Peanut HypersensitivityPhase 1BPOITNCT04090203
Boiled Peanut Oral Immunotherapy
A Phase 1 study testing Boiled Peanut Powder in people with Peanut Hypersensitivity, run by Alton Melton at 1 site in United States.
Trial summary
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of… Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Peanut Hypersensitivity
- What is being tested?
- Boiled Peanut Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2019to 20 May 2021
- Phase
- Phase 1
- 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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-16 years
- History of immediate hypersensitivity reaction to peanut
- Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
- SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L
Who cannot join
- History of life threatening peanut anaphylaxis
- Asthma requiring more than medium dose ICS
- Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
- Oat allergy
- Cardiovascular Disease
- Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
Show all 14Show fewer
- Use of steroid medications in the following manners:
- Daily oral steroid dosing for greater than 1 month during the past year
- Burst or steroid course in the past 3 month before inclusion
- Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
- Pregnancy or lactation
- Eosinophilic Gastrointestinal Disease
- History of food protein-induced enterocolitis
- History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
Read the detailed description
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.
- Conditions
- Peanut Hypersensitivity
- Being tested
- Boiled Peanut Powder
- Keywords
- Peanut, Allergy
- Medical subject headings
- Peanut Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boiled Peanut PowderDrug
Also called Immunotherapy
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
| Study group | Role | What they receive |
|---|---|---|
| Boiled Peanut Powder | Experimental | Boiled Peanut Powder Receives: Drug: Boiled Peanut Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start5 Nov 2019
- Primary completion20 May 2021
- Study completion20 May 2021
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.
- Other trials for Peanut HypersensitivityStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective open label phase I
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alton Melton
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Alton Melton, The Cleveland Clinic
- Investigators
- Jaclyn Bjelac, MD, Principal investigator, Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090203
- Sponsor's protocol ID
- BPOIT 18-1294
- Acronym
- BPOIT
- Status last verified
- Sep 2024
- First submitted
- 30 May 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients
- ClinicalTrials.gov ID
- NCT04090203
- Acronym / sponsor ID
- BPOIT / BPOIT 18-1294
- Conditions
- Peanut Hypersensitivity
- Keywords
- Peanut, Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Alton MeltonUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
Detailed description
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective open label phase I
| Arm | Type | Receives |
|---|---|---|
| Boiled Peanut Powder | Experimental | Drug: Boiled Peanut PowderBoiled Peanut Powder |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 1-16 years
- History of immediate hypersensitivity reaction to peanut
- Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
- SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L
Key exclusion criteria (14 listed)
- History of life threatening peanut anaphylaxis
- Asthma requiring more than medium dose ICS
- Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
- Oat allergy
- Cardiovascular Disease
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 |
|---|---|---|
| Boiled Peanut PowderAlso: ImmunotherapyOral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards. | Drug | Boiled Peanut Powder |
Primary outcome
Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
Time frame: 18 weeks
The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peanut Hypersensitivity
Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
Peanut Allergy
RecruitingPhase 1
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Peanut Allergies
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.
Jaclyn Bjelac, MD principal investigator
Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Boiled Peanut Powder in people with Peanut Hypersensitivity, run by Alton Melton 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 14 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 19 Sep 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 Sep 2024). 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?
Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized. (time frame: 18 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 19 Sep 2024.