A Phase I, Open-label Trial to Assess the Tolerability and Safety of an Up-dosing Regimen With a Once-daily Peanut SLIT-tablet in Adults, Adolescents, and Children With Peanut Allergy

PT-01

This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet.

2022-09-07

2024-10-01

2024-11-01

Recruiting

Early phase I

90

Inclusion criteria apply to both part 1 and part 2 of the trial, unless otherwise specified. 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 * Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food * Peanut-specific serum IgE ≥ 0.7 kUA/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 double-blind, placebo-controlled food challenge * Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening double-blind, placebo-controlled food challenge 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) * Part 1 and 2: All subjects ≥ 5 years old with FEV1 or PEFR \< 70% of predicted value at enrollment * Part 2: 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2023-11-15