Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy (ATARI)
Primary Purpose
Peanut Allergy
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Abatacept
Placebo
Peanut oral immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Abatacept, Oral immunotherapy
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 14 to 50 years old at screening visit
- History of IgE mediated allergy to peanut protein
- ImmunoCAP IgE level > 50 kU/L for peanut;
- Total IgE level < 5000 kU/L
- Willing to comply to all study requirements during participation in the study;
Exclusion Criteria:
- Previous adverse reactions to abatacept;
- Known hypersensitivity to abatacept or any of its components;
- Patients at risk of sepsis, such as immunocompromised or HIV positive;
- Patient undergoing a treatment with any other biologic agent;
- Uncontrolled asthma;
- Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
- Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
- Concurrent/prior use of immunomodulatory therapy (within 6 months);
- A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
- Pregnant or breastfeeding women;
Sites / Locations
- CHU Sainte-JustineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Abatacept
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Peanut specific/total IgE at week 24
Relative change in peanut specific/total IgE from baseline to week 24
Secondary Outcome Measures
Peanut-specific IgG4/IgE ratio at week 24
Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Peanut-specific IgG4 at week 24
Absolute change in peanut-specific IgG4 from baseline to week 24
Sustained tolerance
Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Food dosing reactions
Mean cumulative function of food dosing allergic reactions
Desensitization
Highest tolerated dose on an oral food challenge at week 36
Desensitization speed
Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Adverse events
Overall rate of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04872218
Brief Title
Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
Acronym
ATARI
Official Title
A Double-blind Randomized Controlled Trial of 6-month of Abatacept vs Placebo as Adjuvant to Peanut Oral Immunotherapy to Induce Immunologic Changes in Patients With Severe Persistent Peanut Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philippe Bégin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adolescents and adults with persistent severe peanut allergy.
This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission.
Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut allergy, Abatacept, Oral immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abatacept
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
24 week treatment of IV abatacept following recommended dosages from the monograph
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Intervention Type
Other
Intervention Name(s)
Peanut oral immunotherapy
Intervention Description
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
Primary Outcome Measure Information:
Title
Peanut specific/total IgE at week 24
Description
Relative change in peanut specific/total IgE from baseline to week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Peanut-specific IgG4/IgE ratio at week 24
Description
Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Time Frame
24 weeks
Title
Peanut-specific IgG4 at week 24
Description
Absolute change in peanut-specific IgG4 from baseline to week 24
Time Frame
24 weeks
Title
Sustained tolerance
Description
Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Time Frame
Assessed between week 36 and week 48
Title
Food dosing reactions
Description
Mean cumulative function of food dosing allergic reactions
Time Frame
48 weeks
Title
Desensitization
Description
Highest tolerated dose on an oral food challenge at week 36
Time Frame
36 weeks
Title
Desensitization speed
Description
Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Time Frame
36 weeks
Title
Adverse events
Description
Overall rate of adverse events
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Atopy patch test
Description
Change in peanut atopy patch test from baseline
Time Frame
week 12, week 24 and week 48
Title
Skin test
Description
Change in peanut skin test from baseline
Time Frame
week 12, week 24 and week 48
Title
Peanut specific/total IgE, other time points
Description
Relative change in peanut specific/total IgE from baseline
Time Frame
weeks 2, 6, 12, 36 and 48
Title
Peanut-specific IgG4/IgE ratio, other time points
Description
Relative change in peanut-specific IgG4/IgE ratio from baseline
Time Frame
weeks 2, 6, 12, 36 and 48
Title
Peanut-specific IgG4, other time points
Description
Absolute change from baseline in peanut-specific IgG4
Time Frame
weeks 2, 6, 12, 36 and 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 14 to 50 years old at screening visit
History of IgE mediated allergy to peanut protein
ImmunoCAP IgE level > 50 kU/L for peanut;
Total IgE level < 5000 kU/L
Willing to comply to all study requirements during participation in the study;
Exclusion Criteria:
Previous adverse reactions to abatacept;
Known hypersensitivity to abatacept or any of its components;
Patients at risk of sepsis, such as immunocompromised or HIV positive;
Patient undergoing a treatment with any other biologic agent;
Uncontrolled asthma;
Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
Concurrent/prior use of immunomodulatory therapy (within 6 months);
A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
Pregnant or breastfeeding women;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maitena Montuzet, RN
Phone
514-345-4931
Ext
117375
Email
maitena.montuzet.hsj@ssss.gouv.qc.ca
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maitena Montuzet, RN
Phone
514-345-4931
Ext
117375
Email
maitena.montuzet.hsj@ssss.gouv.qc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
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