ACTIVE_NOT_RECRUITING

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

Conditions

Peanut Allergy Children Adolescent Adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-09-07

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05440643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization * Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food * Peanut-specific serum IgE ≥ 0.7 kU/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 DBPCFC Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC	* 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) * All subjects ≥ 5 years old with FEV1 or PEFR \< 70% of predicted value at enrollment 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 * Chronic or acute oral inflammation at enrollment * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * Currently using any prohibited medication on the list of prohibited medication * Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screening DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC * History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC * Part 1 and 2: Asthma according to below criteria: * Severe asthma as per the current GINA guidelines * Uncontrolled or poorly controlled asthma as per the current GINA guidelines * Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids) * History of 2 or more systemic corticosteroid courses within 6 months of screening * Prior intubation/mechanical ventilation for asthma * Emergency room visit or hospitalization for asthma in the 12 months prior to screening * Any history of a life-threatening asthma attack * Part 3: Asthma fulfilling the below criteria: * History of 2 or more systemic corticosteroid courses within 6 months of screening * Prior intubation/mechanical ventilation for asthma * Emergency room visit or hospitalization for asthma in the 12 months prior to screening * Any history of a life-threatening asthma attack * (US only) Severe asthma as per the current GINA guidelines * (US only) Uncontrolled or poorly controlled asthma as per the current GINA guidelines * (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)

Inclusion Criteria

Exclusion Criteria

* 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 Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization
* Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
* Peanut-specific serum IgE ≥ 0.7 kU/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 DBPCFC Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC

* 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)
* All subjects ≥ 5 years old with FEV1 or PEFR \< 70% of predicted value at enrollment 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
* Chronic or acute oral inflammation at enrollment
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* Currently using any prohibited medication on the list of prohibited medication
* Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screening DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC
* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC
* Part 1 and 2: Asthma according to below criteria:
* Severe asthma as per the current GINA guidelines
* Uncontrolled or poorly controlled asthma as per the current GINA guidelines
* Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids)
* History of 2 or more systemic corticosteroid courses within 6 months of screening
* Prior intubation/mechanical ventilation for asthma
* Emergency room visit or hospitalization for asthma in the 12 months prior to screening
* Any history of a life-threatening asthma attack
* Part 3: Asthma fulfilling the below criteria:
* History of 2 or more systemic corticosteroid courses within 6 months of screening
* Prior intubation/mechanical ventilation for asthma
* Emergency room visit or hospitalization for asthma in the 12 months prior to screening
* Any history of a life-threatening asthma attack
* (US only) Severe asthma as per the current GINA guidelines
* (US only) Uncontrolled or poorly controlled asthma as per the current GINA guidelines
* (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)

Contacts and Locations

Principal Investigator

Edwin Kim, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina

Study Locations (Sites)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

Children's Hospital of Los Angeles - USC School of Medicine

Los Angeles, California, 90027

United States

UCLA - Pediatrics

Los Angeles, California, 90095

United States

Stanford University - Lucile Packard Children's Hospital

Palo Alto, California, 94304

United States

Peninsula Research Associates (PRA)

Rolling Hills Estates, California, 90274

United States

Eastern Virginia Medical School - Children's Hospital

San Diego, California, 92123

United States

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Quality Research of South Florida

Hialeah, Florida, 33016

United States

MOORE-PH Dermatology - Clinical Research

Tampa, Florida, 33609

United States

USF Asthma Allergy and Immunology Clinical Research Unit

Tampa, Florida, 33609

United States

Center for Advance Pediatrics

Atlanta, Georgia, 30329

United States

Ann Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611-2605

United States

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761

United States

Family Allergy Asthma Research Institute

Louisville, Kentucky, 40215-1176

United States

Velocity Clinical Research - Lafayette

Lafayette, Louisiana, 70508

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287-0005

United States

Asthma, Allergy and Sinus Center

White Marsh, Maryland, 21162

United States

Boston Food Allergy Center

Boston, Massachusetts, 02111

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Northwell Health

Great Neck, New York, 11021

United States

NYU Langone Health - Fink Children's Ambulatory Care Center

New York, New York, 10016

United States

Icahn School of Medicine at Mt. Sinai, Pediatric Allergy, Kravis Children Hospital

New York, New York, 10029

United States

University of North Carolina

Chapel Hill, North Carolina, 27599

United States

Aventiv research, Inc

Columbus, Ohio, 43212

United States

Children's Hospital of Philadephia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburg of UPMC - Immunology and Rheumatology

Pittsburgh, Pennsylvania, 15224

United States

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Western Sky Medical Research

El Paso, Texas, 79903

United States

Baylor College of Medicine (BCM) Texas Children's Hospital Pediatrics and Immunology

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: ALK-Abelló A/S

Edwin Kim, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-07

Study Completion Date2026-02

Study Record Updates

Study Start Date2022-09-07

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

Peanut allergy
Children
Adolescent
Adult

Additional Relevant MeSH Terms

Peanut Allergy