Long-term Extension Study of Ligelizumab in Food Allergy
- Conditions
- Food Allergy
- Interventions
- Registration Number
- NCT05678959
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 163
- Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
- Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
- Participants who are 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 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 the investigator
Key
- Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or ICU 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 study
- Development of uncontrolled asthma during the core study that could compromise the safety of the 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 during the 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ligelizumab 240 mg Ligelizumab 240 mg 240 mg Ligelizumab 120 mg Ligelizumab 120 mg 120 mg
- Primary Outcome Measures
Name Time Method Number of treatment-emergent AEs and SAEs Up to 172 weeks Long-term safety and tolerability of ligelizumab measured by incidence of Adverse Events and Serious Adverse Events
An Adverse Event (AE) is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
- Secondary Outcome Measures
Name Time Method Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms Day 1, Week 52, Week 104, Week 156 Long-term efficacy of ligelizumab
Scores in the Food Allergy Independent Measure (FAIM) by age and responder Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Scores range from 1 (limited) to 7 (greatest) perceived food allergy severity and food allergy related risk.
Number of treatment emergent AEs and SAEs Up to 172 weeks Safety and tolerability of ligelizumab in all participants who administered study treatment at home by self-administration or parent/caregiver
Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Questions are scored on a 7 point scale from 1 (no) to 7 (maximal) impairment on quality of life.
Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. This 36 item instrument measures the impact of food allergy on social activities and depressions/nervousness.
Trial Locations
- Locations (26)
UBMD Pediatrics
🇺🇸Buffalo, New York, United States
Ann and Robert H Lurie Childrens Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Family Allergy and Asthma
🇺🇸Louisville, Kentucky, United States
Johns Hopkins Childrens Center
🇺🇸Baltimore, Maryland, United States
Boston Childrens Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Clinical Trials Office
🇺🇸Ann Arbor, Michigan, United States
Respiratory Medicine Research Institute of Michigan
🇺🇸Ypsilanti, Michigan, United States
Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
Allergy and Immunology Associates
🇺🇸Scottsdale, Arizona, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Allergy and Asthma Associates of Santa Clara Vally Center
🇺🇸San Jose, California, United States
Allergy and Asthma Clinical Research Inc
🇺🇸Walnut Creek, California, United States
UCHealth Outpatient Pavilion
🇺🇸Aurora, Colorado, United States
Asthma and Allergy Associates P C
🇺🇸Colorado Springs, Colorado, United States
Univ of South Florida Asthma Allergy and Immunology CRU
🇺🇸Tampa, Florida, United States
Childrens Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Atlanta Allergy and Asthma Clinic
🇺🇸Marietta, Georgia, United States
Northwell Health
🇺🇸New York, New York, United States
Mt Sinai Medical Center
🇺🇸New York, New York, United States
University Of NC At Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cincinnati Childrens Hospital MC
🇺🇸Cincinnati, Ohio, United States
Childrens Hospital Of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Texas Childrens Hospital
🇺🇸Houston, Texas, United States
Seattle Allergy and Asthma Rsch
🇺🇸Seattle, Washington, United States
Novartis Investigative Site
🇪🇸Madrid, Spain