Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT05678959
Eligibility Criteria:
Key Inclusion Criteria:
* Signed informed consent and or/assent (where applicable) obtained from participant/legal representative prior to enrolling in the rollover study and receiving study medication. If a minor participant providing assent reached the age of legal majority (as defined by local law), he/she was to be re-consented at the next study visit.
* Participants had completed the treatment period in any ligelizumab's Phase III studies in food allergy.
* Participants who were 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 agreed to continue avoiding exposure to allergens (per core study) and any other foods they were allergic to throughout this study.
* Participants who were able to safely continue into the study as judged by the investigator.
Key Exclusion Criteria:
* Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or intensive care unit (ICU) admission during the core studies.
* Development of a serious adverse event which was 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 compromised 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, should not participate in this extension study.
* Platelets \<75,000/ul at end of treatment of the core study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
57 Years
Study:
NCT05678959
Study Brief:
Protocol Section:
NCT05678959