Phase
Condition
Allergy
Allergies & Asthma
Allergy (Pediatric)
Treatment
Ligelizumab 240 mg
Ligelizumab 120 mg
Clinical Study ID
Ages 6-57 All Genders
Study Summary
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
Study Description
Connect with a study center
Novartis Investigative Site
Brisbane, Queensland 4101
AustraliaSite Not Available
Novartis Investigative Site
Parkville, Victoria 3052
AustraliaSite Not Available
Novartis Investigative Site
Nedlands, Western Australia 6009
AustraliaSite Not Available
Novartis Investigative Site
Hamilton, Ontario L8N 3Z5
CanadaSite Not Available
Novartis Investigative Site
Ottawa, Ontario K1Y 4G2
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M3B 3S6
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Quebec, G1V 4W2
CanadaSite Not Available
Novartis Investigative Site
Angers, 49033
FranceSite Not Available
Novartis Investigative Site
Angers Cedex 1, 49033
FranceSite Not Available
Novartis Investigative Site
Angers Cedex 9, 49933
FranceSite Not Available
Novartis Investigative Site
Lille, 59000
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31400
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Novartis Investigative Site
Frankfurt am Main, Hessen 60596
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Frankfurt, 60596
GermanySite Not Available
Novartis Investigative Site
Padova, PD 35128
ItalySite Not Available
Novartis Investigative Site
Sagamihara-city, Kanagawa 252-0392
JapanSite Not Available
Novartis Investigative Site
Setagaya-ku, Tokyo 157-8535
JapanSite Not Available
Novartis Investigative Site
Utrecht, 3584
NetherlandsSite Not Available
Novartis Investigative Site
Esplugues De Llobregat, Barcelona 08950
SpainSite Not Available
Novartis Investigative Site
Barcelona, Catalunya 08036
SpainSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainSite Not Available
Allervie Clinical Research
Birmingham, Alabama 35209
United StatesSite Not Available
Novartis Investigative Site
Birmingham, Alabama 35209
United StatesActive - Recruiting
Allergy and Immunology Associates
Scottsdale, Arizona 85251
United StatesSite Not Available
Novartis Investigative Site
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Novartis Investigative Site
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Allergy and Asthma Associates of Santa Clara Vally Center
San Jose, California 95117
United StatesSite Not Available
Novartis Investigative Site
San Jose, California 95117
United StatesActive - Recruiting
Allergy and Asthma CR Inc
Walnut Creek, California 94598
United StatesSite Not Available
Allergy and Asthma Clinical Research Inc
Walnut Creek, California 94598
United StatesSite Not Available
Novartis Investigative Site
Walnut Creek, California 94598
United StatesActive - Recruiting
Novartis Investigative Site
Aurora, Colorado 80045
United StatesActive - Recruiting
UCHealth Outpatient Pavilion
Aurora, Colorado 80045
United StatesSite Not Available
UCHealth Outpatient Pavilion .
Aurora, Colorado 80045
United StatesSite Not Available
Asthma and Allergy Associates P C
Colorado Springs, Colorado 80907
United StatesSite Not Available
Novartis Investigative Site
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Novartis Investigative Site
Tampa, Florida 33613
United StatesActive - Recruiting
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa, Florida 33613
United StatesSite Not Available
Children's Healthcare of Atlanta
Atlanta, Georgia 30342
United StatesSite Not Available
Childrens Healthcare of Atlanta
Atlanta, Georgia 30342
United StatesSite Not Available
Novartis Investigative Site
Atlanta, Georgia 30342
United StatesSite Not Available
Atlanta Allergy and Asthma Clinic
Marietta, Georgia 30062
United StatesSite Not Available
Atlanta Allergy and Asthma Clinic .
Marietta, Georgia 30062
United StatesSite Not Available
Novartis Investigative Site
Marietta, Georgia 30062
United StatesSite Not Available
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Ann and Robert H Lurie Childrens Hospital of Chicago .
Chicago, Illinois 60611
United StatesSite Not Available
Novartis Investigative Site
Chicago, Illinois 60611
United StatesActive - Recruiting
Indiana University Indiana Uni School of Medicine
Indianapolis, Indiana 46202
United StatesSite Not Available
Novartis Investigative Site
Indianapolis, Indiana 46202
United StatesSite Not Available
Family Allergy and Asthma
Louisville, Kentucky 40217
United StatesSite Not Available
Novartis Investigative Site
Louisville, Kentucky 40217
United StatesActive - Recruiting
Johns Hopkins Childrens Center
Baltimore, Maryland 21287
United StatesSite Not Available
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
Boston Childrens Hospital
Boston, Massachusetts 02215
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
Novartis Investigative Site
Ann Arbor, Michigan 48109-0922
United StatesActive - Recruiting
University of Michigan Clinical Trials Office
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Clinical Trials Office Drug Shipment (3)
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Medical Ctr
Ann Arbor, Michigan 48109-0922
United StatesSite Not Available
Novartis Investigative Site
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan 48197
United StatesSite Not Available
Novartis Investigative Site
Buffalo, New York 14203
United StatesActive - Recruiting
UBMD Pediatrics
Buffalo, New York 14203
United StatesSite Not Available
Mt Sinai Medical Center
New York, New York 10029-6574
United StatesSite Not Available
Northwell Health
New York, New York 10028
United StatesSite Not Available
Northwell Health Main Center
New York, New York 10028
United StatesSite Not Available
Novartis Investigative Site
New York, New York 10028
United StatesActive - Recruiting
Novartis Investigative Site
Chapel Hill, North Carolina 27599-9500
United StatesActive - Recruiting
University Of NC At Chapel Hill
Chapel Hill, North Carolina 27599 9500
United StatesSite Not Available
Cincinnati Childrens Hospital MC
Cincinnati, Ohio 45229-3039
United StatesSite Not Available
Cincinnati Childrens Hospital MC .
Cincinnati, Ohio 45229-3039
United StatesSite Not Available
Novartis Investigative Site
Cincinnati, Ohio 45229-3039
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Novartis Investigative Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Novartis Investigative Site
Dallas, Texas 75235
United StatesActive - Recruiting
Uni of TX SW Med Ctr
Dallas, Texas 75235
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75235
United StatesSite Not Available
Novartis Investigative Site
Houston, Texas 77030
United StatesActive - Recruiting
Texas Childrens Hospital
Houston, Texas 77030
United StatesSite Not Available
Novartis Investigative Site
Seattle, Washington 98115
United StatesActive - Recruiting
Seattle Allergy and Asthma Rsch
Seattle, Washington 98115
United StatesSite Not Available
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