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

Peanut Allergy Clinical Trial

Official title:
A Phase I, Open-label Trial to Assess the Tolerability and Safety of an Up-dosing Regimen With a Once-daily Peanut SLIT-tablet in Adults, Adolescents, and Children With Peanut Allergy

Clinical Trial Summary

This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet.

Clinical Trial Description

This is a phase I, open-label, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 2 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents and part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children. 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 increasing 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. The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05440643
Study type Interventional
Source ALK-Abelló A/S
Contact Clinical Project Manager
Phone +45 45747576
Email clinicaltrials@alk.net
Status Recruiting
Phase Phase 1
Start date September 7, 2022
Completion date November 2024
View Details
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