Status:
ACTIVE_NOT_RECRUITING
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Parexel
Conditions:
Peanut Allergy
Eligibility:
All Genders
4-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
Detailed Description
This is a phase I/II, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 3 parts...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT05440643
Start Date
September 7 2022
End Date
February 1 2026
Last Update
October 1 2025
Active Locations (40)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Children's Hospital of Los Angeles - USC School of Medicine
Los Angeles, California, United States, 90027
3
UCLA - Pediatrics
Los Angeles, California, United States, 90095
4
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304