Clinical trial NCT05678959: Long-term Extension Study of Ligelizumab in Food Allergy
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Food Allergy
Keywords: Food allergy
Peanut allergy
Oral food challenge (OFC)
Immunoglobulin E (IgE)
ligelizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 163
Sex: ALL
Minimum age (years): 6
Maximum age (years): 57
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.

Detailed description: 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.

Eligibility criteria: Key Inclusion Criteria:

* Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
* Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
* Participants who are 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 agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study
* Participants who are 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 ICU 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 study
* Development of uncontrolled asthma during the core study that could compromise the safety of the 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 during the 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

Primary outcomes:
measure: Number of treatment-emergent AEs and SAEs
timeFrame: Up to 172 weeks
Secondary outcomes:
measure: Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms
timeFrame: Day 1, Week 52, Week 104, Week 156
measure: Number of treatment emergent AEs and SAEs
timeFrame: Up to 172 weeks
measure: Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder
timeFrame: 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
measure: Scores in the Food Allergy Independent Measure (FAIM) by age and responder
timeFrame: 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
measure: Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Allervie Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Allergy and Immunology Associates
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Vally Center
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research Inc
state: California
city: Aurora
country: United States
facility: UCHealth Outpatient Pavilion
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates P C
state: Colorado
city: Tampa
country: United States
facility: Univ of South Florida Asthma Allergy and Immunology CRU
state: Florida
city: Atlanta
country: United States
facility: Childrens Healthcare of Atlanta
state: Georgia
city: Marietta
country: United States
facility: Atlanta Allergy and Asthma Clinic
state: Georgia
city: Chicago
country: United States
facility: Ann and Robert H Lurie Childrens Hospital of Chicago
state: Illinois
city: Louisville
country: United States
facility: Family Allergy and Asthma
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Childrens Center
state: Maryland
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Clinical Trials Office
state: Michigan
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: Buffalo
country: United States
facility: UBMD Pediatrics
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mt Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of NC At Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital MC
state: Ohio
city: Philadelphia
country: United States
facility: Childrens Hospital Of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Allergy and Asthma Rsch
state: Washington
city: Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Angers Cedex 9
country: France
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Vandoeuvre Les Nancy
country: France
facility: Novartis Investigative Site
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Esplugues De Llobregat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: