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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04984876




Registration number
NCT04984876
Ethics application status
Date submitted
29/07/2021
Date registered
2/08/2021
Date last updated
19/03/2024

Titles & IDs
Public title
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
Scientific title
A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy
Secondary ID [1] 0 0
2020-005339-56
Secondary ID [2] 0 0
CQGE031G12301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy, Peanut 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
Treatment: Drugs - Placebo

Experimental: ligelizumab 240 mg - ligelizumab 240 mg subcutaneous injection for 52 weeks

Experimental: ligelizumab 120 mg - ligelizumab 120 mg subcutaneous injection for 52 weeks

Experimental: Placebo 8 weeks and ligelizumab 120 mg - Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

Experimental: Placebo 16 weeks and ligelizumab 120 mg/240 mg - Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

Experimental: Placebo 8 weeks and ligelizumab 240 mg - Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks


Treatment: Drugs: ligelizumab
Subcutaneous injection once every 4 weeks

Treatment: Drugs: Placebo
Subcutaneous injection once every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants who can tolerate a single dose of = 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants who can tolerate a single dose of = 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants who can tolerate a single dose of 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000 mg at Week 12
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants who can tolerate a single dose of = 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 52
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Change in maximum tolerated dose (MTD) of peanut protein without dose-limiting symptoms during the DBPCFC at Week 52 compared to Week 12
Timepoint [5] 0 0
Week 12 and Week 52
Secondary outcome [6] 0 0
Change from baseline in peanut-specific IgE at Week 12, Week 16 and Week 52
Timepoint [6] 0 0
Baseline, Week 12, 16 and 52
Secondary outcome [7] 0 0
Change from baseline in peanut-specific IgG4 at Week 12, Week 16 and 52
Timepoint [7] 0 0
Baseline, Week 12, 16 and 52
Secondary outcome [8] 0 0
Change from baseline in SPT mean wheal diameters at Week 16, Week 56 and Week 68
Timepoint [8] 0 0
Baseline, Week 16, 56 and 68
Secondary outcome [9] 0 0
Change from baseline in total and domain scores in the FAQLQ by age and responder (subject and/or caregiver)
Timepoint [9] 0 0
Baseline, Week 12 and 56
Secondary outcome [10] 0 0
Change from baseline in total and domain scores in the FAIM by age and responder (subject and/or caregiver)
Timepoint [10] 0 0
Baseline, Week 12 and 56
Secondary outcome [11] 0 0
Change from baseline in total and domain scores in the SF-36v2 by age and responder (subject and/or caregiver)
Timepoint [11] 0 0
Baseline, Week 12 and 56

Eligibility
Key inclusion criteria
- Male or female participants who are = 6 and = 55 years of age at the time of signing
informed consent/assent.

- Documented medical history of allergy to peanuts or peanut-containing foods.

- Positive peanut-specific immunoglobulin E (peanut sIgE), = 0.35 kUA/L at Screening
visit 1 (Screening 1).

- Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an
average diameter (Longest diameter and mid-point orthogonal diameter) = 4 mm wheal
compared to saline control.

- A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC)
defined as the occurrence of dose-limiting symptoms at a single dose = 100 mg of
peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all
other eligibility criteria.

- Participants must weigh = 20 kg at Screening 1.
Minimum age
6 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Total IgE >2000 IU/mL at Screening 1.

- History of severe or life-threatening hypersensitivity event needing an ICU admission
or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).

- Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who
meet any of the following criteria:

- FEV1 <80% of subject's predicted normal value at Screening visit 1

- One hospitalization for asthma within 12 months prior to Screening visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/11/2023
Sample size
Target
Accrual to date
Final
211
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
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Denmark
State/province [22] 0 0
Odense
Country [23] 0 0
France
State/province [23] 0 0
Angers Cedex 1
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Toulouse
Country [26] 0 0
France
State/province [26] 0 0
Vandoeuvre Les Nancy
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Dresden
Country [29] 0 0
Germany
State/province [29] 0 0
Frankfurt
Country [30] 0 0
Italy
State/province [30] 0 0
PD
Country [31] 0 0
Japan
State/province [31] 0 0
Kanagawa
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Netherlands
State/province [33] 0 0
Utrecht
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Catalunya
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled
study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240
mg and 120 mg) subcutaneous injection every 4 weeks (SCq4w) in participants with a medically
confirmed diagnosis of IgE-mediated peanut allergy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04984876
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04984876