Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05440643
Other study ID # PT-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05667610 - Immune-supportive Diet and Gut Permeability in Allergic Children N/A
Terminated NCT03849079 - Validation of the HYPONUT Product N/A
Completed NCT02979600 - Clinical and Biological Efficacy of Peanut Oral Immunotherapy N/A
Completed NCT01955109 - Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children Phase 2
Completed NCT01950533 - The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
Recruiting NCT04415593 - High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety N/A
Active, not recruiting NCT04511494 - Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT N/A
Active, not recruiting NCT04887441 - Allergology: Information, Data and Knowledge Organization
Active, not recruiting NCT04881773 - Oral Low Doses Tolerance INduction Study for Peanuts
Completed NCT03682770 - Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy) Phase 2
Terminated NCT03703791 - Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents Phase 3
Completed NCT02916446 - Safety Study of Viaskin Peanut to Treat Peanut Allergy Phase 3
Active, not recruiting NCT02402231 - Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy Phase 2
Completed NCT03337542 - AR101 Real-World Open-Label Extension Study Phase 3
Recruiting NCT05476497 - Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects Phase 1
Completed NCT03648320 - The Grown Up Peanut Immunotherapy Study N/A
Completed NCT03292484 - Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) Phase 3
Completed NCT03852342 - Reactive Doses and Times During Oral Food Challenge to Peanut
Recruiting NCT05138757 - Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy Phase 1/Phase 2
Completed NCT03352726 - A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects Phase 1