For Healthcare Professionals

Long-term Extension Study of Ligelizumab in Food Allergy

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Signed informed consent and assent form (where applicable)
  2. Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
  3. Participants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challenge
  4. Participants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the study
  5. Participants are able to safety continue into the study as judged by the investigator

EXCLUSION CRITERIA

Exclusion Criteria:

  1. 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
  2. Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studies
  3. Development of uncontrolled asthma during the core study that could compromise the safety of participants judged by the investigator
  4. 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
  5. 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
  6. Platelets <75,000/ul at end of treatment of the core study

Other protocol defined inclusion/exclusion criteria may apply

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study Details


Contition

Food Allergy

Age

6 - 57

Phase

PHASE3

Participants Needed

550

Est. Completion Date

Jul 6, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Novartis

ClinicalTrials.gov NCT Identifier

NCT05678959

Study Number

CQGE031G12303B

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