Long-term Extension Study of Ligelizumab in Food Allergy (NCT05678959) | Clinical Trial Compass
TerminatedPhase 3
Long-term Extension Study of Ligelizumab in Food Allergy
Stopped: Sponsor decision
United States163 participantsStarted 2023-04-27
Plain-language summary
This was an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who completed a ligelizumab Phase III study in food allergy.
Who can participate
Age range6 Years – 57 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)