Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

Peanut Allergy Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872218
• Other study ID #: CITO-2021-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Drug:
• Abatacept
24 week treatment of IV abatacept following recommended dosages from the monograph
• Placebo
24 week treatment of IV placebo following recommended dosages from the abatacept monograph

Other:
• Peanut oral immunotherapy
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Philippe Bégin

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atopy patch test	Change in peanut atopy patch test from baseline	week 12, week 24 and week 48
Other	Skin test	Change in peanut skin test from baseline	week 12, week 24 and week 48
Other	Peanut specific/total IgE, other time points	Relative change in peanut specific/total IgE from baseline	weeks 2, 6, 12, 36 and 48
Other	Peanut-specific IgG4/IgE ratio, other time points	Relative change in peanut-specific IgG4/IgE ratio from baseline	weeks 2, 6, 12, 36 and 48
Other	Peanut-specific IgG4, other time points	Absolute change from baseline in peanut-specific IgG4	weeks 2, 6, 12, 36 and 48
Primary	Peanut specific/total IgE at week 24	Relative change in peanut specific/total IgE from baseline to week 24	24 weeks
Secondary	Peanut-specific IgG4/IgE ratio at week 24	Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24	24 weeks
Secondary	Peanut-specific IgG4 at week 24	Absolute change in peanut-specific IgG4 from baseline to week 24	24 weeks
Secondary	Sustained tolerance	Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated	Assessed between week 36 and week 48
Secondary	Food dosing reactions	Mean cumulative function of food dosing allergic reactions	48 weeks
Secondary	Desensitization	Highest tolerated dose on an oral food challenge at week 36	36 weeks
Secondary	Desensitization speed	Time from the onset of oral immunotherapy to the maintenance dose of 300mg	36 weeks
Secondary	Adverse events	Overall rate of adverse events	48 weeks