FARE - Food Allergy Research & Education Logo

Long-term Extension Study of Ligelizumab in Food Allergy

Study Purpose

This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in particiants who have completed a ligelizumab Phase III study in food 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 - 57 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Signed informed consent and assent form (where applicable) - Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy.
  • - Participants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challenge.
  • - Participants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the study.
  • - Participants are able to safety continue into the study as judged by the investigator.

Exclusion Criteria:

  • - Development of a severe or life threatening episode of an allergic reaction that required intubation and/or Intensive Care Unit admission during the core studies.
  • - Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studies.
  • - Development of uncontrolled asthma during the core study that could compromise the safety of participants judged by the investigator.
  • - Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator.
  • - Participants who failed to comply with the protocol requirements and procedures duringthe core study, and in the Investigator's opinion they should not participate in this extension study.
  • - Platelets <75,000/ul at end of treatment of the core study.
Other protocol defined inclusion/exclusion criteria may apply

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.

NCT05678959
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, France, Germany, Italy, Japan, Netherlands, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Additional Details

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.

Arms & Interventions

Arms

Experimental: Ligelizumab 120 mg

120 mg

Experimental: Ligelizumab 240 mg

240 mg

Interventions

Drug: - Ligelizumab 120 mg

1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo

Drug: - Ligelizumab 240 mg

2 injections of 1.0 mL ligelizumab

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.

Allervie Clinical Research, Birmingham, Alabama

Status

Active, not recruiting

Address

Allervie Clinical Research

Birmingham, Alabama, 35209

Allergy and Immunology Associates, Scottsdale, Arizona

Status

Active, not recruiting

Address

Allergy and Immunology Associates

Scottsdale, Arizona, 85251

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Active, not recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

San Jose, California

Status

Active, not recruiting

Address

Allergy and Asthma Associates of Santa Clara Vally Center

San Jose, California, 95117

Allergy and Asthma CR Inc, Walnut Creek, California

Status

Active, not recruiting

Address

Allergy and Asthma CR Inc

Walnut Creek, California, 94598

UCHealth Outpatient Pavilion ., Aurora, Colorado

Status

Active, not recruiting

Address

UCHealth Outpatient Pavilion .

Aurora, Colorado, 80045

Asthma and Allergy Associates P C, Colorado Springs, Colorado

Status

Active, not recruiting

Address

Asthma and Allergy Associates P C

Colorado Springs, Colorado, 80907

Tampa, Florida

Status

Active, not recruiting

Address

Univ of South Florida Asthma Allergy and Immunology CRU

Tampa, Florida, 33613

Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Active, not recruiting

Address

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342

Atlanta Allergy and Asthma Clinic ., Marietta, Georgia

Status

Active, not recruiting

Address

Atlanta Allergy and Asthma Clinic .

Marietta, Georgia, 30062

Chicago, Illinois

Status

Active, not recruiting

Address

Ann and Robert H Lurie Childrens Hospital of Chicago .

Chicago, Illinois, 60611

Novartis Investigative Site, Indianapolis, Indiana

Status

Withdrawn

Address

Novartis Investigative Site

Indianapolis, Indiana, 46202

Family Allergy and Asthma, Louisville, Kentucky

Status

Active, not recruiting

Address

Family Allergy and Asthma

Louisville, Kentucky, 40217

Johns Hopkins Childrens Center, Baltimore, Maryland

Status

Active, not recruiting

Address

Johns Hopkins Childrens Center

Baltimore, Maryland, 21287

Boston Childrens Hospital, Boston, Massachusetts

Status

Active, not recruiting

Address

Boston Childrens Hospital

Boston, Massachusetts, 02215

University of Michigan Medical Ctr, Ann Arbor, Michigan

Status

Active, not recruiting

Address

University of Michigan Medical Ctr

Ann Arbor, Michigan, 48109-0922

Ypsilanti, Michigan

Status

Active, not recruiting

Address

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, 48197

UBMD Pediatrics, Buffalo, New York

Status

Active, not recruiting

Address

UBMD Pediatrics

Buffalo, New York, 14203

Northwell Health Main Center, New York, New York

Status

Recruiting

Address

Northwell Health Main Center

New York, New York, 10028

Site Contact

Aaqil Ali

[email protected]

516-622-5070

Mt Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mt Sinai Medical Center

New York, New York, 10029-6574

Site Contact

Tracy Lo

[email protected]

212-659-5596

University Of NC At Chapel Hill, Chapel Hill, North Carolina

Status

Active, not recruiting

Address

University Of NC At Chapel Hill

Chapel Hill, North Carolina, 27599-9500

Cincinnati Childrens Hospital MC ., Cincinnati, Ohio

Status

Active, not recruiting

Address

Cincinnati Childrens Hospital MC .

