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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05678959




Registration number
NCT05678959
Ethics application status
Date submitted
9/01/2023
Date registered
10/01/2023

Titles & IDs
Public title
Long-term Extension Study of Ligelizumab in Food Allergy
Scientific 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
Secondary ID [1] 0 0
2022-502366-25-00
Secondary ID [2] 0 0
CQGE031G12303B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ligelizumab 120 mg
Treatment: Drugs - Ligelizumab 240 mg

Experimental: Ligelizumab 120 mg - 120 mg

Experimental: Ligelizumab 240 mg - 240 mg


Treatment: Drugs: Ligelizumab 120 mg
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo

Treatment: Drugs: Ligelizumab 240 mg
2 injections of 1.0 mL ligelizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of treatment-emergent AEs and SAEs
Timepoint [1] 0 0
Up to 172 weeks
Secondary outcome [1] 0 0
Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms
Timepoint [1] 0 0
Day 1, Week 52, Week 104, Week 156
Secondary outcome [2] 0 0
Number of treatment emergent AEs and SAEs
Timepoint [2] 0 0
Up to 172 weeks
Secondary outcome [3] 0 0
Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder
Timepoint [3] 0 0
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 outcome [4] 0 0
Scores in the Food Allergy Independent Measure (FAIM) by age and responder
Timepoint [4] 0 0
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 outcome [5] 0 0
Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder
Timepoint [5] 0 0
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

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
6 Years
Maximum age
57 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/07/2029
Actual
Sample size
Target
Accrual to date
Final
550
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Brisbane
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
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New York
Country [14] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Angers
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
France
State/province [24] 0 0
Vandoeuvre Les Nancy
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Frankfurt
Country [28] 0 0
Italy
State/province [28] 0 0
PD
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Netherlands
State/province [31] 0 0
Utrecht
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Catalunya
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05678959