Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy (ATARI)

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

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.

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Abatacept; Other: Peanut oral immunotherapy; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Peanut oral immunotherapy; Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.; Drug: Placebo; 24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Experimental: Abatacept	Drug: Abatacept; 24 week treatment of IV abatacept following recommended dosages from the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peanut specific/total IgE at week 24	Relative change in peanut specific/total IgE from baseline to week 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peanut-specific IgG4/IgE ratio at week 24	Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24	24 weeks
Peanut-specific IgG4 at week 24	Absolute change in peanut-specific IgG4 from baseline to week 24	24 weeks
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
Food dosing reactions	Mean cumulative function of food dosing allergic reactions	48 weeks
Desensitization	Highest tolerated dose on an oral food challenge at week 36	36 weeks
Desensitization speed	Time from the onset of oral immunotherapy to the maintenance dose of 300mg	36 weeks
Adverse events	Overall rate of adverse events	48 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atopy patch test	Change in peanut atopy patch test from baseline	week 12, week 24 and week 48
Skin test	Change in peanut skin test from baseline	week 12, week 24 and week 48
Peanut specific/total IgE, other time points	Relative change in peanut specific/total IgE from baseline	weeks 2, 6, 12, 36 and 48
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
Peanut-specific IgG4, other time points	Absolute change from baseline in peanut-specific IgG4	weeks 2, 6, 12, 36 and 48

Collaborators and Investigators

• Sponsor: Philippe Bégin

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Peanut allergy; Abatacept; Oral immunotherapy
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Food Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Abatacept
• Other Study ID Numbers: CITO-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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