Treatment EfficacyPhase 2NCT03345160
Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
A Phase 2 study testing Peanut Flour in people with Treatment Efficacy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Treatment Efficacy
- What is being tested?
- Peanut Flour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2018to 7 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- Subjects who were randomized to the placebo arm of protocol NA_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children."
- Parent guardian must be able to understand and provide informed consent
- Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut protein during the End-of-Treatment food challenge from Protocol NA_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children"
Who cannot join
- Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol
- History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension, neurological compromise, confusion, cardiovascular collapse, or loss of consciousness
- Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis) requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the investigator to have potential impact on study outcomes or safety.
- Severe or poorly controlled atopic dermatitis per investigator's discretion
- Past or current history of eosinophilic gastrointestinal disease
Show all 12Show fewer
- Diagnosis of asthma that meets any of the following criteria:
- Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest guidelines)
- History of 2 or more systemic corticosteroid courses or 1 systemic course within the 3 previous months prior to visit 1 for treating wheezing
- Prior intubation/mechanical ventilation for asthma
- Currently receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Current participation in another clinical trial or participation in another clinical trial in the last 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. As part this protocol, all participants who received placebo treatment were promised the opportunity to receive open label treatment at the conclusion of the double-blind phase and initial follow-up. At the time of submitting that protocol, the investigator did not specify any detailed protocol for the open label crossover treatment, as this is an evolving field, but the investigator is now ready to offer this open label treatment as promised.
Read the detailed description
This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo arm of the IMPACT study.
Once subjects have completed participation in the IMPACT study, subjects will be offered the option of participating in this open label, peanut oral immunotherapy study.
After the informed consent has been signed, subjects will undergo an initial dose escalation to peanut protein to establish the starting dose for the build-up phase. The starting dose of peanut protein for the build-up phase will be the highest tolerated dose during the initial dose escalation. The subject will return to the study site and the first starting dose of peanut protein will be given under observation. Subjects will be sent home with doses of peanut protein to administer at home.
Subject will return every 2 weeks for dose adjustments. Once subjects have tolerated a dose under observation, subjects will then continue dosing at home with OIT and return to the research unit every 2 weeks for a 1-step dose escalation to a maximum daily dose of 1000 mg. Participants who do not reach the 1000mg dose by 40-weeks of build-up phase may enter the maintenance phase at their highest tolerated dose.
When subjects reach their maximum tolerated dose of either 1000 mg per day, or the maximum tolerated dose during the 40 weeks of the build-up phase, subjects will enter the maintenance phase. Subjects will continue daily dosing of peanut protein at the maximum tolerated dose during the 12-week maintenance phase.
At the end of the maintenance phase, subjects will undergo an open peanut oral food challenge to a maximum of 4000 mg of peanut protein to determine individualized guidelines for the introduction of peanut into the subject's diet based on the outcome of the open peanut challenge The primary objective of this protocol is to provide open label peanut oral immunotherapy (OIT) for those subjects who received placebo treatment in the IMPACT Study .
Secondary objectives will include:
- Efficacy of the treatment, as defined by an end of treatment oral peanut challenge.
Safety, as measured by the incidence of adverse events and the proportion of subjects who discontinue treatment due to adverse events
- Conditions
- Treatment Efficacy
- Being tested
- Peanut Flour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut FlourDrug
Also called Peanut Oral Immunotherapy
open label oral immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Peanut Flour: Open label peanut OIT | Experimental | This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study Receives: Drug: Peanut Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events (AEs)
Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.
Measured: up to 52 weeks
Secondary outcomes (1)
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge
This measure assessed the amount of peanut protein [in milligrams (mg)] tolerated by each participant at the end-of-treatment peanut challenge.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 Apr 2018
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Treatment EfficacyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wood, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345160
- Sponsor's protocol ID
- IRB00150453
- Status last verified
- Oct 2021
- First submitted
- 6 Nov 2017
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Publications
Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jun;178(2):280-292. doi: 10.1111/imm.70098. Epub 2026 Jan 30.
PubMed 41615410Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.
PubMed 35065784
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
- ClinicalTrials.gov ID
- NCT03345160
- Acronym / sponsor ID
- IRB00150453
- Conditions
- Treatment Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. As part this protocol, all participants who received placebo treatment were promised the opportunity to receive open label treatment at the conclusion of the double-blind phase and initial follow-up. At the time of submitting that protocol, the investigator did not specify any detailed protocol for the open label crossover treatment, as this is an evolving field, but the investigator is now ready to offer this open label treatment as promised.
