Peanut HypersensitivityPhase 1/2NCT01084174
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
A Phase 1/2 study testing Peanut powder and Peanut extract in people with Peanut Hypersensitivity and Food Hypersensitivity, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Peanut Hypersensitivity, Food Hypersensitivity, Immediate Hypersensitivity
- What is being tested?
- Peanut powder and Peanut extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2013
- Phase
- Phase 1/2
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are ages 6 to 21 years of either sex, any race, and any ethnicity at the time of the initial visit.
- Have a physician diagnosed peanut allergy or a convincing clinical history of peanut allergy (urticaria, upper or lower respiratory symptoms, GI disturbances, rash or oral symptoms).
- Have a skin prick test positive to peanut (diameter of wheal 3 mm ≥ negative control) and detectable serum peanut-specific IgE level (UniCAP ≥ 0.35 kU/L).
- Have a positive reaction to a cumulative dose of ≤1,000 mg of peanut powder in the initial qualifying DBPCFC.
- Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994).
- Have self-injectable epinephrine (i.e. EpiPen® or EpiPen Jr.®) available at all times.
- Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable.
Who cannot join
- Have a history of severe anaphylaxis to peanut with hypoxia (cyanosis or peripheral capillary oxygen saturation (SpO2) ≤92% at any stage), hypotension or neurological compromise (confusion, collapse, loss of consciousness or incontinence).
- Tolerates more than 1,000 mg of peanut powder at the initial qualifying DBPCFC.
- Have a viral upper respiratory infection (URI) or gastroenteritis within 7 days of OFC (OFC will need to be rescheduled).
- Currently participating in a study using an investigational new drug.
- Participation in any interventional study for the treatment of food allergy in the past 12 months.
- Pregnancy or lactation
Show all 25Show fewer
- Allergy to placebo ingredients (Glycerin or oat flour) OR reacts to any dose of placebo during the qualifying OFC.
- Currently in a buildup phase of any allergy immunotherapy.
- Poor control of atopic dermatitis.
- Have pulmonary function tests with forced expiratory volume 1 (FEV1) value <80% predicted or any clinical features of greater than moderate persistent asthma and greater than high daily doses of inhaled corticosteroids (>500µg/day fluticasone or equivalent).
- Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or IV or oral corticosteroid burst) in the following manners:
- o History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or burst oral steroid course in the past 6 months or > 1 burst oral steroid course in the past year.
- Asthma requiring
- ≥1 hospitalization in the past year for asthma or
- >1 ER visit in the past 6 months for asthma
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immuno-modulatory therapy (not including corticosteroids) or biologic therapy within the past year.
- Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB), calcium channel blockers or tricyclic antidepressant therapy.
- Inability to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or OFC's.
- History of alcohol or drug abuse.
- Active eosinophilic gastrointestinal disease in the past two years.
- Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders) which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions.
- Any previous intubation due to allergies or asthma.
- Severe reaction at initial DBPCFC, defined as:
- Life-threatening anaphylaxis
- Requiring overnight hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University
Baltimore, Maryland, 21287-3923
About this study
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Read the detailed description
To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of >0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.
Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.
Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.
- Being tested
- Peanut powder, Peanut extract, Placebo extract, Placebo powder
- Keywords
- Peanut Allergy
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut powderDrug
Delivered orally
Peanut extractDrug
Delivered sublingually
Placebo extractDrug
Delivered sublingually
Placebo powderDrug
Delivered orally
| Study group | Role | What they receive |
|---|---|---|
| Active SLIT/Placebo OIT | Experimental | These subjects will receive peanut powder given orally and placebo extract given sublingually. Receives: Drug: Peanut powder; Drug: Placebo extract |
| Active OIT/Placebo SLIT | Experimental | These subjects will receive peanut extract given sublingually and placebo powder given orally. Receives: Drug: Peanut extract; Drug: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Induced Peanut Desensitization at 12 Months
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
Measured: 12 months
Secondary outcomes (6)
Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
Serum immunoglobulin G4 (IgG4) levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at the end of dose build-up (up to 16 weeks)
Measured: Baseline and end of dose build-up (up to 16 weeks)
Between Arm Change in IgG4 From Baseline to 6 Months
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 6 months
Measured: Baseline and 6 months
Between Arm Change in IgG4 From Baseline to 12 Months
IgG4 levels are measured in milligrams of Antibody per liter (mga/L) and were collected at baseline and at 12 months
Measured: Baseline and 12 months
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
Measured: Baseline to end of dose build-up (up to 16 weeks)
Between Arm Change in IgE From Baseline to 6 Months
Serum immunoglobulin E (IgE) levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 6 months
Measured: Baseline and 6 months
Between Arm Change in IgE From Baseline to 12 Months
IgE levels are measured in kilo units of Antibody per liter (kUa/L) and were collected at baseline and at 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionJan 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Peanut HypersensitivityStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084174
- Sponsor's protocol ID
- NA_00032256
- Status last verified
- Feb 2017
- First submitted
- 8 Mar 2010
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Narisety SD, Frischmeyer-Guerrerio PA, Keet CA, Gorelik M, Schroeder J, Hamilton RG, Wood RA. A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy. J Allergy Clin Immunol. 2015 May;135(5):1275-82.e1-6. doi: 10.1016/j.jaci.2014.11.005. Epub 2014 Dec 18.
