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Completed

NCT Number: NCT04872218

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

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.

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Key information

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Abatacept

Drug

24 week treatment of IV abatacept following recommended dosages from the monograph

Placebo

Drug

24 week treatment of IV placebo following recommended dosages from the abatacept monograph

Peanut oral immunotherapy

Other

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

Primary outcomes

  1. Peanut specific/total IgE at week 24

    Time frame: 24 weeks

    Relative change in peanut specific/total IgE from baseline to week 24

Secondary outcomes

  1. Peanut-specific IgG4/IgE ratio at week 24

    Time frame: 24 weeks

    Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24

  2. Peanut-specific IgG4 at week 24

    Time frame: 24 weeks

    Absolute change in peanut-specific IgG4 from baseline to week 24

  3. Sustained tolerance

    Time frame: Assessed between week 36 and week 48

    Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated

  4. Food dosing reactions

    Time frame: 48 weeks

    Mean cumulative function of food dosing allergic reactions

  5. Desensitization

    Time frame: 36 weeks

    Highest tolerated dose on an oral food challenge at week 36

  6. Desensitization speed

    Time frame: 36 weeks

    Time from the onset of oral immunotherapy to the maintenance dose of 300mg

  7. Adverse events

    Time frame: 48 weeks

    Overall rate of adverse events

Other outcomes

  1. Atopy patch test

    Time frame: week 12, week 24 and week 48

    Change in peanut atopy patch test from baseline

  2. Skin test

    Time frame: week 12, week 24 and week 48

    Change in peanut skin test from baseline

  3. Peanut specific/total IgE, other time points

    Time frame: weeks 2, 6, 12, 36 and 48

    Relative change in peanut specific/total IgE from baseline

  4. Peanut-specific IgG4/IgE ratio, other time points

    Time frame: weeks 2, 6, 12, 36 and 48

    Relative change in peanut-specific IgG4/IgE ratio from baseline

  5. Peanut-specific IgG4, other time points

    Time frame: weeks 2, 6, 12, 36 and 48

    Absolute change from baseline in peanut-specific IgG4

Sponsors and collaborators

Lead sponsor

Philippe Bégin

Other

Registry information

Official study 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

Acronym: ATARI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 4, 2021
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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