Peanut AllergyPhase 1/2NCT01897077
The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
A Phase 1/2 study testing Peanut Dissolving Film in people with Peanut Allergy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut Dissolving Film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to 3 Feb 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 50 years
- Provide signed informed consent
- Using appropriate birth control if subject is female and of child bearing age
- Are available for the study duration
- Healthy Volunteers Only
- Regularly consume a meal sized portion (5 grams) of peanut at least twice per month during the proceeding 6 months
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- Peanut Allergic Subjects Only
- Have a history of symptomatic reactivity to peanut
- Have a positive skin prick test
- Have a positive oral food challenge to peanut at a cumulative dose of less than 1 grams of peanut protein
- Have self-injectable epinephrine available at home
Who cannot join
- Have a history of severe anaphylaxis to peanut, defined as hypoxia, hypotension or neurological compromise as a result of ingestion of peanut.
- Have a history of intubation related to asthma
- Are pregnant or lactating
- Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of Oral food challenge
- Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
- Are currently taking greater than medium dose inhaled corticosteroid (>500 mcg/day fluticasone or fluticasone equivalent)
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- Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
- Have used systemic corticosteroids within 4 weeks prior to baseline visit
- Are receiving omalizumab, beta-blocker, Angiotensin Converting Enzyme (ACE) inhibitor or tricyclic antidepressant therapy. Subjects need to be off omalizumab for 6 months.
- Have history of oral cancer.
- Use oral tobacco (i.e., chew tobacco)
- Have a chronic disease (other than asthma, atopic dermatitis or rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Have participated in any interventional study for treatment of a food allergy in the past 12 months
- Have a history of eosinophilic esophagitis
- Have a severe reaction at initial double blind placebo-controlled food challenge, defined as either:
- Life-threatening anaphylaxis, or
- Reaction requiring hospitalization
- Healthy Volunteers Only
- History of any allergy to peanut
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mount Sinai School of Medicine
New York, New York, 10029
About this study
The purpose of this study is to determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.
Read the detailed description
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.
- Conditions
- Peanut Allergy
- Being tested
- Peanut Dissolving Film
- Keywords
- Food Allergy, Peanut, Sublingual Immunotherapy
- 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 Dissolving FilmDrug
| Study group | Role | What they receive |
|---|---|---|
| Peanut Allergic | Experimental | Only one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. Receives: Drug: Peanut Dissolving Film |
| Healthy Volunteers | Active comparator | Healthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. Receives: Drug: Peanut Dissolving Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons
No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.
Measured: 18 months
Secondary outcomes (5)
The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study
For peanut allergic subjects only
Measured: 18 months
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
Measured: 18 months
The Rate of Medication Use With Therapy
For peanut allergic subjects only.
Measured: 18 months
Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy
Only in peanut allergic subjects
Measured: 18 months
Number of Participants With Serious Adverse Events With Dosing
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startNov 2012
- Primary completion3 Feb 2013
- Study completion3 Feb 2013
Why it stopped: Study product manufacturing suspended due to manufacturing problems, before initiation of study intervention.
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- Robert Wood, MD, Principal investigator, Johns Hopkins UniversityCorinne Keet, MD, MS, Principal investigator, Johns Hopkins UniversityHugh Sampson, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897077
- Sponsor's protocol ID
- NA_00042409
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2013
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of a Peanut Immunotherapy Dissolving Film for Peanut Allergy
- ClinicalTrials.gov ID
- NCT01897077
- Acronym / sponsor ID
- NA_00042409
- Conditions
- Peanut Allergy
- Keywords
- Food Allergy, Peanut, Sublingual Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study product manufacturing suspended due to manufacturing problems, before initiation of study intervention.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Nov 2012 (actual)
- Primary completion
- 3 Feb 2013 (actual)
- Study completion
- 3 Feb 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Posted 3 Jul 2018
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 determine if a new method of administration of peanut sublingual immunotherapy, a dissolving peanut film, is effective.
Detailed description
Peanut allergy is a common problem with no current treatment. Recent studies have shown some success with oral or sublingual immunotherapy for the treatment of food allergy. Oral treatment, which requires very high doses, is associated with a small but appreciable risk of systemic reactions. Sublingual immunotherapy, which utilizes much smaller doses, is safer but constraints inherent in the available methods of sublingual administration have limited the utility of this method. Typically sublingual immunotherapy for food allergy has used either fresh foods or a simple liquid extract. These methods are not optimized for practicality or dwell duration in the mouth, and, thus far, dosing has been limited by the ability to make concentrated extracts and by the volume of extract that can be applied to the sublingual space. This study is being conducted to determine if a dissolving peanut extract film, will improve efficacy for immunotherapy for peanut allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Allergic | Experimental | Drug: Peanut Dissolving FilmOnly one intervention will be given. Peanut allergic study subjects, will receive gradually increasing doses of the dissolving peanut film. |
| Healthy Volunteers | Active comparator | Drug: Peanut Dissolving FilmHealthy volunteers will receive active peanut dissolving films in an expedited manner in order to determine safety dissolving films. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18 to 50 years
- Provide signed informed consent
- Using appropriate birth control if subject is female and of child bearing age
- Are available for the study duration
- Healthy Volunteers Only
Key exclusion criteria (19 listed)
- Have a history of severe anaphylaxis to peanut, defined as hypoxia, hypotension or neurological compromise as a result of ingestion of peanut.
- Have a history of intubation related to asthma
- Are pregnant or lactating
- Have a viral Upper Respiratory Infection (URI) or gastroenteritis within 7 days of Oral food challenge
- Have pulmonary function tests <80% of predicted (FEV1) or clinical history consistent with more than moderate persistent asthma
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 Dissolving Film | Drug | Healthy Volunteers, Peanut Allergic |
Primary outcome
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons
Time frame: 18 months
No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.
5 secondary outcomes
The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study
Time frame: 18 months
Number of Participants With Serious and Non-serious Adverse Effects With Therapy
Time frame: 18 months
The Rate of Medication Use With Therapy
Time frame: 18 months
Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy
Time frame: 18 months
Number of Participants With Serious Adverse Events With Dosing
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Corinne Keet, MD, MS principal investigator
Johns Hopkins University
Hugh Sampson, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites 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 Dissolving Film in people with Peanut Allergy, run by Johns Hopkins University at 2 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 11 inclusion and 19 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: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 3 Jul 2018). 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?
The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons (time frame: 18 months). 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 3 Jul 2018.