PubMed 25528358
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
- ClinicalTrials.gov ID
- NCT01084174
- Acronym / sponsor ID
- NA_00032256
- Keywords
- Peanut Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Detailed description
To effectively address the Primary Objectives of this pilot study, 30 subjects aged 6-21 years with: (1) a convincing clinical history of peanut allergy (PA), (2) a serum immunoglobulin E (IgE) specific to peanut of >0.35 kilo units per liter (kU/L) and a skin prick test (SPT) wheal >3 mm, will be enrolled. Subjects will be recruited from the Johns Hopkins Pediatric Allergy Clinic.
Participants will undergo an initial screening visit that will include a medical history, physical exam, skin testing, and phlebotomy. Informed consent and assent will be obtained. At the next two visits, 20 participants will complete a double-blind placebo-controlled food challenge (DBPCFC). Eligible subjects will be randomized in a 1:1 ratio into two groups. One group will receive active SLIT with placebo OIT and the other group will begin active OIT with placebo SLIT dose escalation. Over the next 16 weeks of the study, subjects will undergo SLIT and OIT dose increases. A maintenance dose will then be taken at home daily for 12 months. A DBPCFC will be completed after 6 months and 12 months of home dosing. Those patients who pass the DBPCFC will be taken off SLIT and OIT for 4 weeks. A final challenge will be administered at the end of this period.
Ten additional peanut-allergic subjects age 6-21 years will be enrolled and followed as longitudinal controls for the mechanistic studies. These subjects will follow a modified schedule compared to those subjects receiving study treatment and will be evaluated by phlebotomy, end point titration prick skin testing, and saliva collection. These patients will continue strict avoidance of peanut unless otherwise advised by their personal physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active SLIT/Placebo OIT | Experimental | Drug: Peanut powder, Drug: Placebo extractThese subjects will receive peanut powder given orally and placebo extract given sublingually. |
| Active OIT/Placebo SLIT | Experimental | Drug: Peanut extract, Drug: Placebo powderThese subjects will receive peanut extract given sublingually and placebo powder given orally. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Are ages 6 to 21 years of either sex, any race, and any ethnicity at the time of the initial visit.
- Have a physician diagnosed peanut allergy or a convincing clinical history of peanut allergy (urticaria, upper or lower respiratory symptoms, GI disturbances, rash or oral symptoms).
- Have a skin prick test positive to peanut (diameter of wheal 3 mm ≥ negative control) and detectable serum peanut-specific IgE level (UniCAP ≥ 0.35 kU/L).
- Have a positive reaction to a cumulative dose of ≤1,000 mg of peanut powder in the initial qualifying DBPCFC.
- Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
Key exclusion criteria (25 listed)
- Have a history of severe anaphylaxis to peanut with hypoxia (cyanosis or peripheral capillary oxygen saturation (SpO2) ≤92% at any stage), hypotension or neurological compromise (confusion, collapse, loss of consciousness or incontinence).
- Tolerates more than 1,000 mg of peanut powder at the initial qualifying DBPCFC.
- Have a viral upper respiratory infection (URI) or gastroenteritis within 7 days of OFC (OFC will need to be rescheduled).
- Currently participating in a study using an investigational new drug.
- Participation in any interventional study for the treatment of food allergy in the past 12 months.
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 powderDelivered orally | Drug | Active SLIT/Placebo OIT |
| Peanut extractDelivered sublingually | Drug | Active OIT/Placebo SLIT |
| Placebo extractDelivered sublingually | Drug | Active SLIT/Placebo OIT |
| Placebo powderDelivered orally | Drug | Active OIT/Placebo SLIT |
Primary outcome
Number of Participants With Induced Peanut Desensitization at 12 Months
Time frame: 12 months
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
6 secondary outcomes
Between Arm Change in IgG4 From Baseline to End of Dose Build-up (up to 16 Weeks)
Time frame: Baseline and end of dose build-up (up to 16 weeks)
Between Arm Change in IgG4 From Baseline to 6 Months
Time frame: Baseline and 6 months
Between Arm Change in IgG4 From Baseline to 12 Months
Time frame: Baseline and 12 months
Between Arm Change in IgE From Baseline to End of Dose Build-up (up to 16 Weeks)
Time frame: Baseline to end of dose build-up (up to 16 weeks)
Between Arm Change in IgE From Baseline to 6 Months
Time frame: Baseline and 6 months
Between Arm Change in IgE From Baseline to 12 Months
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25528358Narisety SD, Frischmeyer-Guerrerio PA, Keet CA, Gorelik M, Schroeder J, Hamilton RG, Wood RA. A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy. J Allergy Clin Immunol. 2015 May;135(5):1275-82.e1-6. doi: 10.1016/j.jaci.2014.11.005. Epub 2014 Dec 18.
- Individual participant dataSharing planned: No
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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 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peanut powder and Peanut extract in people with Peanut Hypersensitivity and Food Hypersensitivity, 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 8 inclusion and 25 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 7 Apr 2017. 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 combined 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.
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 7 Apr 2017). 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 Induced Peanut Desensitization at 12 Months (time frame: 12 months). 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 NCT01084174, which also lists 1 linked publication.
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 7 Apr 2017.