Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05678959
Registration number
NCT05678959
Ethics application status
Date submitted
9/01/2023
Date registered
10/01/2023
Date last updated
22/05/2024
Titles & IDs
Public title
Long-term Extension Study of Ligelizumab in Food Allergy
Query!
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
Query!
Secondary ID [1]
0
0
2022-502366-25
Query!
Secondary ID [2]
0
0
CQGE031G12303B
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Food Allergy
0
0
Query!
Condition category
Condition code
Inflammatory and Immune System
0
0
0
0
Query!
Allergies
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of treatment-emergent AEs and SAEs
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to 172 weeks
Query!
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
Query!
Assessment method [1]
0
0
Long-term efficacy of ligelizumab
Query!
Timepoint [1]
0
0
Day 1, Week 52, Week 104, Week 156
Query!
Secondary outcome [2]
0
0
Number of treatment emergent AEs and SAEs
Query!
Assessment method [2]
0
0
Safety and tolerability of ligelizumab in all participants who administered study treatment at home by self-administration or parent/caregiver
Query!
Timepoint [2]
0
0
Up to 172 weeks
Query!
Secondary outcome [3]
0
0
Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder
Query!
Assessment method [3]
0
0
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.
Query!
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
Query!
Secondary outcome [4]
0
0
Scores in the Food Allergy Independent Measure (FAIM) by age and responder
Query!
Assessment method [4]
0
0
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.
Query!
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
Query!
Secondary outcome [5]
0
0
Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder
Query!
Assessment method [5]
0
0
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.
Query!
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
Query!
Eligibility
Key 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
Query!
Minimum age
6
Years
Query!
Query!
Maximum age
57
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/04/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
6/07/2027
Query!
Actual
Query!
Sample size
Target
550
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Brisbane
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Parkville
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maryland
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New York
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
North Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Ontario
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Quebec
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Angers
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Lille
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Toulouse
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Vandoeuvre Les Nancy
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Berlin
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Dresden
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Frankfurt
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
PD
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Kanagawa
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Tokyo
Query!
Country [32]
0
0
Netherlands
Query!
State/province [32]
0
0
Utrecht
Query!
Country [33]
0
0
Spain
Query!
State/province [33]
0
0
Barcelona
Query!
Country [34]
0
0
Spain
Query!
State/province [34]
0
0
Catalunya
Query!
Country [35]
0
0
Spain
Query!
State/province [35]
0
0
Madrid
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05678959
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-888-669-6682
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05678959
Download to PDF