Peanut AllergyPhase 2NCT04761835
STEP-IT-UP - Peanut Allergy Study for Infants
A Phase 2 study testing Peanut powder or peanut butter in people with Peanut Allergy and Food Allergy, run by Johns Hopkins University.
Trial summary
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to… Read more about this study
- Who is it for?
- Ages 4 to 14 months
- Conditions the study is for
- Peanut Allergy, Food Allergy
- What is being tested?
- Peanut powder or peanut butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 4-14 months suspected to be peanut allergic
Who cannot join
- Significant medical problems
About this study
Official title: Subthreshold Peanut in Infants - Understanding Plasticity
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
- Conditions
- Peanut Allergy, Food Allergy
- Being tested
- Peanut powder or peanut butter
- Keywords
- infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut powder or peanut butterBiological
Commercially available peanut powder or peanut butter.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Peanut | Active comparator | Participants in this group will be asked to continue peanut in their diet for 1 year at a dose determined from the double blind placebo controlled food challenge at baseline. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine their current peanut threshold. The current peanut threshold will be used to determine which participants will go into clinical care and which will get sustained unresponsiveness food challenges to peanut. Receives: Biological: Peanut powder or peanut butter |
| Strict avoidance | No intervention | Participants in this group will be asked to strictly avoid any peanut in their diet for 1 year. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine whether they will transition to daily dietary peanut or continue with clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral food challenge threshold to peanut at week 52
compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months between subjects randomized to dietary peanut introduction and those randomized to avoidance.
Measured: 52 weeks
Secondary outcomes (7)
1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance
Compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months of dietary peanut between subjects randomized to dietary peanut introduction first and those randomized to avoidance for 52 weeks and subsequent dietary peanut after week 52.
Measured: 104 weeks
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
Comparison of OFC threshold (in milligrams) at 1 month of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Measured: 56 weeks
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
Comparison of OFC threshold (in milligrams) at 2 months of avoidance (sustained unresponsiveness) after 12 months of dietary peanut between those initially randomized to peanut and those randomized to delayed introduction.
Measured: 60 weeks
Safety with dietary introduction of peanut or avoidance
Number of participants who have severe (grade 3) anaphylaxis secondary to any DBPCFC or ingestion of the measured dose of peanut.
Measured: 52 weeks
Rate of discontinuation of dietary peanut
Number of participants randomized to dietary peanut who discontinue peanut.
Measured: 104 weeks
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
Eczema severity as assessed by the SCORAD. The SCORAD has a component for patient measured outcomes and also provider assessment of eczema involvement. It has an overall score range of 0-100, where higher scores signify more severe eczema.
Measured: 104 weeks
Peanut skin prick test wheal size
Average wheal size (millimeters) of peanut skin prick test for participants in each group.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Why it stopped: Withdrawn in IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open label, randomized trial (1:1) to either dietary peanut intake or strict avoidance prior to a double blind placebo controlled food challenge 52 weeks later.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Corinne Keet, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761835
- Sponsor's protocol ID
- IRB00279285
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant level data will be shared. Only aggregate data from the study will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Peanut in Infants - Understanding Plasticity
- ClinicalTrials.gov ID
- NCT04761835
- Acronym / sponsor ID
- IRB00279285
- Conditions
- Peanut Allergy, Food Allergy
- Keywords
- infant food allergy, treatment study, peanut allergy treatment, increase threshold of peanut intake for peanut allergic children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn in IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter randomized (1:1) trial of strict avoidance versus sub-threshold dietary introduction of peanut in peanut allergic infants 4-14 months of age who react at a minimum cumulative dose of at least 430 mg of peanut protein at initial oral food challenge (OFC) for 12 months, followed by cross-over to sub-threshold dietary introduction of peanut in those randomized initially to avoidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized trial (1:1) to either dietary peanut intake or strict avoidance prior to a double blind placebo controlled food challenge 52 weeks later.
| Arm | Type | Receives |
|---|---|---|
| Dietary Peanut | Active comparator | Biological: Peanut powder or peanut butterParticipants in this group will be asked to continue peanut in their diet for 1 year at a dose determined from the double blind placebo controlled food challenge at baseline. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine their current peanut threshold. The current peanut threshold will be used to determine which participants will go into clinical care and which will get sustained unresponsiveness food challenges to peanut. |
| Strict avoidance | No intervention | –Participants in this group will be asked to strictly avoid any peanut in their diet for 1 year. After the 1 year period, participants will be given another double blind placebo controlled food challenge which will be used to determine whether they will transition to daily dietary peanut or continue with clinical care. |
Who may qualify
- Ages
- 4 to 14 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 4-14 months suspected to be peanut allergic
Key exclusion criteria (1 listed)
- Significant medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut powder or peanut butterCommercially available peanut powder or peanut butter. | Biological | Dietary Peanut |
Primary outcome
Oral food challenge threshold to peanut at week 52
Time frame: 52 weeks
compare the oral food challenge threshold (in milligrams) to peanut during a double-blind placebo-controlled food challenge (DBPCFC) after 12 months between subjects randomized to dietary peanut introduction and those randomized to avoidance.
7 secondary outcomes
1. Oral food challenge threshold to peanut at week 52 for those initially randomized to dietary peanut compared to the oral food challenge threshold at week 104 for those initially randomized to strict avoidance
Time frame: 104 weeks
Oral food challenge threshold at 1 month avoidance after 12 months in each treatment group
Time frame: 56 weeks
Oral food challenge threshold at 2 months avoidance after 12 months in each treatment group
Time frame: 60 weeks
Safety with dietary introduction of peanut or avoidance
Time frame: 52 weeks
Rate of discontinuation of dietary peanut
Time frame: 104 weeks
Severity of eczema as assessed by the Scoring Atopic Dermatitis (SCORAD) score
Time frame: 104 weeks
Peanut skin prick test wheal size
Time frame: 104 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: No. No individual participant level data will be shared. Only aggregate data from the study will be shared.
Related trials for Peanut Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Keet principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peanut powder or peanut butter in people with Peanut Allergy and Food Allergy, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral food challenge threshold to peanut at week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.