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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05440643
• Other study ID #: PT-01
• Status: Recruiting
• Phase: Phase 1
• Start date: September 7, 2022
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: ALK-Abelló A/S
• Contact: Clinical Project Manager
• Phone: +45 45747576
• Email: clinicaltrials[@]alk.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

Inclusion criteria apply to both part 1 and part 2 of the trial, unless otherwise specified.

Subjects are eligible to be included in the trial only if all the following criteria apply:

• Part 1: Male or female aged 12 through 65 years (inclusive) on the day of enrollment

• Part 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollment

• Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food

• Peanut-specific serum IgE = 0.7 kUA/L at screening measured at central laboratory

• Skin prick test to peanut = 5 mm at screening

• Cohorts 1-8: Experience dose-limiting symptoms at the 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening double-blind, placebo-controlled food challenge

• Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening double-blind, placebo-controlled food challenge

Subjects are excluded from the trial if any of the following criteria apply:

• Diagnosis or history of eosinophilic esophagitis

• Uncontrolled asthma as defined by the Asthma Control Test questionnaire with a score of 19 or below at enrollment (subjects with a diagnosis of asthma only)

• Part 1 and 2: All subjects = 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment

• Part 2: Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment

• Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed

• History of peanut oral immunotherapy within the last 12 months prior to visit 1

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• Peanut SLIT-tablet
Peanut extract

Locations

Country	Name	City	State
Canada	Halton Pediatric Allergy	Burlington	Ontario
Canada	Clinique Specialisee en Allergie de la Capitale	Québec
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Boston Food Allergy Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Ann Robert H. Lurie Childrens Hospital of Chicago	Chicago	Illinois
United States	Rush University	Chicago	Illinois
United States	Aventiv research, Inc	Columbus	Ohio
United States	Western Sky Medical Research	El Paso	Texas
United States	Northwell Health	Great Neck	New York
United States	Quality Research of South Florida	Hialeah	Florida
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Family Allergy Asthma Research Institute	Louisville	Kentucky
United States	Sneeze, Wheeze, & Itch Associates, LLC	Normal	Illinois
United States	Allergy Partners of NJ	Ocean City	New Jersey
United States	MOORE-PH Dermatology - Clinical Research	Tampa	Florida
United States	USF Asthma Allergy and Immunology Clinical Research Unit	Tampa	Florida
United States	Allergy & Asthma Clinical Research	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
ALK-Abelló A/S	Parexel

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who experience at most moderate local application site reactions after the last peanut SLIT-tablet intake of the dose step (Tolerability)	Assessment of the tolerability of each dose step based on the incidence of local application site reactions (i.e. treatment-related adverse events occurring in close proximity to the application site of the SLIT-tablet with a temporal relationship to tablet administration of the tablet)	2 weeks per dose
Secondary	Treatment-emergent adverse events	Assessment of the safety of the peanut SLIT-tablet in peanut allergic subjects	2 weeks per dose