PT-01 Study

Study Description:

This is a phase I, open-label, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge (DBPCFC). The trial is conducted in 2 parts; part 1 will determine the entry dose of the UDR in adults and adolescents and part 2 will characterize the tolerability of the UDR in adults, adolescents and children. The trial will consist of up to 10 cohorts.

Study Eligibility: 

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 DBPCFC
• Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC

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
• 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
• Allergic symptoms in reaction to the placebo part of the screening DBPCF
• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC
• 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