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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.

Novartis Investigative Site, Birmingham, Alabama

Status

Recruiting

Address

Novartis Investigative Site

Birmingham, Alabama, 35209

Novartis Investigative Site, Scottsdale, Arizona

Status

Recruiting

Address

Novartis Investigative Site

Scottsdale, Arizona, 85251

Novartis Investigative Site, Little Rock, Arkansas

Status

Recruiting

Address

Novartis Investigative Site

Little Rock, Arkansas, 72202

Novartis Investigative Site, San Jose, California

Status

Recruiting

Address

Novartis Investigative Site

San Jose, California, 95117

Novartis Investigative Site, Walnut Creek, California

Status

Recruiting

Address

Novartis Investigative Site

Walnut Creek, California, 94598

Novartis Investigative Site, Aurora, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Aurora, Colorado, 80045

Novartis Investigative Site, Colorado Springs, Colorado

Status

Recruiting

Address

Novartis Investigative Site

Colorado Springs, Colorado, 80907

Novartis Investigative Site, Tampa, Florida

Status

Recruiting

Address

Novartis Investigative Site

Tampa, Florida, 33613

Novartis Investigative Site, Atlanta, Georgia

Status

Active, not recruiting

Address

Novartis Investigative Site

Atlanta, Georgia, 30342

Novartis Investigative Site, Marietta, Georgia

Status

Active, not recruiting

Address

Novartis Investigative Site

Marietta, Georgia, 30062

Novartis Investigative Site, Chicago, Illinois

Status

Recruiting

Address

Novartis Investigative Site

Chicago, Illinois, 60611

Novartis Investigative Site, Indianapolis, Indiana

Status

Recruiting

Address

Novartis Investigative Site

Indianapolis, Indiana, 46202

Novartis Investigative Site, Louisville, Kentucky

Status

Recruiting

Address

Novartis Investigative Site

Louisville, Kentucky, 40217

Novartis Investigative Site, Baltimore, Maryland

Status

Recruiting

Address

Novartis Investigative Site

Baltimore, Maryland, 21287

Novartis Investigative Site, Boston, Massachusetts

Status

Recruiting

Address

Novartis Investigative Site

Boston, Massachusetts, 02215

Novartis Investigative Site, Ann Arbor, Michigan

Status

Recruiting

Address

Novartis Investigative Site

Ann Arbor, Michigan, 48109-0922

Novartis Investigative Site, Ypsilanti, Michigan

Status

Recruiting

Address

Novartis Investigative Site

Ypsilanti, Michigan, 48197

Novartis Investigative Site, Buffalo, New York

Status

Recruiting

Address

Novartis Investigative Site

Buffalo, New York, 14203

Novartis Investigative Site, New York, New York

Status

Recruiting

Address

Novartis Investigative Site

New York, New York, 10028

Novartis Investigative Site, New York, New York

Status

Recruiting

Address

Novartis Investigative Site

New York, New York, 10029-6574

Novartis Investigative Site, Chapel Hill, North Carolina

Status

Recruiting

Address

Novartis Investigative Site

Chapel Hill, North Carolina, 27599-9500

Novartis Investigative Site, Cincinnati, Ohio

Status

Recruiting

Address

Novartis Investigative Site

Cincinnati, Ohio, 45229-3039

Novartis Investigative Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Novartis Investigative Site

Philadelphia, Pennsylvania, 19104

Novartis Investigative Site, Dallas, Texas

Status

Recruiting

Address

Novartis Investigative Site

Dallas, Texas, 75235

Novartis Investigative Site, Houston, Texas

Status

Recruiting

Address

Novartis Investigative Site

Houston, Texas, 77030

Novartis Investigative Site, Seattle, Washington

Status

Recruiting

Address

Novartis Investigative Site

Seattle, Washington, 98115

International Sites

Novartis Investigative Site, Brisbane, Queensland, Australia

Status

Recruiting

Address

Novartis Investigative Site

Brisbane, Queensland, 4101

Novartis Investigative Site, Parkville, Victoria, Australia

Status

Recruiting

Address

Novartis Investigative Site

Parkville, Victoria, 3052

Novartis Investigative Site, Nedlands, Western Australia, Australia

Status

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

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 Cedex 1, France

Status

Recruiting

Address

Novartis Investigative Site

Angers Cedex 1, , 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

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

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

Recruiting

Address

Novartis Investigative Site

Utrecht, , 3584CX

Novartis Investigative Site, Esplugues De Llobregat, Barcelona, Spain

Status

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

Recruiting

Address

Novartis Investigative Site

Madrid, , 28009

Novartis Investigative Site, Madrid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Madrid, , 28040

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