Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
- Registration Number
- NCT05440643
- Lead Sponsor
- ALK-Abellรณ A/S
- Brief Summary
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Cohort 5 Peanut SLIT-tablet Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Part 2: Cohort 8 Peanut SLIT-tablet Children - UDR with once daily peanut SLIT-tablet Part 3: Maintenance B Peanut SLIT-tablet UDR B + maintenance dose B Part 2: Cohort 7 Peanut SLIT-tablet Adolescents - UDR with once daily peanut SLIT-tablet Part 3: Maintenance A Peanut SLIT-tablet UDR A + maintenance dose A Part 1: Cohort 1 Peanut SLIT-tablet Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Part 1: Cohort 2 Peanut SLIT-tablet Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Part 1: Cohort 3 Peanut SLIT-tablet Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Part 1: Cohort 4 Peanut SLIT-tablet Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks Part 2: Cohort 6 Peanut SLIT-tablet Adults - UDR with once daily peanut SLIT-tablet Part 2: Cohort 9 Peanut SLIT-tablet Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet Part 2: Cohort 10 Peanut SLIT-tablet Highly sensitized Children - UDR with once daily peanut SLIT-tablet Part 3: Placebo Placebo Placebo UDR + placebo maintenance
- Primary Outcome Measures
Name Time Method Part 1 and 2: Dose tolerability response rate 2 weeks per dose 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.
Part 3: TD-600 response rate After 24 weeks of maintenance treatment, up to 48 weeks. 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.
- Secondary Outcome Measures
Name Time Method Part 1, 2 and 3: Treatment-emergent adverse events 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. 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 3: TD-300 response rate After 24 weeks of maintenance treatment, up to 48 weeks. 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.
Part 3: TD-1000 response rate After 24 weeks of maintenance treatment, up to 48 weeks. 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.
Part 3: TD-2000 response rate After 24 weeks of maintenance treatment, up to 48 weeks. 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.
Part 3: Maximum tolerated dose of peanut protein during DBPCFC At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks. The highest single challenge dose of peanut protein that a subject can consume without experiencing dose-limiting symptoms during the DBPCFC.
Part 3: Maximum severity of symptoms at each challenge dose of peanut protein during DBPCFC At screening, 1 - 3 weeks, and after 24 weeks of maintenance treatment, up to 48 weeks. 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.
Part 3: Response rate - use of epinephrine as rescue medication during exit DBPCFC After 24 weeks of maintenance treatment, up to 48 weeks. The response rate is defined as the percentage of subjects that receive epinephrine as rescue medication during the exit DBPCFC.
Trial Locations
- Locations (26)
Arkansas Children's Hospital
๐บ๐ธLittle Rock, Arkansas, United States
Peninsula Research Associates (PRA)
๐บ๐ธRolling Hills Estates, California, United States
Allergy & Asthma Clinical Research
๐บ๐ธWalnut Creek, California, United States
Quality Research of South Florida
๐บ๐ธHialeah, Florida, United States
MOORE-PH Dermatology - Clinical Research
๐บ๐ธTampa, Florida, United States
USF Asthma Allergy and Immunology Clinical Research Unit
๐บ๐ธTampa, Florida, United States
Ann Robert H. Lurie Childrens Hospital of Chicago
๐บ๐ธChicago, Illinois, United States
Rush University
๐บ๐ธChicago, Illinois, United States
Sneeze, Wheeze, & Itch Associates, LLC
๐บ๐ธNormal, Illinois, United States
Family Allergy Asthma Research Institute
๐บ๐ธLouisville, Kentucky, United States
Velocity Clinical Research - Lafayette
๐บ๐ธLafayette, Louisiana, United States
Johns Hopkins University School of Medicine
๐บ๐ธBaltimore, Maryland, United States
Asthma, Allergy and Sinus Center
๐บ๐ธWhite Marsh, Maryland, United States
Boston Food Allergy Center
๐บ๐ธBoston, Massachusetts, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Allergy Partners of NJ
๐บ๐ธOcean City, New Jersey, United States
Northwell Health
๐บ๐ธGreat Neck, New York, United States
University of North Carolina
๐บ๐ธChapel Hill, North Carolina, United States
Aventiv research, Inc
๐บ๐ธColumbus, Ohio, United States
Western Sky Medical Research
๐บ๐ธEl Paso, Texas, United States
The Children's Hospital Foundation of Manitoba
๐จ๐ฆWinnipeg, Manitoba, Canada
Halton Pediatric Allergy
๐จ๐ฆBurlington, Ontario, Canada
Hamilton Allergy
๐จ๐ฆHamilton, Ontario, Canada
The Hospital for Sick Children, Toronto
๐จ๐ฆToronto, Ontario, Canada
Clinique Specialisee en Allergie de la Capitale
๐จ๐ฆQuรฉbec, Canada
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