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CompletedNCT04872218ATARIUpdated Nov 27, 2024

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

A Phase 2 interventional study of Abatacept and Placebo in Peanut Allergy, sponsored by Philippe Bégin. Completed at 1 site in Canada. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Philippe Bégin · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
14 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Peanut Allergy

Keywords

  • Peanut allergy
  • Abatacept
  • Oral immunotherapy
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 14 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Philippe Bégin is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Abatacept

    Drug: Abatacept · Other: Peanut oral immunotherapy

  • Placebo comparator
    Placebo

    Drug: Placebo · Other: Peanut oral immunotherapy

Interventions

  • DrugAbatacept

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

  • DrugPlacebo

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

  • OtherPeanut oral immunotherapy

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

06

What researchers measure

Primary outcomes

  1. Peanut specific/total IgE at week 24

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

    Time frame: 24 weeks

Secondary outcomes

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

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

    Time frame: 24 weeks

  2. Peanut-specific IgG4 at week 24

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

    Time frame: 24 weeks

  3. Sustained tolerance

    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

  4. Food dosing reactions

    Mean cumulative function of food dosing allergic reactions

    Time frame: 48 weeks

  5. Desensitization

    Highest tolerated dose on an oral food challenge at week 36

    Time frame: 36 weeks

  6. Desensitization speed

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

    Time frame: 36 weeks

  7. Adverse events

    Overall rate of adverse events

    Time frame: 48 weeks

Other outcomes

  1. Atopy patch test

    Change in peanut atopy patch test from baseline

    Time frame: week 12, week 24 and week 48

  2. Skin test

    Change in peanut skin test from baseline

    Time frame: week 12, week 24 and week 48

  3. Peanut specific/total IgE, other time points

    Relative change in peanut specific/total IgE from baseline

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

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

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

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

  5. Peanut-specific IgG4, other time points

    Absolute change from baseline in peanut-specific IgG4

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

07

Study locations

1 site
  • CHU Sainte-Justine
    Montréal, Quebec H3T1C5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04872218
Lead sponsor
Philippe Bégin
Responsible party
Philippe Bégin (Associate professor, St. Justine's Hospital) — Sponsor-investigator
First posted
May 4, 2021
Start date
Mar 1, 2022
Primary completion
May 10, 2024
Completion
Nov 4, 2024
Last update
Nov 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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