NCT04872218: ATARI

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

Completed Phase 2 Last updated 27 November 2024

What this trial tests

Phase 2 trial testing Abatacept in Peanut Allergy in 14 participants. Completed in 4 November 2024.

Timeline

1 March 2022

Primary endpoint
10 May 2024

4 November 2024

Quick facts

Lead sponsor	Philippe Bégin
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	14
Start date	1 March 2022
Primary completion	10 May 2024
Estimated completion	4 November 2024
Sites	1 location across Canada

Drugs / interventions tested

• Abatacept (abatacept) — full drug profile →
• Placebo
• Peanut oral immunotherapy — full drug profile →

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

Philippe Bégin — full company profile →

Who can join

Adults 14 to 50, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feast for thought: A comprehensive review of food allergy 2021-2023.
   Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
2. The role of biologics in pediatric food allergy and eosinophilic gastrointestinal disorders.
   Sindher SB, Barshow S, Tirumalasetty J, Arasi S, et al · · 2023 · cited 24× · PMID 36872039 · DOI 10.1016/j.jaci.2023.01.007
3. Treatment of food allergy: Oral immunotherapy, biologics, and beyond.
   Sindher SB, Hillier C, Anderson B, Long A, et al · · 2023 · cited 22× · PMID 37100276 · DOI 10.1016/j.anai.2023.04.023
4. The Role of Biologics in the Treatment of Food Allergy.
   Sindher SB, Fiocchi A, Zuberbier T, Arasi S, et al · · 2024 · cited 21× · PMID 38013157 · DOI 10.1016/j.jaip.2023.11.032
5. Targeting type 2 immunity and the future of food allergy treatment.
   Berin MC. · · 2023 · cited 21× · PMID 36880703 · DOI 10.1084/jem.20221104
6. Contribution of T cell subsets to different food allergic diseases.
   Hung L, Zientara B, Berin MC. · · 2024 · cited 8× · PMID 39054597 · DOI 10.1111/imr.13368
7. Peanut oral immunotherapy: current trends in clinical trials.
   Reinwald S, Rolland JM, O'Hehir RE, van Zelm MC. · · 2022 · cited 8× · PMID 35919493 · DOI 10.1093/immadv/ltac004
8. Transitioning peanut oral immunotherapy to clinical practice.
   Lazizi S, Labrosse R, Graham F. · · 2022 · cited 7× · PMID 36092278 · DOI 10.3389/falgy.2022.974250