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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04984876
Ethics application status
Date submitted
29/07/2021
Date registered
2/08/2021

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
Stopped early
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
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kentucky
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Maryland
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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Texas
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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
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France
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Toulouse
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Frankfurt
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Italy
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PD
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Japan
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Kanagawa
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Japan
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Tokyo
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Netherlands
State/province [33] 0 0
Utrecht
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Spain
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Barcelona
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Spain
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Catalunya
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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
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT04984876