NCT05440643

Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy

A Phase I/II Trial in 3 Parts Assessing the Safety, Tolerability, and Efficacy of a Once-daily Peanut Sublingual Immunotherapy (SLIT) Tablet in Adults, Adolescents, and Children With Peanut Allergy

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.

Detailed description

This is a phase I/II, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 3 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents; part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children; part 3 will evaluate the efficacy of 2 maintenance doses of the SLIT-tablet primarily in adolescents and children; a small number of adults may also be included. Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study. In part 1, subjects will receive a peanut SLIT-tablet with one of five doses once daily for 2 weeks. In part 2, subjects will receive a series of increasing doses of the peanut SLIT-tablet, where each dose is taken once daily for 2 weeks. The entry dose for the up-dosing regimen will be determined from part 1. In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo. The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Peanut SLIT-tablet	Peanut extract
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-09-07
• Primary completion: 2026-03-10
• Completion: 2026-04-01
• First posted: 2022-07-01
• Last updated: 2026-03-18

Locations

42 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study