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Peanut SLIT-tablet treatment for peanut allergy

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

Phase1; Phase2 Interventional ALK-Abelló A/S · NCT05440643

This study is testing a new peanut allergy tablet to see if it can help people aged 4 to 65 safely tolerate peanuts better than a placebo.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment192 (estimated)
Ages4 Years to 65 Years
SexAll
SponsorALK-Abelló A/S Industry-sponsored
Drugs / interventionsimmunotherapy
Locations42 sites (Little Rock, Arkansas and 41 other locations)
Trial IDNCT05440643 on ClinicalTrials.gov

What this trial studies

This clinical research investigates the safety, tolerability, and efficacy of a peanut sublingual immunotherapy (SLIT) tablet in individuals aged 4 to 65 with peanut allergies. The study is divided into three parts: the first part determines the appropriate entry dose for the up-dosing regimen in adults and adolescents, the second part assesses the tolerability of increasing doses in all age groups, and the third part evaluates the efficacy of two maintenance doses primarily in adolescents and children. Participants will receive either the SLIT-tablet or a placebo over a series of increasing doses followed by maintenance doses over several weeks.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 4 to 65 with a documented history of peanut allergy and specific IgE levels.

Not a fit: Patients who do not have a confirmed IgE-mediated allergic reaction to peanuts or are outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce allergic reactions to peanuts in affected individuals.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Little Rock, Arkansas and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peanut AllergyPeanut allergyChildrenAdolescentAdult
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.