Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Philippe Bégin
Collaborator:
Centre hospitalier de l'Université de Montréal (CHUM)