Long-term Extension Study of Ligelizumab in Food Allergy

• Status: Not yet recruiting
• Trial end date: 2029-07-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Anti-Idiotypic

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 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

Other protocol defined inclusion/exclusion criteria may apply