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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05440643
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ALK-Abelló A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Edwin Kim, MD
Principal Investigator Affiliation University of North Carolina
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

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).

Arms & Interventions

Arms

Experimental: Cohort 1

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Experimental: Cohort 2

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Experimental: Cohort 3

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Experimental: Cohort 4

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Experimental: Cohort 5

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Experimental: Cohort 6

Adults and adolescents - UDR with once daily peanut SLIT-tablet

Experimental: Cohort 7

Adolescents - UDR with once daily peanut SLIT-tablet

Experimental: Cohort 8

Children - UDR with once daily peanut SLIT-tablet

Experimental: Cohort 9

Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet

Experimental: Cohort 10

Highly sensitized Children - UDR with once daily peanut SLIT-tablet

Interventions

Biological: - Peanut SLIT-tablet

Peanut extract

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Site Contact

Kim Norris

norriskd@archildrens.org

+45 45747576

Allergy & Asthma Clinical Research, Walnut Creek, California

Status

Recruiting

Address

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598

Site Contact

Abel Garcia

agarcia@bayareaallergy.com

+45 45747576

Quality Research of South Florida, Hialeah, Florida

Status

Active, not recruiting

Address

Quality Research of South Florida

Hialeah, Florida, 33016

MOORE-PH Dermatology - Clinical Research, Tampa, Florida

Status

Recruiting

Address

MOORE-PH Dermatology - Clinical Research

Tampa, Florida, 33609

Site Contact

Michelle Orzechowski

morzechowski@moorecr.com

813-948-7550

Tampa, Florida

Status

Recruiting

Address

USF Asthma Allergy and Immunology Clinical Research Unit

Tampa, Florida, 33609

Site Contact

Patricia Michelle Twitmyer

mtwitmyer@usf.edu

+45 45747576

Chicago, Illinois

Status

Recruiting

Address

Ann Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611-2605

Site Contact

Michelle Catalano

mcatalano@luriechildrens.org

+45 45747576

Sneeze, Wheeze, & Itch Associates, LLC, Normal, Illinois

Status

Recruiting

Address

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761

Site Contact

Stephanie Oliver

stephanieoliver@asthma2.com

309-452-0995

Family Allergy Asthma Research Institute, Louisville, Kentucky

Status

Recruiting

Address

Family Allergy Asthma Research Institute

Louisville, Kentucky, 40215-1176

Site Contact

Becky Whitehead

bwhitehead@familyallergy.com

+45 45747576

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287-0005

Site Contact

Anania Nicholas

nanania1@jhmi.edu

+45 45747576

Boston Food Allergy Center, Boston, Massachusetts

Status

Recruiting

Address

Boston Food Allergy Center

Boston, Massachusetts, 02111

Site Contact

Rachel Solecki

research@bfac.org

857-370-7200

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Jannat Gill

jgill0@mgh.harvard.edu

617-643-8683

Allergy Partners of NJ, Ocean City, New Jersey

Status

Withdrawn

Address

Allergy Partners of NJ

Ocean City, New Jersey, 07712

Northwell Health, Great Neck, New York

Status

Recruiting

Address

Northwell Health

Great Neck, New York, 11021

Site Contact

Annica Bryson

abryson1@northwell.edu

+45 45747576

University of North Carolina, Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599

Site Contact

Lauren Herhily

lekoch@email.unc.edu

919-962-4406

Aventiv research, Inc, Columbus, Ohio

Status

Recruiting

Address

Aventiv research, Inc

Columbus, Ohio, 43212

Western Sky Medical Research, El Paso, Texas

Status

Recruiting

Address

Western Sky Medical Research

El Paso, Texas, 79903

Site Contact

Catherine Posey-Sariñana

catposey@westernskymed.com

915-544-2557

International Sites

Halton Pediatric Allergy, Burlington, Ontario, Canada

Status

Recruiting

Address

Halton Pediatric Allergy

Burlington, Ontario, L7L 6W6

Site Contact

Mariam A Hanna, MD

mariam.hanna@medportal.ca

905-315-9543

Québec, Canada

Status

Recruiting

Address

Clinique Specialisee en Allergie de la Capitale

Québec, , G1V 4W2

Site Contact

Audrey Gaeck, SC

agaeck@csacqc.ca

418.659.7741

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