NCT04872218

Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Philippe Bégin · Academic / Other
• Sex: All
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	Abatacept	24 week treatment of IV abatacept following recommended dosages from the monograph
DRUG	Placebo	24 week treatment of IV placebo following recommended dosages from the abatacept 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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-05-10
• Completion: 2024-11-04
• First posted: 2021-05-04
• Last updated: 2024-11-27

Locations

1 site across 1 country: Canada