← Back to Search

Immunotherapy

Peanut SLIT-Tablet for Peanut Allergy

Phase 1
Recruiting
Led By Edward Kim, MS
Research Sponsored by ALK-Abelló A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female aged 4 through 65 years (inclusive) on the day of enrollment for Part 2
Male or female aged 12 through 65 years (inclusive) on the day of enrollment for Part 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks per dose
Awards & highlights

Study Summary

This trial is testing if it's safe to use a peanut allergy tablet.

Who is the study for?
This trial is for individuals aged 4-65 with a documented history of allergic reactions to peanuts, confirmed by specific tests. They must have had symptoms at certain doses during a controlled food challenge. People with uncontrolled asthma, recent peanut immunotherapy, or severe respiratory issues can't participate.Check my eligibility
What is being tested?
The study is examining the safety and how well people tolerate a peanut SLIT-tablet as a treatment for peanut allergies. Participants will receive this tablet under their tongue to see if it helps reduce their allergy symptoms.See study design
What are the potential side effects?
Potential side effects may include itching in the mouth, throat irritation, nausea, stomach pain or discomfort after taking the SLIT-tablet. The severity of these side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 4 and 65 years old.
Select...
I am between 12 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks per dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks per dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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)
Secondary outcome measures
Treatment-emergent adverse events

Trial Design

10Treatment groups
Experimental Treatment
Group I: Cohort 9Experimental Treatment1 Intervention
Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet
Group II: Cohort 8Experimental Treatment1 Intervention
Children - UDR with once daily peanut SLIT-tablet
Group III: Cohort 7Experimental Treatment1 Intervention
Adolescents - UDR with once daily peanut SLIT-tablet
Group IV: Cohort 6Experimental Treatment1 Intervention
Adults and adolescents - UDR with once daily peanut SLIT-tablet
Group V: Cohort 5Experimental Treatment1 Intervention
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Group VI: Cohort 4Experimental Treatment1 Intervention
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Group VII: Cohort 3Experimental Treatment1 Intervention
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Group VIII: Cohort 2Experimental Treatment1 Intervention
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Group IX: Cohort 10Experimental Treatment1 Intervention
Highly sensitized Children - UDR with once daily peanut SLIT-tablet
Group X: Cohort 1Experimental Treatment1 Intervention
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
302 Previous Clinical Trials
100,604 Total Patients Enrolled
ALK-Abelló A/SLead Sponsor
76 Previous Clinical Trials
328,215 Total Patients Enrolled
Syneos HealthOTHER
172 Previous Clinical Trials
68,364 Total Patients Enrolled

Media Library

Peanut SLIT-tablet (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05440643 — Phase 1
Peanut Allergy Research Study Groups: Cohort 9, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 10, Cohort 1, Cohort 2
Peanut Allergy Clinical Trial 2023: Peanut SLIT-tablet Highlights & Side Effects. Trial Name: NCT05440643 — Phase 1
Peanut SLIT-tablet (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05440643 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this experiment?

"Affirmative. Clinicaltrials.gov records suggest that the treatment trial, uploaded on September 7th 2022 and last revised November 21st of this same year, is actively searching for 90 participants from 9 distinct sites."

Answered by AI

Is there a widespread implementation of this research study across American healthcare institutions?

"Currently, 9 locations are enrolling participants for this clinical trial. These sites span from Louisville to Walnut creek and El Paso in addition to several other cities. Prospective volunteers should prioritize the nearest facility so as to reduce their transportation needs if they choose to participate."

Answered by AI

Has the Peanut SLIT-tablet been accepted for use by the U.S Food and Drug Administration?

"As this trial is in Phase 1, there is only limited evidence of the Peanut SLIT-tablet's safety and efficacy. Thus, our team at Power assigned it a score of 1 on their scale."

Answered by AI

Are individuals who exceed the age of 35 eligible to be part of this research study?

"Patients aged 4 to 65 are allowed entry into this trial, in addition to the 85 studies for minors and 156 trials catering to seniors."

Answered by AI

Could I potentially qualify for this trial?

"This research initiative is looking to recruit 90 individuals aged 4-65 suffering from a documented, IgE-mediated peanut allergy. Participants must meet the following criteria: Inclusionary requirements for both parts of this trial (unless otherwise specified), Part 1: Males or females ages 18 through 65 on enrollment date, Part 2: Male or female between 4 and 65 years old upon matriculation into the study, Clinical history of an Immunoglobulin E mediated reaction towards food containing peanuts, Serum specific Immunoglobulin E ≥ 0.7 kUA/L at screening taken in a central laboratory setting, Skin prick test results with 5"

Answered by AI

Is there a cap to the number of enrollees in this clinical research program?

"This medical study necessitates the participation of 90 individuals who satisfy the requirements. These recruits can be sourced from Family Allergy Asthma Research Institute in Louisville, Kentucky or Allergy & Asthma Clinical Research in Walnut Creek, California and other nearby locations."

Answered by AI
~22 spots leftby Oct 2024