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

Study Purpose

This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05440643
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ALK-Abelló A/S
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Edwin Kim, MD
Principal Investigator Affiliation	University of North Carolina
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy

Additional Details

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; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents; part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children; part 3 will evaluate the efficacy of 2 maintenance doses of the SLIT-tablet primarily in adolescents and children; a small number of adults may also be included. 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 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. In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo. The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.

Arms & Interventions