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Peanut allergy pill shows promise in early trial

NCT ID NCT05440643

Disease control Sponsor: ALK-Abelló A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a daily tablet placed under the tongue (SLIT) containing peanut protein to help people with peanut allergy tolerate small amounts of peanut. The trial included 209 adults, teens, and children ages 4 to 65. Researchers measured how many participants could safely eat 600 mg of peanut protein after 24 weeks of treatment, and tracked side effects like mouth irritation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peanut extract sublingual tablet
What this could lead to
If successful, this daily tablet could help people with peanut allergy tolerate small amounts of peanut, reducing the risk of severe reactions from accidental exposure.
What could go wrong
This is an early-phase trial with only 209 participants, so results may not apply to everyone. Side effects like mouth or throat reactions are common, and the tablet does not cure the allergy—daily use is needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

209 people

The number who actually took part.

Started

Sep 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

KEY INCLUSION CRITERIA: 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 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 KEY EXCLUSION CRITERIA: 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) * 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)

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peanut allergy

Contacts and locations

Locations

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598, United States

  • Allergy Partners of NJ

    Ocean City, New Jersey, 07712, United States

  • Ann Robert H. Lurie Childrens Hospital of Chicago

    Chicago, Illinois, 60611-2605, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Asthma, Allergy and Sinus Center

    White Marsh, Maryland, 21162, United States

  • Aventiv research, Inc

    Columbus, Ohio, 43212, United States

  • BC Children's Hospital

    Vancouver, British Colombia, V5H 3V4, Canada

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

    Houston, Texas, 77030, United States

  • Boston Food Allergy Center

    Boston, Massachusetts, 02111, United States

  • CHU-Saint-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Center for Advance Pediatrics

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

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

    Los Angeles, California, 90027, 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

  • Clinique Specialisee en Allergie de la Capitale

    Québec, G1V 4W2, Canada

  • Eastern Virginia Medical School - Children's Hospital

    San Diego, California, 92123, United States

  • Family Allergy Asthma Research Institute

    Louisville, Kentucky, 40215-1176, United States

  • Halton Pediatric Allergy

    Burlington, Ontario, L7L 6W6, Canada

  • Hamilton Allergy

    Hamilton, Ontario, Canada

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

    New York, New York, 10029, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287-0005, United States

  • MOORE-PH Dermatology - Clinical Research

    Tampa, Florida, 33609, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre (MUHC) - Research Institute (RI-MUHC)

    Montreal, Quebec, H3H 2R9, Canada

  • NYU Langone Health - Fink Children's Ambulatory Care Center

    New York, New York, 10016, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Ottawa Allergy Research Corporation

    Ottawa, Ontario, K1H 1E4, Canada

  • Peninsula Research Associates (PRA)

    Rolling Hills Estates, California, 90274, United States

  • Quality Research of South Florida

    Hialeah, Florida, 33016, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • Sneeze, Wheeze, & Itch Associates, LLC

    Normal, Illinois, 61761, United States

  • Stanford University - Lucile Packard Children's Hospital

    Palo Alto, California, 94304, United States

  • The Children's Hospital Foundation of Manitoba

    Winnipeg, Manitoba, R3A 1M3, Canada

  • The Hospital for Sick Children, Toronto

    Toronto, Ontario, M5G 1E8, Canada

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UCLA - Pediatrics

    Los Angeles, California, 90095, United States

  • USF Asthma Allergy and Immunology Clinical Research Unit

    Tampa, Florida, 33609, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • Velocity Clinical Research - Lafayette

    Lafayette, Louisiana, 70508, United States

  • Western Sky Medical Research

    El Paso, Texas, 79903, United States

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