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

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

Detailed Description
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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. The trial is conducted in 2 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents and part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children. Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study. In part 1, subjects will receive a peanut SLIT-tablet with one of five increasing doses once daily for 2 weeks. In part 2, subjects will receive a series of increasing doses of the peanut SLIT-tablet, where each dose is taken once daily for 2 weeks. The entry dose for the up dosing regimen will be determined from part 1. The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10).

Official Title
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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

Conditions
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Peanut Allergy

Intervention / Treatment
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* Biological: Peanut SLIT-tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 2<br>Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 3<br>Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 4<br>Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 5<br>Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 6<br>Adults and adolescents - UDR with once daily peanut SLIT-tablet | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 7<br>Adolescents - UDR with once daily peanut SLIT-tablet | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 8<br>Children - UDR with once daily peanut SLIT-tablet | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 9<br>Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|
| Experimental: Cohort 10<br>Highly sensitized Children - UDR with once daily peanut SLIT-tablet | Biological: Peanut SLIT-tablet<br>* Peanut extract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who experience at most moderate local application site reactions after the last peanut SLIT-tablet intake of the dose step (Tolerability) | Assessment of the tolerability of each dose step based on the incidence of local application site reactions (i.e. treatment-related adverse events occurring in close proximity to the application site of the SLIT-tablet with a temporal relationship to tablet administration of the tablet) | 2 weeks per dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events | Assessment of the safety of the peanut SLIT-tablet in peanut allergic subjects | 2 weeks per dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Peanut allergy, Adolescent, Adult