Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT04511494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SmaChO
Brief Summary:
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to:
1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
2. Control group with peanut allergic children who do not undergo OIT.
3. In addition, a group of healthy children without allergic diseases will be included in the study.
The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance.
Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
1. Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
2. Control group with peanut allergic children who do not undergo OIT.
3. In addition, a group of healthy children without allergic diseases will be included in the study.
The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance.
Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
Detailed Description:
Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (\<4 years).
Intervention: Peanut OIT in children aged 1-3 years with peanut allergy (clinical symptoms at peanut challenge and IgE \>0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched non-allergic children:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 285 mg peanut protein. Three years' treatment. (n=50 patients)
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut (peanut avoidance group). Peanut challenges are performed one and three years after inclusion. (n=25 patients)
Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group. (n=30 patients)
Group 4; Children not reacting at the baseline peanut challenge (n=9 patients)
Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-3 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2.
Children without allergies, healthy controls (group 3), will be included from Västerås Hospital.
If children are included in the study but they do not not react at the baseline peanutchallenge, they will not have any intervention (are not eligible to randomisation) and will have a follow-up after 1+3 years (without peanut challenges), group 4.
Outcomes: The primary outcome is defined as sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at an open oral peanut challenge after 3 years of OIT followed by 4-6 weeks of avoidance (group 1 and 2).
Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).
Intervention: Peanut OIT in children aged 1-3 years with peanut allergy (clinical symptoms at peanut challenge and IgE \>0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched non-allergic children:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 285 mg peanut protein. Three years' treatment. (n=50 patients)
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut (peanut avoidance group). Peanut challenges are performed one and three years after inclusion. (n=25 patients)
Group 3; Healthy, non-allergic, age-matched children. No challenges are performed in this group. (n=30 patients)
Group 4; Children not reacting at the baseline peanut challenge (n=9 patients)
Inclusion of study subjects: A review of samples sent to the Karolinska University Laboratory for IgE-ab responses to peanut/Ara h 2 for children in the Stockholm area aged 1-3 years is used for identification of potential participants to whom a letter is sent with information about the study. The families are randomized 2:1 to OIT or control group, group 1 or group 2.
Children without allergies, healthy controls (group 3), will be included from Västerås Hospital.
If children are included in the study but they do not not react at the baseline peanutchallenge, they will not have any intervention (are not eligible to randomisation) and will have a follow-up after 1+3 years (without peanut challenges), group 4.
Outcomes: The primary outcome is defined as sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at an open oral peanut challenge after 3 years of OIT followed by 4-6 weeks of avoidance (group 1 and 2).
Secondary outcomes are adverse events among peanut allergic children with/without OIT treatment (group 1 and 2), and changes in quality of life parameters and immunological markers (group, 1, 2, 3).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: