ong-term extension study of ligelizumab in food allergy
- Conditions
- Food allergyMedDRA version: 20.0Level: PTClassification code: 10016946Term: Food allergy Class: 100000004870MedDRA version: 20.0Level: LLTClassification code: 10077084Term: Allergic reaction to food Class: 10021428Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-502366-25-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
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 (e.g., Study CQGE031G12301). Please refer to the Section 4.1 for the timing of transition., 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
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 EoT of the core study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of ligelizumab in participants with food allergy;Secondary Objective: To describe the long-term efficacy of ligelizumab as measured by the tolerance of an allergen food protein during an open-label OFC at scheduled timepoints., To assess the safety and tolerability of ligelizumab in all participants who are administered study treatment at home by self-administration or parent/caregiver, To assess the long-term impact of ligelizumab on the health related quality of life (HRQoL) of patients with food allergy;Primary end point(s): Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of participants tolerating a single dose of = 600 mg of peanut protein without dose limiting symptoms during an open label OFC at scheduled timepoints;Secondary end point(s):Overall incidence and exposure-adjusted occurrence rates of treatment-emergent AEs and SAEs;Secondary end point(s):Summaries of total scores in the FAQLQ, FAIM and SF-36v2 by age and responder (participants and/or caregiver) at scheduled timepoints