Long-term Extension Study of Ligelizumab in Food Allergy

Food Allergy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678959
• Other study ID #: CQGE031G12303B
• Secondary ID: 2022-502366-25
• Status: Recruiting
• Phase: Phase 3
• Start date: April 27, 2023
• Est. completion date: July 6, 2027

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: July 6, 2027
• Est. primary completion date: July 6, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 57 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Ligelizumab 120 mg
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo
• Ligelizumab 240 mg
2 injections of 1.0 mL ligelizumab

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Brisbane	Queensland
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	Parkville	Victoria
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Angers
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Vandoeuvre Les Nancy
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Frankfurt
Italy	Novartis Investigative Site	Padova	PD
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Setagaya-ku	Tokyo
Netherlands	Novartis Investigative Site	Utrecht
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Esplugues De Llobregat	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
United States	University of Michigan Medical Ctr	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	UCHealth Outpatient Pavilion .	Aurora	Colorado
United States	Johns Hopkins Childrens Center	Baltimore	Maryland
United States	Allervie Clinical Research	Birmingham	Alabama
United States	Boston Childrens Hospital	Boston	Massachusetts
United States	UBMD Pediatrics	Buffalo	New York
United States	University Of NC At Chapel Hill	Chapel Hill	North Carolina
United States	Ann and Robert H Lurie Childrens Hospital of Chicago .	Chicago	Illinois
United States	Cincinnati Childrens Hospital MC .	Cincinnati	Ohio
United States	Asthma and Allergy Associates P C	Colorado Springs	Colorado
United States	Uni of TX SW Med Ctr	Dallas	Texas
United States	Texas Childrens Hospital	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Family Allergy and Asthma	Louisville	Kentucky
United States	Atlanta Allergy and Asthma Clinic .	Marietta	Georgia
United States	Mt Sinai Medical Center	New York	New York
United States	Northwell Health Main Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Allergy and Asthma Associates of Santa Clara Vally Center	San Jose	California
United States	Allergy and Immunology Associates	Scottsdale	Arizona
United States	Seattle Allergy and Asthma Rsch	Seattle	Washington
United States	Univ of South Florida Asthma Allergy and Immunology CRU	Tampa	Florida
United States	Allergy and Asthma CR Inc	Walnut Creek	California
United States	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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