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

A Phase I/II Trial in 3 Parts Assessing the Safety, Tolerability, and Efficacy of a Once-daily Peanut Sublingual Immunotherapy (SLIT) Tablet in Adults, Adolescents, and Children With Peanut Allergy

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

Study Overview

• Status: Completed
• Conditions: Peanut Allergy
• Intervention / Treatment: Other: Placebo; Biological: Peanut SLIT-tablet

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; 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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4W2
    • Clinique Spécialisée en Allergie de la Capitale
  • British Colombia
    • Vancouver, British Colombia, Canada, V5H 3V4
      • BC Children's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • The Children's Hospital Foundation of Manitoba
  • Ontario
    • Burlington, Ontario, Canada, L7L 6W6
      • Halton Pediatric Allergy
    • Hamilton, Ontario, Canada
      • Hamilton Allergy
    • Ottawa, Ontario, Canada, K1H 1E4
      • Ottawa Allergy Research Corporation
    • Toronto, Ontario, Canada, M5G 1E8
      • The Hospital for Sick Children, Toronto
  • Quebec
    • Montreal, Quebec, Canada, H3H 2R9
      • McGill University Health Centre (MUHC) - Research Institute (RI-MUHC)
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU-Saint-Justine
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles - USC School of Medicine
    • Los Angeles, California, United States, 90095
      • UCLA - Pediatrics
    • Palo Alto, California, United States, 94304
      • Stanford University - Lucile Packard Children's Hospital
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates (PRA)
    • San Diego, California, United States, 92123
      • Eastern Virginia Medical School - Children's Hospital
    • Walnut Creek, California, United States, 94598
      • Allergy & Asthma Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Florida
    • Hialeah, Florida, United States, 33016
      • Quality Research of South Florida
    • Tampa, Florida, United States, 33609
      • MOORE-PH Dermatology - Clinical Research
    • Tampa, Florida, United States, 33609
      • USF Asthma Allergy and Immunology Clinical Research Unit
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Center for Advance Pediatrics
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Chicago, Illinois, United States, 60611-2605
      • Ann Robert H. Lurie Childrens Hospital of Chicago
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, & Itch Associates, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40215-1176
      • Family Allergy Asthma Research Institute
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research - Lafayette
  • Maryland
    • Baltimore, Maryland, United States, 21287-0005
      • Johns Hopkins University School of Medicine
    • White Marsh, Maryland, United States, 21162
      • Asthma, Allergy and Sinus Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Boston Food Allergy Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Allergy Partners of NJ
  • New York
    • Great Neck, New York, United States, 11021
      • Northwell Health
    • New York, New York, United States, 10016
      • NYU Langone Health - Fink Children's Ambulatory Care Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai, Pediatric Allergy, Kravis Children Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Aventiv research, Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadephia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburg of UPMC - Immunology and Rheumatology
  • Texas
    • Dallas, Texas, United States, 75390
      • The University of Texas Southwestern Medical Center
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine (BCM) Texas Children's Hospital Pediatrics and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Cohort 1; Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 1: Cohort 2; Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 1: Cohort 3; Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 1: Cohort 4; Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 1: Cohort 5; Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 2: Cohort 6; Adults - UDR with once daily peanut SLIT-tablet	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 2: Cohort 7; Adolescents - UDR with once daily peanut SLIT-tablet	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 2: Cohort 8; Children - UDR with once daily peanut SLIT-tablet	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 2: Cohort 9; Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 2: Cohort 10; Highly sensitized Children - UDR with once daily peanut SLIT-tablet	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 3: Maintenance A; UDR A + maintenance dose A	Biological: Peanut SLIT-tablet; Peanut extract
Experimental: Part 3: Maintenance B; UDR B + maintenance dose B	Biological: Peanut SLIT-tablet; Peanut extract
Placebo Comparator: Part 3: Placebo; Placebo UDR + placebo maintenance	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Dose tolerability response rate	The dose tolerability response rate is defined as the percentage of subjects who experience at most moderate local application site reactions after the last peanut SLIT-tablet intake of the dose step. Local application site reactions are treatment-related adverse events occurring in close proximity to the application site of the SLIT-tablet with a temporal relationship to tablet administration.	2 weeks per dose
Part 3: TD-600 response rate	The TD (tolerated dose)-600 response rate is defined as the percentage of subjects able to consume 600 mg (1044 mg cumulative) peanut protein without dose-limiting symptoms at the exit double-blind placebo-controlled food challenge (DBPCFC) after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.	After 24 weeks of maintenance treatment, up to 48 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1, 2 and 3: Treatment-emergent adverse events	An adverse event is any untoward medical occurrence in a clinical trial subject and which does not necessarily have a causal relationship with the administered investigational medicinal product (IMP). A treatment-emergent adverse event has a start date on or after the time of first IMP intake and no later than 7 days after the last IMP intake.	Part 1 and 2: 2 weeks per dose; Part 3: from first IMP intake to 7 days after last IMP intake, up to 48 weeks.
Part 3: TD-300 response rate	The TD-300 response rate is defined as the percentage of subjects able to consume 300 mg (444 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.	After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-1000 response rate	The TD-1000 response rate is defined as the percentage of subjects able to consume 1000 mg (2044 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.	After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: TD-2000 response rate	The TD-2000 response rate is defined as the percentage of subjects able to consume 2000 mg (4044 mg cumulative) peanut protein without dose-limiting symptoms at the exit DBPCFC after 24 weeks of maintenance treatment. Subjects that do not complete the exit DBPCFC are classified as non-responders.	After 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum tolerated dose of peanut protein during DBPCFC	The highest single challenge dose of peanut protein that a subject can consume without experiencing dose-limiting symptoms during the DBPCFC.	At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Maximum severity of symptoms at each challenge dose of peanut protein during DBPCFC	The highest severity of any symptom experienced at any challenge dose during the DBPCFC. Possible values are 0=none, 1=mild, 2=moderate or 3=severe.	At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks.
Part 3: Response rate - use of epinephrine as rescue medication during exit DBPCFC	The response rate is defined as the percentage of subjects that receive epinephrine as rescue medication during the exit DBPCFC.	After 24 weeks of maintenance treatment, up to 48 weeks.

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Collaborators: Parexel
• Investigators: Principal Investigator: Edwin Kim, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): April 5, 2026

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Children; Adult; Peanut allergy
• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: PT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No