Cincinnati, Ohio, 45229-3039

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Uni of TX SW Med Ctr, Dallas, Texas

Status

Active, not recruiting

Address

Uni of TX SW Med Ctr

Dallas, Texas, 75235

Texas Childrens Hospital, Houston, Texas

Status

Active, not recruiting

Address

Texas Childrens Hospital

Houston, Texas, 77030

Seattle Allergy and Asthma Rsch, Seattle, Washington

Status

Completed

Address

Seattle Allergy and Asthma Rsch

Seattle, Washington, 98115

International Sites

Novartis Investigative Site, Brisbane, Queensland, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

Brisbane, Queensland, 4101

Novartis Investigative Site, Parkville, Victoria, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

Parkville, Victoria, 3052

Novartis Investigative Site, Nedlands, Western Australia, Australia

Status

Active, not recruiting

Address

Novartis Investigative Site

Nedlands, Western Australia, 6009

Novartis Investigative Site, Hamilton, Ontario, Canada

Status

Active, not recruiting

Address

Novartis Investigative Site

Hamilton, Ontario, L8N 3Z5

Novartis Investigative Site, Ottawa, Ontario, Canada

Status

Active, not recruiting

Address

Novartis Investigative Site

Ottawa, Ontario, K1Y 4G2

Novartis Investigative Site, Toronto, Ontario, Canada

Status

Active, not recruiting

Address

Novartis Investigative Site

Toronto, Ontario, M3B 3S6

Novartis Investigative Site, Montreal, Quebec, Canada

Status

Active, not recruiting

Address

Novartis Investigative Site

Montreal, Quebec, H3T 1C5

Novartis Investigative Site, Quebec, Canada

Status

Active, not recruiting

Address

Novartis Investigative Site

Quebec, , G1V 4W2

Novartis Investigative Site, Angers, France

Status

Recruiting

Address

Novartis Investigative Site

Angers, , 49033

Novartis Investigative Site, Lille, France

Status

Recruiting

Address

Novartis Investigative Site

Lille, , 59000

Novartis Investigative Site, Toulouse, France

Status

Recruiting

Address

Novartis Investigative Site

Toulouse, , 31400

Novartis Investigative Site, Vandoeuvre Les Nancy, France

Status

Active, not recruiting

Address

Novartis Investigative Site

Vandoeuvre Les Nancy, , 54511

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 13353

Novartis Investigative Site, Dresden, Germany

Status

Recruiting

Address

Novartis Investigative Site

Dresden, , 01307

Novartis Investigative Site, Frankfurt, Germany

Status

Recruiting

Address

Novartis Investigative Site

Frankfurt, , 60590

Novartis Investigative Site, Frankfurt, Germany

Status

Recruiting

Address

Novartis Investigative Site

Frankfurt, , 60596

Novartis Investigative Site, Padova, PD, Italy

Status

Recruiting

Address

Novartis Investigative Site

Padova, PD, 35128

Novartis Investigative Site, Sagamihara-city, Kanagawa, Japan

Status

Active, not recruiting

Address

Novartis Investigative Site

Sagamihara-city, Kanagawa, 252-0392

Novartis Investigative Site, Setagaya-ku, Tokyo, Japan

Status

Active, not recruiting

Address

Novartis Investigative Site

Setagaya-ku, Tokyo, 157-8535

Novartis Investigative Site, Utrecht, Netherlands

Status

Active, not recruiting

Address

Novartis Investigative Site

Utrecht, , 3584CX

Novartis Investigative Site, Esplugues De Llobregat, Barcelona, Spain

Status

Active, not recruiting

Address

Novartis Investigative Site

Esplugues De Llobregat, Barcelona, 08950

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, Catalunya, 08036

Novartis Investigative Site, Madrid, Spain

Status

Active, not recruiting

Address

Novartis Investigative Site

Madrid, , 28009

Novartis Investigative Site, Madrid, Spain

Status

Active, not recruiting

Address

Novartis Investigative Site

Madrid, , 28040

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.