

    Toulouse 2972315, 31400
    France

    Site Not Available

  • Novartis Investigative Site

    Vandoeuvre Les Nancy, 54511
    France

    Site Not Available

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy 2970797, 54511
    France

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main 2925533, Hesse 2905330 60596
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin 2950159, 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

    Padua 3171728, PD 35128
    Italy

    Site Not Available

  • Novartis Investigative Site

    Sagamihara-city, Kanagawa 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sagamihara 11611609, Kanagawa 1860291 252-0392
    Japan

    Site Not Available

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 1850144 157-8535
    Japan

    Site Not Available

  • Novartis Investigative Site

    Utrecht, 3584
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Utrecht 2745912, 3584 CX
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Esplugues, Barcelona 08950
    Spain

    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

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid 3117735, 28009
    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

  • Allervie Clinical Research

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Site Not Available

  • Allergy and Immunology Associates

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Novartis Investigative Site

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Allergy and Immunology Associates

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Novartis Investigative Site

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock 4119403, Arkansas 4099753 72202
    United States

    Site Not Available

  • 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

  • Allergy and Asthma Associates of Santa Clara Vally Center

    San Jose 5392171, California 5332921 95117
    United States

    Site Not Available

  • Allergy and Asthma Clin Res Inc

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • 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

  • UCHealth Outpatient Pavilion

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Asthma and Allergy Associates P C

    Colorado Springs 5417598, Colorado 5417618 80907
    United States

    Site Not Available

  • 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

  • Univ of South Florida Asthma Allergy and Immunology CRU

    Tampa 4174757, Florida 4155751 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

  • Childrens Healthcare of Atlanta

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Atlanta Allergy and Asthma Clinic

    Marietta 4207783, Georgia 4197000 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

  • Ann and Robert H Lurie Childs Hosp

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • 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

  • Family Allergy and Asthma

    Louisville 4299276, Kentucky 6254925 40217
    United States

    Site Not Available

  • Johns Hopkins Childrens Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins Childrens Center

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Boston Childrens Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Novartis Investigative Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Boston Childrens Hospital

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • 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

  • University of Michigan Clinical Trials Office

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan

    Ypsilanti 5015688, Michigan 5001836 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

  • UBMD Pediatrics

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

  • Mt Sinai Medical Center

    New York 5128581, New York 5128638 10029-6574
    United States

    Site Not Available

  • Northwell Health

    New York 5128581, New York 5128638 10028
    United States

    Site Not Available

  • 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

  • University Of NC At Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 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

  • Cincinnati Childrens Hospital MC

    Cincinnati 4508722, Ohio 5165418 45229-3039
    United States

    Site Not Available

  • 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

  • Childrens Hospital Of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • 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

  • Unv of TX Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Texas Childrens Hospital

    Houston 4699066, Texas 4736286 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

  • Seattle Allergy and Asthma Rsch

    Seattle 5809844, Washington 5815135 98115
    United States

    Site Not Available

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