Peanut HypersensitivityPhase 2FARE/SLITNCT02304991
FARE Peanut SLIT and Early Tolerance Induction
A Phase 2 study testing Liquid Peanut Extract in people with Peanut Hypersensitivity and Food Allergy, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during… Read more about this study
- Who is it for?
- Ages 12 to 48 months
- Conditions the study is for
- Peanut Hypersensitivity, Food Allergy, Food Hypersensitivity
- What is being tested?
- Liquid Peanut Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 31 Dec 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 12 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent from participant's parent/guardian.
- Age 12-48 months of either sex, any race, any ethnicity.
- A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a serum peanut-specific IgE [UniCAP] > 0.35 kUA/L AND a positive skin prick test to peanut (>3 mm than the negative control) OR are sensitized to peanut (based on a serum IgE [UniCAP] to peanut of > 5 kUA/L) AND a positive skin prick test to peanut (> 3 mm than the negative control) and no known history of ingestion of peanut.
- A positive DBPCFC to 1000 mg of peanut at enrollment.
Who cannot join
- History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) < 92% at any stage, hypotension, confusion, collapse or loss of consciousness).
- Participation in any interventional study for the treatment of food allergy in the past 6 months.
- Known oat, wheat, or glycerin allergy.
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2).
- Inability to discontinue antihistamines for skin testing and DBPCFCs.
Show all 9Show fewer
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year.
- Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers.
- Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
Official title: Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months]
Secondary Objectives:
Read more
A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein.
[Time Frame: Baseline, 39 months]
Read the detailed description
Peanut allergy is one of the most common food allergies; most children develop this allergy early in life, do not outgrow it and are at risk for severe and life-ending anaphylactic reactions. There is a critical need for a proactive treatment for peanut allergy and the investigators along with others are developing specific types of immunotherapy that will act as disease-modifying therapies.
This SLIT study is a randomized, blinded, placebo-controlled study. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC performed after 36 months of peanut SLIT (desensitization). A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
Upon enrollment into the study, all subjects will undergo a qualifying entry DBPCFC with peanut protein to confirm the diagnosis of peanut allergy and establish a baseline threshold level. Following a positive DBPCFC, each subject will be randomized 1:1 to receive peanut SLIT therapy versus placebo for a duration of 36 months. DBPCFC will be repeated for both active and placebo subjects at 36 months to assess desensitization and at 39 months to assess tolerance.
Outcome variables of interest include peanut specific IgE, IgG, and IgG4, basophil activation, mast cell responses through skin prick testing, and specific T-cell cytokine responses and T regulatory cell (TReg) activation.
COVID-19 SAFETY MEASURES- Reflected in Protocol V4.0- April 2020
In March of 2020, State and National emergencies were declared over the global pandemic coronavirus COVID-19.
As such, any 36 month Desensitization DBPCFC will be postponed while the safety measures surrounding COVID-19 are in place. Subjects who choose to remain in the study will continue on study drug at the maintenance dose level beyond the originally planned 36 months until such time that the Desensitization DBPCFC is conducted.
Subjects who are scheduled to undergo the 39 month Tolerance DBPCFC while the COVID-19 safety measures are in place will have their DBPCFC cancelled. Additional time off of study drug therapy would potentially increase the risk of allergic reaction during the DBPCFC and would not be acceptable.
For subjects whose Desensitization DBPCFC is postponed, a followup visit to review safety and subject dosing diaries would be conducted. This visit would be conducted remotely by telephone. Additional study drug would be sent direct-to-patient as necessary to continue on maintenance dosing. Lab sample collection and mechanistic studies would be deferred and be completed at the time that the Desensitization DBPCFC is completed. The Tolerance DBPCFC would be completed 3 months after the Desensitization DBPCFC is completed.
For subjects whose Tolerance DBPCFC is canceled, an exit visit would be conducted to review safety. The subject would be unblinded to treatment allocation and end of study instructions would be reviewed with the subject.
As the situation is changing daily, we are unable to provide a time frame for extension. We hope to limit the number of subjects who will need to utilize this option and preserve the endpoint data parameters. Previous SLIT studies have not shown any additional risk with peanut SLIT dosing beyond 3 years up to a total of 5 years of dosing.
