Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
NCT ID: NCT05440643
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
192 participants
INTERVENTIONAL
2022-09-07
2026-04-30
Brief Summary
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Detailed Description
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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 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.
In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo.
The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: Cohort 4
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Peanut SLIT-tablet
Peanut extract
Part 1: Cohort 5
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Peanut SLIT-tablet
Peanut extract
Part 2: Cohort 6
Adults - UDR with once daily peanut SLIT-tablet
Peanut SLIT-tablet
Peanut extract
Part 2: Cohort 7
Adolescents - UDR with once daily peanut SLIT-tablet
Peanut SLIT-tablet
Peanut extract
Part 2: Cohort 8
Children - UDR with once daily peanut SLIT-tablet
Peanut SLIT-tablet
Peanut extract
Part 2: Cohort 9
Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet
Peanut SLIT-tablet
Peanut extract
Part 2: Cohort 10
Highly sensitized Children - UDR with once daily peanut SLIT-tablet
Peanut SLIT-tablet
Peanut extract
Part 3: Maintenance A
UDR A + maintenance dose A
Peanut SLIT-tablet
Peanut extract
Part 3: Maintenance B
UDR B + maintenance dose B
Peanut SLIT-tablet
Peanut extract
Part 3: Placebo
Placebo UDR + placebo maintenance
Placebo
Placebo
Part 1: Cohort 1
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Peanut SLIT-tablet
Peanut extract
Part 1: Cohort 2
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Peanut SLIT-tablet
Peanut extract
Part 1: Cohort 3
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Peanut SLIT-tablet
Peanut extract
Interventions
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Peanut SLIT-tablet
Peanut extract
Placebo
Placebo
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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)
4 Years
65 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Edwin Kim, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles - USC School of Medicine
Los Angeles, California, United States
UCLA - Pediatrics
Los Angeles, California, United States
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, United States
Peninsula Research Associates (PRA)
Rolling Hills Estates, California, United States
Eastern Virginia Medical School - Children's Hospital
San Diego, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Quality Research of South Florida
Hialeah, Florida, United States
MOORE-PH Dermatology - Clinical Research
Tampa, Florida, United States
USF Asthma Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
Center for Advance Pediatrics
Atlanta, Georgia, United States
Ann Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
Normal, Illinois, United States
Family Allergy Asthma Research Institute
Louisville, Kentucky, United States
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Asthma, Allergy and Sinus Center
White Marsh, Maryland, United States
Boston Food Allergy Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Northwell Health
Great Neck, New York, United States
NYU Langone Health - Fink Children's Ambulatory Care Center
New York, New York, United States
Icahn School of Medicine at Mt. Sinai, Pediatric Allergy, Kravis Children Hospital
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Aventiv research, Inc
Columbus, Ohio, United States
Children's Hospital of Philadephia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburg of UPMC - Immunology and Rheumatology
Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Baylor College of Medicine (BCM) Texas Children's Hospital Pediatrics and Immunology
Houston, Texas, United States
BC Children's Hospital
Vancouver, British Colombia, Canada
The Children's Hospital Foundation of Manitoba
Winnipeg, Manitoba, Canada
Halton Pediatric Allergy
Burlington, Ontario, Canada
Hamilton Allergy
Hamilton, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
The Hospital for Sick Children, Toronto
Toronto, Ontario, Canada
McGill University Health Centre (MUHC) - Research Institute (RI-MUHC)
Montreal, Quebec, Canada
CHU-Saint-Justine
Montreal, Quebec, Canada
Clinique Specialisee en Allergie de la Capitale
Québec, , Canada
Countries
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Other Identifiers
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PT-01
Identifier Type: -
Identifier Source: org_study_id
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