Long-term Extension Study of Ligelizumab in Food Allergy

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants will receive up to 3 years treatment with ligelizumab after which they will enter a follow-up period for 16 weeks. During the study, participants will undergo allergy testing by a Skin Prick Test and Oral Food challenge to test if the treatment is working or not. Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic patients in terms of safety, efficacy, pharmaco-dynamics, biomarkers and Qualify of Life, and potential discontinuation from treatment. During the study, treatment will be administered every 4 weeks and while this can take place in the hospital clinic, some participants will be trained to administer study treatment at home by either the participant or parent/caregiver. Participants at home will record administration of the study treatment on a dosing log and return this to the clinic for review.

Official Title
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A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy

Conditions
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Food Allergy

Intervention / Treatment
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* Drug: Ligelizumab 120 mg
* Drug: Ligelizumab 240 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ligelizumab 120 mg<br>120 mg | Drug: Ligelizumab 120 mg<br>* 1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo<br>|
| Experimental: Ligelizumab 240 mg<br>240 mg | Drug: Ligelizumab 240 mg<br>* 2 injections of 1.0 mL ligelizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent AEs and SAEs | Long-term safety and tolerability of ligelizumab measured by incidence of Adverse Events and Serious Adverse Events An Adverse Event (AE) is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product. | Up to 172 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms | Long-term efficacy of ligelizumab | Day 1, Week 52, Week 104, Week 156 | 
| Number of treatment emergent AEs and SAEs | Safety and tolerability of ligelizumab in all participants who administered study treatment at home by self-administration or parent/caregiver | Up to 172 weeks | 
| Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder | Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Questions are scored on a 7 point scale from 1 (no) to 7 (maximal) impairment on quality of life. | Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 | 
| Scores in the Food Allergy Independent Measure (FAIM) by age and responder | Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Scores range from 1 (limited) to 7 (greatest) percieved food allergy severity and food allergy related risk. | Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 | 
| Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder | Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. This 36 item instrument measures the impact of food allergy on social activities and depressions/nervousness. | Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food allergy, oral food challenge, IgE, ligelizumab