- Being tested
- Liquid Peanut Extract, Placebo Glycerin SLIT
- Keywords
- Peanut, Food Allergy
- 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.
Liquid Peanut ExtractDrug
Also called SLIT
5000mcg/ml peanut protein
Placebo Glycerin SLITDrug
Also called SLIT
pure glycerinated saline solution with caramel coloring to match color
| Study group | Role | What they receive |
|---|---|---|
| Peanut (liquid peanut extract) SLIT | Experimental | After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months. Receives: Drug: Liquid Peanut Extract |
| Placebo Glycerin SLIT | Placebo comparator | After the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months. Receives: Drug: Placebo Glycerin SLIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desensitization After 36 Months of Peanut SLIT or Placebo SLIT
The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization).
DBPCFC Challenge Score scale:
Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
Measured: 36 months
Secondary outcomes (5)
Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT
A secondary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
DBPCFC Challenge Score scale:
Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
Measured: 39 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE)
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-specific IgE measured at baseline and at completion of peanut SLIT (36 months). Change in IgE reported in kUA/L.
Measured: 0 months to 36 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4)
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-specific IgG4 measured at baseline and at completion of peanut SLIT (36 months). Change in IgG4 reported in mg/L.
Measured: 0 months to 36 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test)
The change in immune parameters over time associated with the induction of clinical desensitization compared to the failure to achieve clinical desensitization.
Peanut-skin prick test measured at baseline and at completion of peanut SLIT (36 months). Change in skin prick test reported in mm wheal diameter.
Measured: 0 months to 36 months
Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT
Incidence of all serious adverse events from initial enrollment through the end of the 3 month avoidance period reported as the number of participants experiencing a serious adverse event.
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Research & Education, National Center for Complementary and Integrative Health (NCCIH), University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Wesley Burks, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304991
- Sponsor's protocol ID
- 14-0648
- Other IDs
- R01AT004435-07
- Acronym
- FARE/SLIT
- Status last verified
- Jan 2021
- First submitted
- 21 Nov 2014
- Last updated
- 10 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children
- ClinicalTrials.gov ID
- NCT02304991
- Acronym / sponsor ID
- FARE/SLIT / 14-0648
- Keywords
- Peanut, Food Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Food Allergy Research & Education, National Center for Complementary and Integrative Health (NCCIH), University of Texas Southwestern Medical Center
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Posted 16 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months]
Secondary Objectives:
A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein.
[Time Frame: Baseline, 39 months]
Detailed description
Peanut allergy is one of the most common food allergies; most children develop this allergy early in life, do not outgrow it and are at risk for severe and life-ending anaphylactic reactions. There is a critical need for a proactive treatment for peanut allergy and the investigators along with others are developing specific types of immunotherapy that will act as disease-modifying therapies.
This SLIT study is a randomized, blinded, placebo-controlled study. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC performed after 36 months of peanut SLIT (desensitization). A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
Upon enrollment into the study, all subjects will undergo a qualifying entry DBPCFC with peanut protein to confirm the diagnosis of peanut allergy and establish a baseline threshold level. Following a positive DBPCFC, each subject will be randomized 1:1 to receive peanut SLIT therapy versus placebo for a duration of 36 months. DBPCFC will be repeated for both active and placebo subjects at 36 months to assess desensitization and at 39 months to assess tolerance.
Outcome variables of interest include peanut specific IgE, IgG, and IgG4, basophil activation, mast cell responses through skin prick testing, and specific T-cell cytokine responses and T regulatory cell (TReg) activation.
COVID-19 SAFETY MEASURES- Reflected in Protocol V4.0- April 2020
In March of 2020, State and National emergencies were declared over the global pandemic coronavirus COVID-19.
As such, any 36 month Desensitization DBPCFC will be postponed while the safety measures surrounding COVID-19 are in place. Subjects who choose to remain in the study will continue on study drug at the maintenance dose level beyond the originally planned 36 months until such time that the Desensitization DBPCFC is conducted.
Subjects who are scheduled to undergo the 39 month Tolerance DBPCFC while the COVID-19 safety measures are in place will have their DBPCFC cancelled. Additional time off of study drug therapy would potentially increase the risk of allergic reaction during the DBPCFC and would not be acceptable.
