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

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

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 Type: Interventional (Clinical Trial)
Estimated Enrollment: 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date: July 2021
Estimated Primary Completion Date: July 2022
Estimated Study Completion Date: January 2023

Arm:
- Experimental: Abatacept
- Placebo Comparator: Placebo

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