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

Primary Purpose

Peanut Allergy

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Peanut SLIT-tablet
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Peanut allergy, Children, Adolescent, Adult

Eligibility Criteria

4 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 18 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

Sites / Locations

  • Arkansas Children's HospitalRecruiting
  • Allergy & Asthma Clinical ResearchRecruiting
  • Quality Research of South Florida
  • MOORE-PH Dermatology - Clinical ResearchRecruiting
  • USF Asthma Allergy and Immunology Clinical Research UnitRecruiting
  • Ann Robert H. Lurie Childrens Hospital of ChicagoRecruiting
  • Sneeze, Wheeze, & Itch Associates, LLCRecruiting
  • Family Allergy Asthma Research InstituteRecruiting
  • Johns Hopkins University School of MedicineRecruiting
  • Boston Food Allergy CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Allergy Partners of NJ
  • Northwell HealthRecruiting
  • University of North CarolinaRecruiting
  • Aventiv research, IncRecruiting
  • Western Sky Medical ResearchRecruiting
  • Halton Pediatric AllergyRecruiting
  • Clinique Specialisee en Allergie de la CapitaleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

Cohort 9

Cohort 10

Arm Description

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Adults and adolescents - UDR with once daily peanut SLIT-tablet

Adolescents - UDR with once daily peanut SLIT-tablet

Children - UDR with once daily peanut SLIT-tablet

Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet

Highly sensitized Children - UDR with once daily peanut SLIT-tablet

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Treatment-emergent adverse events
Assessment of the safety of the peanut SLIT-tablet in peanut allergic subjects

Full Information

First Posted
June 17, 2022
Last Updated
September 15, 2023
Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT05440643
Brief Title
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
Collaborators
Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut allergy, Children, Adolescent, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
Adults and adolescents - UDR with once daily peanut SLIT-tablet
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
Adolescents - UDR with once daily peanut SLIT-tablet
Arm Title
Cohort 8
Arm Type
Experimental
Arm Description
Children - UDR with once daily peanut SLIT-tablet
Arm Title
Cohort 9
Arm Type
Experimental
Arm Description
Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet
Arm Title
Cohort 10
Arm Type
Experimental
Arm Description
Highly sensitized Children - UDR with once daily peanut SLIT-tablet
Intervention Type
Biological
Intervention Name(s)
Peanut SLIT-tablet
Intervention Description
Peanut extract
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
2 weeks per dose
Secondary Outcome Measure Information:
Title
Treatment-emergent adverse events
Description
Assessment of the safety of the peanut SLIT-tablet in peanut allergic subjects
Time Frame
2 weeks per dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
+45 45747576
Email
clinicaltrials@alk.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Kim, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Norris
Email
norriskd@archildrens.org
First Name & Middle Initial & Last Name & Degree
Cassandra Thomas
Email
thomasc1@archildrens.org
First Name & Middle Initial & Last Name & Degree
Stacie Jones, MD
First Name & Middle Initial & Last Name & Degree
Amy Scurlock, MD
First Name & Middle Initial & Last Name & Degree
Robbie Pesek, MD
Facility Name
Allergy & Asthma Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Garcia
Email
agarcia@bayareaallergy.com
First Name & Middle Initial & Last Name & Degree
Melanie Barral
Email
mbarrall@bayareaallergy.com
First Name & Middle Initial & Last Name & Degree
Roy Orden, MD
Facility Name
Quality Research of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MOORE-PH Dermatology - Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Orzechowski
Phone
813-948-7550
Email
morzechowski@moorecr.com
First Name & Middle Initial & Last Name & Degree
Julian Melamed, MD
First Name & Middle Initial & Last Name & Degree
Michael Tharp, MD
First Name & Middle Initial & Last Name & Degree
Scott Miller, MD
Facility Name
USF Asthma Allergy and Immunology Clinical Research Unit
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Michelle Twitmyer
Email
mtwitmyer@usf.edu
First Name & Middle Initial & Last Name & Degree
Catherine Smith
Email
catherinesmith@usf.edu
First Name & Middle Initial & Last Name & Degree
Thomas Casale, MD
Facility Name
Ann Robert H. Lurie Childrens Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Catalano
Email
mcatalano@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Abigail T Lang, MD
Facility Name
Sneeze, Wheeze, & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Oliver
Phone
309-452-0995
Email
stephanieoliver@asthma2.com
First Name & Middle Initial & Last Name & Degree
Dareen Siri, MD
Facility Name
Family Allergy Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215-1176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Whitehead
Email
bwhitehead@familyallergy.com
First Name & Middle Initial & Last Name & Degree
James Sublett, MD
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0005
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anania Nicholas
Email
nanania1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Robert Wood, MD
Facility Name
Boston Food Allergy Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Cunningham
Phone
857-370-7200
Email
research@bfac.org
First Name & Middle Initial & Last Name & Degree
John Leung, MD
First Name & Middle Initial & Last Name & Degree
Gary Trey, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jannat Gill
Phone
617-643-8683
Email
jgill0@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Wayne G Shreffler, MD
Facility Name
Allergy Partners of NJ
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Individual Site Status
Withdrawn
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annica Bryson
Email
abryson1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Aaqil Ali
Email
aali27@northwell.edu
First Name & Middle Initial & Last Name & Degree
Punita Ponda, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Herhily
Phone
919-962-4406
Email
lekoch@email.unc.edu
First Name & Middle Initial & Last Name & Degree
Edwin Kim, MD
Facility Name
Aventiv research, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheri Price
Email
sheri.price@centricityresearch.com
First Name & Middle Initial & Last Name & Degree
Logan Aldrich
Email
Logan.Aldrich@centricityresearch.com
First Name & Middle Initial & Last Name & Degree
Sridhar Guduri, MD
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Posey-Sariñana
Phone
915-544-2557
Email
catposey@westernskymed.com
First Name & Middle Initial & Last Name & Degree
Laura Herrera
Email
lherrera@westernskymed.com
First Name & Middle Initial & Last Name & Degree
Todd Funkhouser, MD
Facility Name
Halton Pediatric Allergy
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7L 6W6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam A Hanna, MD
Phone
905-315-9543
Email
mariam.hanna@medportal.ca
First Name & Middle Initial & Last Name & Degree
Douglas P Mack, MD
Facility Name
Clinique Specialisee en Allergie de la Capitale
City
Québec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Gaeck, SC
Phone
418.659.7741
Email
agaeck@csacqc.ca
First Name & Middle Initial & Last Name & Degree
Remi Gagnon, MD

12. IPD Sharing Statement

Learn more about this trial

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

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