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

May 13, 2024 updated by: ALK-Abelló A/S

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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. 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).

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Québec, Canada, G1V 4W2
        • Recruiting
        • Clinique Specialisee en Allergie de la Capitale
        • Contact:
        • Principal Investigator:
          • Remi Gagnon, MD
    • Ontario
      • Burlington, Ontario, Canada, L7L 6W6
        • Recruiting
        • Halton Pediatric Allergy
        • Contact:
        • Principal Investigator:
          • Douglas P Mack, MD
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stacie Jones, MD
        • Sub-Investigator:
          • Amy Scurlock, MD
        • Sub-Investigator:
          • Robbie Pesek, MD
    • California
    • Florida
      • Hialeah, Florida, United States, 33016
        • Active, not recruiting
        • Quality Research of South Florida
      • Tampa, Florida, United States, 33609
        • Recruiting
        • MOORE-PH Dermatology - Clinical Research
        • Contact:
        • Principal Investigator:
          • Julian Melamed, MD
        • Sub-Investigator:
          • Michael Tharp, MD
        • Sub-Investigator:
          • Scott Miller, MD
      • Tampa, Florida, United States, 33609
        • Recruiting
        • USF Asthma Allergy and Immunology Clinical Research Unit
        • Principal Investigator:
          • Thomas Casale, MD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Principal Investigator:
          • James Moy, MD
        • Contact:
      • Chicago, Illinois, United States, 60611-2605
        • Recruiting
        • Ann Robert H. Lurie Childrens Hospital of Chicago
        • Contact:
        • Principal Investigator:
          • Abigail T Lang, MD
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Sneeze, Wheeze, & Itch Associates, LLC
        • Contact:
        • Principal Investigator:
          • Dareen Siri, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40215-1176
        • Recruiting
        • Family Allergy Asthma Research Institute
        • Contact:
        • Principal Investigator:
          • James Sublett, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287-0005
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Robert Wood, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Wayne G Shreffler, MD
        • Contact:
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Boston Food Allergy Center
        • Principal Investigator:
          • John Leung, MD
        • Sub-Investigator:
          • Gary Trey, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Ian MD Slack
    • New Jersey
      • Ocean City, New Jersey, United States, 07712
        • Withdrawn
        • Allergy Partners of NJ
    • New York
      • Great Neck, New York, United States, 11021
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Edwin Kim, MD
    • Ohio
    • Texas
      • El Paso, Texas, United States, 79903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: 2 weeks per dose
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
Time Frame: 2 weeks per dose
Assessment of the safety of the peanut SLIT-tablet in peanut allergic subjects
2 weeks per dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Parexel

Investigators

  • Principal Investigator: Edwin Kim, MD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

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 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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