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

STUDY OVERVIEW

ALK-Abelló A/S is sponsoring this phase I, open-label, dose-escalation study evaluates the safety and tolerability of a peanut SLIT-tablet in subjects with confirmed peanut allergy. Conducted in two parts, part 1 determines the initial dose in adults and adolescents, while part 2 assesses the tolerability of increasing doses in adults, adolescents, and children. Participants will receive 9 doses covering a 4000-fold increase. Part 1 involves taking one of five doses daily for 2 weeks, and part 2 involves taking increasing doses daily for 2 weeks based on part 1 results. The trial includes up to 10 cohorts, with cohorts 1-5 in part 1 and cohorts 6-10 in part 2.

STUDY GOALS

The goal of this study is to evaluate the safety and tolerability of a peanut SLIT-tablet in individuals with confirmed peanut allergy.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA

  • Part 1: Male or female, aged 12-65 years.

  • Part 2: Male or female, aged 4-65 years.

    • Documented history of an IgE-mediated allergic reaction to peanuts.

    • Peanut-specific serum IgE ≥ 0.7 kUA/L at screening.

    • Positive 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 peanut protein challenge dose.

  • Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg peanut protein challenge dose.

exclusion criteria

  • History or diagnosis of eosinophilic esophagitis.

  • Uncontrolled asthma (Asthma Control Test score ≤ 19).

  • Part 1 and 2: Subjects aged 5 and older with FEV1 or PEFR < 70% of predicted value.

  • Part 2: 4-year-olds with recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks within 3 months before enrollment.

  • Currently up-dosing with any allergy immunotherapy product (maintenance dose of non-peanut subcutaneous immunotherapy allowed).

  • History of peanut oral immunotherapy in the past 12 months.

For more information, visit ClinicalTrials.gov.