For subjects whose Desensitization DBPCFC is postponed, a followup visit to review safety and subject dosing diaries would be conducted. This visit would be conducted remotely by telephone. Additional study drug would be sent direct-to-patient as necessary to continue on maintenance dosing. Lab sample collection and mechanistic studies would be deferred and be completed at the time that the Desensitization DBPCFC is completed. The Tolerance DBPCFC would be completed 3 months after the Desensitization DBPCFC is completed.
For subjects whose Tolerance DBPCFC is canceled, an exit visit would be conducted to review safety. The subject would be unblinded to treatment allocation and end of study instructions would be reviewed with the subject.
As the situation is changing daily, we are unable to provide a time frame for extension. We hope to limit the number of subjects who will need to utilize this option and preserve the endpoint data parameters. Previous SLIT studies have not shown any additional risk with peanut SLIT dosing beyond 3 years up to a total of 5 years of dosing.
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 |
|---|---|---|
| Peanut (liquid peanut extract) SLIT | Experimental | Drug: Liquid Peanut ExtractAfter the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to peanut SLIT therapy will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months. |
| Placebo Glycerin SLIT | Placebo comparator | Drug: Placebo Glycerin SLITAfter the entry DBPCFC, subjects will be randomized 1:1 to active or placebo drug product. Subjects randomized to placebo glycerin SLIT will dose for 36 months and undergo a second DBPCFC. The subjects will stop dosing for three months and repeat a DBPCFC at 39 months. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent from participant's parent/guardian.
- Age 12-48 months of either sex, any race, any ethnicity.
- A peanut allergy diagnosis with a convincing clinical history of peanut allergy and a serum peanut-specific IgE [UniCAP] > 0.35 kUA/L AND a positive skin prick test to peanut (>3 mm than the negative control) OR are sensitized to peanut (based on a serum IgE [UniCAP] to peanut of > 5 kUA/L) AND a positive skin prick test to peanut (> 3 mm than the negative control) and no known history of ingestion of peanut.
- A positive DBPCFC to 1000 mg of peanut at enrollment.
Key exclusion criteria (9 listed)
- History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or peripheral capillary oxygen saturation (SpO2) < 92% at any stage, hypotension, confusion, collapse or loss of consciousness).
- Participation in any interventional study for the treatment of food allergy in the past 6 months.
- Known oat, wheat, or glycerin allergy.
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease.
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 - Appendix 2).
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 |
|---|---|---|
| Liquid Peanut ExtractAlso: SLIT5000mcg/ml peanut protein | Drug | Peanut (liquid peanut extract) SLIT |
| Placebo Glycerin SLITAlso: SLITpure glycerinated saline solution with caramel coloring to match color | Drug | Placebo Glycerin SLIT |
Primary outcome
Desensitization After 36 Months of Peanut SLIT or Placebo SLIT
Time frame: 36 months
The primary outcome of this study will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during DBPCFC after 36 months of peanut SLIT (desensitization). DBPCFC Challenge Score scale: Minimum score = 0; Maximum score = 7 Larger challenge score equals more successful desensitization. 0mg = 0; 3mg = 1; 13mg = 2; 43mg = 3; 143mg = 4; 443mg = 5; 1443mg = 6; and 4443mg = 7.
5 secondary outcomes
Tolerance 3 Months After Discontinuing Peanut SLIT or Placebo SLIT
Time frame: 39 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgE)
Time frame: 0 months to 36 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut-specific IgG4)
Time frame: 0 months to 36 months
Change in Immune Parameters With Peanut SLIT Versus Placebo SLIT (Peanut Skin Prick Test)
Time frame: 0 months to 36 months
Number of Participants Experiencing Serious Adverse Events With Peanut SLIT Versus Placebo SLIT
Time frame: 39 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Wesley Burks, MD principal investigator
University of North Carolina, Chapel Hill
2 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 Liquid Peanut Extract in people with Peanut Hypersensitivity and Food Allergy, run by University of North Carolina, Chapel Hill 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 4 inclusion and 9 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 10 Jan 2022. 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. 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 16 Dec 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?
Desensitization After 36 Months of Peanut SLIT or Placebo SLIT (time frame: 36 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 10 Jan 2022.