Phase
Condition
Allergies & Asthma
Allergy (Peanut)
Allergy
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 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
Study Description
Connect with a study center
Novartis Investigative Site
Brisbane, Queensland 4101
AustraliaSite Not Available
Novartis Investigative Site
Brisbane 2174003, Queensland 2152274 4101
AustraliaSite Not Available
Novartis Investigative Site
Parkville, Victoria 3052
AustraliaSite Not Available
Novartis Investigative Site
Parkville 2153770, Victoria 2145234 3052
AustraliaSite Not Available
Novartis Investigative Site
Nedlands, Western Australia 6009
AustraliaSite Not Available
Novartis Investigative Site
Nedlands 2064874, Western Australia 2058645 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
Hamilton 5969782, Ontario 6093943 L8N 3Z5
CanadaSite Not Available
Novartis Investigative Site
Ottawa 6094817, Ontario 6093943 K1Y 4G2
CanadaSite Not Available
Novartis Investigative Site
Toronto 6167865, Ontario 6093943 M3B 3S6
CanadaSite Not Available
Novartis Investigative Site
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Montreal 6077243, Quebec 6115047 H3T 1C5
CanadaSite Not Available
Novartis Investigative Site
Québec 6325494, Quebec 6115047 G1V 4W2
CanadaSite Not Available
Novartis Investigative Site
Quebec, G1V 4W2
CanadaSite Not Available
Novartis Investigative Site
Angers, 49033
FranceSite Not Available
Novartis Investigative Site
Angers 3037656, 49933
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
Lille 2998324, 59000
FranceSite Not Available
Novartis Investigative Site
Toulouse, 31400
FranceSite Not Available
Novartis Investigative Site
Toulouse 2972315, 31400
FranceSite Not Available
Novartis Investigative Site
Vandoeuvre Les Nancy, 54511
FranceSite Not Available
Novartis Investigative Site
Vandœuvre-lès-Nancy 2970797, 54511
FranceSite Not Available
Novartis Investigative Site
Frankfurt am Main 2925533, Hesse 2905330 60596
GermanySite Not Available
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Novartis Investigative Site
Dresden 2935022, Saxony 2842566 01307
GermanySite Not Available
Novartis Investigative Site
Berlin, 13353
GermanySite Not Available
Novartis Investigative Site
Berlin 2950159, 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
Padua 3171728, PD 35128
ItalySite Not Available
Novartis Investigative Site
Sagamihara-city, Kanagawa 252-0392
JapanSite Not Available
Novartis Investigative Site
Sagamihara 11611609, Kanagawa 1860291 252-0392
JapanSite Not Available
Novartis Investigative Site
Setagaya-ku, Tokyo 1850144 157-8535
JapanSite Not Available
Novartis Investigative Site
Utrecht, 3584
NetherlandsSite Not Available
Novartis Investigative Site
Utrecht 2745912, 3584 CX
NetherlandsSite Not Available
Novartis Investigative Site
Esplugues, Barcelona 08950
SpainSite 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
Barcelona 3128760, 08036
SpainSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainSite Not Available
Novartis Investigative Site
Madrid 3117735, 28009
SpainSite Not Available
Allervie Clinical Research
Birmingham, Alabama 35209
United StatesSite Not Available
Novartis Investigative Site
Birmingham, Alabama 35209
United StatesActive - Recruiting
Allervie Clinical Research
Birmingham 4049979, Alabama 4829764 35209
United StatesSite Not Available
Allergy and Immunology Associates
Scottsdale, Arizona 85251
United StatesSite Not Available
Novartis Investigative Site
Scottsdale, Arizona 85251
United StatesActive - Recruiting
Allergy and Immunology Associates
Scottsdale 5313457, Arizona 5551752 85251
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Novartis Investigative Site
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753 72202
United StatesSite Not Available
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
Allergy and Asthma Associates of Santa Clara Vally Center
San Jose 5392171, California 5332921 95117
United StatesSite Not Available
Allergy and Asthma Clin Res Inc
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
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
UCHealth Outpatient Pavilion
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Asthma and Allergy Associates P C
Colorado Springs 5417598, Colorado 5417618 80907
United StatesSite Not Available
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
Univ of South Florida Asthma Allergy and Immunology CRU
Tampa 4174757, Florida 4155751 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
Childrens Healthcare of Atlanta
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Atlanta Allergy and Asthma Clinic
Marietta 4207783, Georgia 4197000 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
Ann and Robert H Lurie Childs Hosp
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
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
Family Allergy and Asthma
Louisville 4299276, Kentucky 6254925 40217
United StatesSite Not Available
Johns Hopkins Childrens Center
Baltimore, Maryland 21287
United StatesSite Not Available
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
Johns Hopkins Childrens Center
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Boston Childrens Hospital
Boston, Massachusetts 02215
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02215
United StatesActive - Recruiting
Boston Childrens Hospital
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
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
University of Michigan Clinical Trials Office
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Respiratory Medicine Research Institute of Michigan
Ypsilanti 5015688, Michigan 5001836 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
UBMD Pediatrics
Buffalo 5110629, New York 5128638 14203
United StatesSite Not Available
Mt Sinai Medical Center
New York 5128581, New York 5128638 10029-6574
United StatesSite Not Available
Northwell Health
New York 5128581, New York 5128638 10028
United StatesSite Not Available
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
University Of NC At Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 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
Cincinnati Childrens Hospital MC
Cincinnati 4508722, Ohio 5165418 45229-3039
United StatesSite Not Available
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
Childrens Hospital Of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
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
Unv of TX Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Texas Childrens Hospital
Houston 4699066, Texas 4736286 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
Seattle Allergy and Asthma Rsch
Seattle 5809844, Washington 5815135 98115
United StatesSite Not Available

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