Peanut HypersensitivityPhase 2IMPACTNCT01867671
Peanut Oral Immunotherapy in Children
A Phase 2 study testing Peanut Oral Immunotherapy - Liquid Extract and Peanut Oral Immunotherapy - Peanut Flour in people with Peanut Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Peanut Hypersensitivity
- What is being tested?
- Peanut Oral Immunotherapy - Liquid Extract and Peanut Oral Immunotherapy - Peanut Flour
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Aug 2013to 21 Dec 2018
- 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 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
- Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
- Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
- A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
- Written informed consent from parent/guardian.
Who cannot join
- History of severe anaphylaxis with hypotension to peanut;
- Documented clinical history of allergy to oat;
- Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
- Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
- Active eosinophilic gastrointestinal disease in the past 2 years;
- Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
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- Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
- Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
- Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
- Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
- Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
- Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
- Use of any investigational drug in 90 days prior to visit -1;
- Plan to use any investigational drug during the study period;
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
UNC Chapel-Hill
Chapel Hill, North Carolina, 27599
University of Arkansas for Medical Sciences: Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Mount Sinai School of Medicine
New York, New York, 10029
Stanford University School of Medicine
Stanford, California, 94040
About this study
Official title: Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Read the detailed description
An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:
- Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
- Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
- Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
- Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).
- Conditions
- Peanut Hypersensitivity
- Being tested
- Peanut Oral Immunotherapy - Liquid Extract, Placebo for Peanut Oral Immunotherapy - Liquid Extract form, Peanut Oral Immunotherapy - Peanut Flour, Placebo for Peanut Oral Immunotherapy - Peanut Flour
- Keywords
- Allergy, Peanut, Peanut allergy, Hypersensitivity, Immunotherapy, Desensitization, Immunologic
- 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.
Peanut Oral Immunotherapy - Liquid ExtractBiological
Used during initial dose escalation for doses 0.1 to 0.8 mg.
Placebo for Peanut Oral Immunotherapy - Liquid Extract formBiological
Similar in appearance, texture, and taste to peanut liquid extract.
Peanut Oral Immunotherapy - Peanut FlourBiological
This will be used for the remainder of dose escalation, build-up, and maintenance.
Placebo for Peanut Oral Immunotherapy - Peanut FlourBiological
Similar in appearance, texture, and taste to peanut flour.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Oral Immune Therapy (OIT) | Experimental | Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks. Receives: Biological: Peanut Oral Immunotherapy - Liquid Extract; Biological: Peanut Oral Immunotherapy - Peanut Flour |
| Peanut Placebo | Placebo comparator | Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material. Receives: Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form; Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.*
*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
Measured: Week 134
Secondary outcomes (4)
Percentage of Tolerant Participants at Week 160
Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).
Measured: Week 160
Count of Participants With Transient Desensitization
Definition of transient desensitization: A participant who passed the blinded (masked) oral food challenge (OFC) to 10 grams peanut flour (=5 grams peanut protein) at week 134 and failed the week 160 in the Peanut oral immunotherapy (OIT) group.
Measured: Week 134, Week 160
Highest Tolerated Cumulative Dose
The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome.
Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero.
Measured: Week 160
Percentage of Participants That Withdrew From the Study
Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).
Measured: Initial Dose Escalation through Week 160 (Tolerance Assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start13 Aug 2013
- Primary completion2 Jul 2018
- Study completion21 Dec 2018
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Wesley Burks, MD, Study chair, UNC Chapel-HillStacie M. Jones, MD, Study chair, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867671
- Sponsor's protocol ID
- DAIT ITN050AD
- Acronym
- IMPACT
- Status last verified
- Feb 2020
- First submitted
- 23 May 2013
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
- ClinicalTrials.gov ID
- NCT01867671
- Acronym / sponsor ID
- IMPACT / DAIT ITN050AD
- Conditions
- Peanut Hypersensitivity
- Keywords
- Allergy, Peanut, Peanut allergy, Hypersensitivity, Immunotherapy, Desensitization, Immunologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Detailed description
An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:
- Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
- Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
- Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
- Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Oral Immune Therapy (OIT) | Experimental | Biological: Peanut Oral Immunotherapy - Liquid Extract, Biological: Peanut Oral Immunotherapy - Peanut FlourPeanut OIT for 134 weeks followed by peanut avoidance for 26 weeks. |
| Peanut Placebo | Placebo comparator | Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form, Biological: Placebo for Peanut Oral Immunotherapy - Peanut FlourPeanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
- Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
- Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
- A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
- Written informed consent from parent/guardian.
Key exclusion criteria (16 listed)
- History of severe anaphylaxis with hypotension to peanut;
- Documented clinical history of allergy to oat;
- Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
- Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
- Active eosinophilic gastrointestinal disease in the past 2 years;
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 Oral Immunotherapy - Liquid ExtractUsed during initial dose escalation for doses 0.1 to 0.8 mg. | Biological | Peanut Oral Immune Therapy (OIT) |
| Placebo for Peanut Oral Immunotherapy - Liquid Extract formSimilar in appearance, texture, and taste to peanut liquid extract. | Biological | Peanut Placebo |
| Peanut Oral Immunotherapy - Peanut FlourThis will be used for the remainder of dose escalation, build-up, and maintenance. | Biological | Peanut Oral Immune Therapy (OIT) |
| Placebo for Peanut Oral Immunotherapy - Peanut FlourSimilar in appearance, texture, and taste to peanut flour. | Biological | Peanut Placebo |
Primary outcome
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
Time frame: Week 134
Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.* *Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.
4 secondary outcomes
Percentage of Tolerant Participants at Week 160
Time frame: Week 160
Count of Participants With Transient Desensitization
Time frame: Week 134, Week 160
Highest Tolerated Cumulative Dose
Time frame: Week 160
Percentage of Participants That Withdrew From the Study
Time frame: Initial Dose Escalation through Week 160 (Tolerance Assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT) websiteLink provided by the sponsor.
- Immune Tolerance Network websiteLink provided by the sponsor.
- ITN IMPACT Study websiteLink provided by the sponsor.
Related trials for Peanut Hypersensitivity
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Study of Oral Food Challenge Biomarkers (SAFER)
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EPAP, Interviewstudy
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Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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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.
Wesley Burks, MD study chair
UNC Chapel-Hill
Stacie M. Jones, MD study chair
University of Arkansas
5 sites 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 Oral Immunotherapy - Liquid Extract and Peanut Oral Immunotherapy - Peanut Flour in people with Peanut Hypersensitivity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites 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 5 inclusion and 16 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 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 22 Jan 2020). 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?
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) (time frame: Week 134). 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 16 Mar 2020.