Study Description
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. 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.
Interventions
Ligelizumab 120 mg
Ligelizumab 240 mg
Eligibility 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
Study Location
Novartis Investigative Site
Recruiting
Toulouse,31400,France
Novartis Investigative Site
Recruiting
Lille,59000,France
Novartis Investigative Site
Recruiting
Angers,49033,France
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Dresden,01307,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60590,Germany
Novartis Investigative Site
Recruiting
Frankfurt,60596,Germany
Novartis Investigative Site
Recruiting
Padova,PD,35128,Italy
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Mt Sinai Medical Center
Recruiting
New York,New York,10029-6574,United States
Northwell Health Main Center
Recruiting
New York,New York,10028,United States
Worldwide Contacts
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