Detailed description
This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo arm of the IMPACT study.
Once subjects have completed participation in the IMPACT study, subjects will be offered the option of participating in this open label, peanut oral immunotherapy study.
After the informed consent has been signed, subjects will undergo an initial dose escalation to peanut protein to establish the starting dose for the build-up phase. The starting dose of peanut protein for the build-up phase will be the highest tolerated dose during the initial dose escalation. The subject will return to the study site and the first starting dose of peanut protein will be given under observation. Subjects will be sent home with doses of peanut protein to administer at home.
Subject will return every 2 weeks for dose adjustments. Once subjects have tolerated a dose under observation, subjects will then continue dosing at home with OIT and return to the research unit every 2 weeks for a 1-step dose escalation to a maximum daily dose of 1000 mg. Participants who do not reach the 1000mg dose by 40-weeks of build-up phase may enter the maintenance phase at their highest tolerated dose.
When subjects reach their maximum tolerated dose of either 1000 mg per day, or the maximum tolerated dose during the 40 weeks of the build-up phase, subjects will enter the maintenance phase. Subjects will continue daily dosing of peanut protein at the maximum tolerated dose during the 12-week maintenance phase.
At the end of the maintenance phase, subjects will undergo an open peanut oral food challenge to a maximum of 4000 mg of peanut protein to determine individualized guidelines for the introduction of peanut into the subject's diet based on the outcome of the open peanut challenge The primary objective of this protocol is to provide open label peanut oral immunotherapy (OIT) for those subjects who received placebo treatment in the IMPACT Study .
Secondary objectives will include:
- Efficacy of the treatment, as defined by an end of treatment oral peanut challenge.
Safety, as measured by the incidence of adverse events and the proportion of subjects who discontinue treatment due to adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label crossover
| Arm | Type | Receives |
|---|---|---|
| Peanut Flour: Open label peanut OIT | Experimental | Drug: Peanut FlourThis is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- Subjects who were randomized to the placebo arm of protocol NA_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children."
- Parent guardian must be able to understand and provide informed consent
- Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut protein during the End-of-Treatment food challenge from Protocol NA_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children"
Key exclusion criteria (12 listed)
- Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol
- History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension, neurological compromise, confusion, cardiovascular collapse, or loss of consciousness
- Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis) requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the investigator to have potential impact on study outcomes or safety.
- Severe or poorly controlled atopic dermatitis per investigator's discretion
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 FlourAlso: Peanut Oral Immunotherapyopen label oral immunotherapy | Drug | Peanut Flour: Open label peanut OIT |
Primary outcome
Number of Participants With Treatment-related Adverse Events (AEs)
Time frame: up to 52 weeks
Number of participants who reported symptoms which were collected as AEs using CTCAE v4.0.
1 secondary outcome
Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge
Time frame: up to 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41615410Kanchan K, Cerosaletti K, Perry JA, DuToit G, Manohar M, Ling H, Paschall JE, Sanda S, Chinthrajah RS, Nepom GT, Nadeau KC, Jones SM, Lack G, Ruczinski I, Mathias RA. Genetic Determinants of Peanut-Specific IgG4 Levels in the Context of Sustained Oral Peanut Exposure in the LEAP Study. Immunology. 2026 Jun;178(2):280-292. doi: 10.1111/imm.70098. Epub 2026 Jan 30.
- Derived from this study: PubMed 35065784Jones SM, Kim EH, Nadeau KC, Nowak-Wegrzyn A, Wood RA, Sampson HA, Scurlock AM, Chinthrajah S, Wang J, Pesek RD, Sindher SB, Kulis M, Johnson J, Spain K, Babineau DC, Chin H, Laurienzo-Panza J, Yan R, Larson D, Qin T, Whitehouse D, Sever ML, Sanda S, Plaut M, Wheatley LM, Burks AW; Immune Tolerance Network. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study. Lancet. 2022 Jan 22;399(10322):359-371. doi: 10.1016/S0140-6736(21)02390-4.
- Individual participant dataSharing planned: No. Data will not be shared
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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.
Robert Wood, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peanut Flour in people with Treatment Efficacy, run by Johns Hopkins University at 1 site in United States.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events (AEs) (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345160, which also lists 2 linked publications.
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 29 Oct 2021.