A three-year, multi-center, double-blind, extension study to evaluate the long-term safety and efficacy of ligelizumab in patients who completed ligelizumab's Phase III studies in food allergy.
K
Kirsten Kloepfer, MD
Primary Investigator
Overview
What is this study about?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - the research team will directly contact participants who have completed the treatment period in any ligelizumab Phase III studies in food allergy.
Description
What is involved in this study?
- 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.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
food allergy
-
Age: Between 6 Years - 57 Years
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Gender: All
Inclusion Criteria:
- 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
Updated on
02 May 2024.
Study ID: PPUL-NOVARTIS-QGE031-EXT, 19806
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