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NCT05678959
Long-term Extension Study of Ligelizumab in Food Allergy
Conditions: Food Allergy
Sex: All
Ages: 6 Years – 57 Years
Phase: PHASE3
Enrollment: 550
Sponsor: Novartis Pharmaceuticals
Summary
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.
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 allergyParticipants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challengeParticipants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the studyParticipants are able to safety continue into the study as judged by the investigatorExclusion 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 studiesDevelopment of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studiesDevelopment of uncontrolled asthma during the core study that could compromise the safety of participants judged by the investigatorDevelopment 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 investigatorParticipants 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 studyPlatelets <75,000/ul at end of treatment of the core studyOther protocol defined inclusion/exclusion criteria may apply
Source: ClinicalTrials.gov (NCT05678959). StuddyBuddy aggregates publicly available trial information.