Food HypersensitivityPhase 2SLBNCT00597727

A Study of Sublingual Immunotherapy in Peanut-allergic Children

A Phase 2 study testing Peanut SLIT in people with Food Hypersensitivity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children. Read more about this study

Who is it for?: Ages 1 year to 11 years
Conditions the study is for: Food Hypersensitivity
What is being tested?: Peanut SLIT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Mar 2016
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 1 year to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND
History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Who cannot join

History of severe life-threatening anaphylaxis to peanut, OR
Medical history that would prevent a DBPCFC to peanut, OR
Subjects with wheat or oat allergy (which are used in the placebo), OR
Unable to cooperate with challenge procedures, OR
Unable to be reached by telephone for follow-up

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

Read the detailed description

In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.

Conditions: Food Hypersensitivity
Being tested: Peanut SLIT, Placebo SLIT
Keywords: Peanut Allergy, Sublingual immunotherapy
Medical subject headings: Food Hypersensitivity, Peanut Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peanut SLITDrug
Also called Sublingual peanut protein drops
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
Placebo SLITDrug
Also called Sublingual glycerin saline drops
Liquid glycerin without peanut which are dosed under the tongue.

Study groups in NCT00597727
Study group	Role	What they receive
Blinded Peanut SLIT	Active comparator	Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. Receives: Drug: Peanut SLIT
Blinded Placebo SLIT	Placebo comparator	Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. Receives: Drug: Placebo SLIT
Ext. maint. open label peanut SLIT	Other	After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study. Receives: Drug: Peanut SLIT
Early unblinded peanut SLIT	Other	Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort. Receives: Drug: Peanut SLIT
Pilot peanut SLIT rollover cohort	Other	Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort. Receives: Drug: Peanut SLIT

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing
Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.
Measured: 12 months

Secondary outcomes (1)

Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing
Upon completion of 36-60 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. Peanut SLIT therapy was then discontinued for 2-4 weeks to assess for persistence of the desensitization response called sustained unresponsiveness (SU). The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5000 mg peanut protein DBPCFC without developing symptoms 2-4 weeks after discontinuing peanut SLIT therapy.
Measured: 36-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2016

First posted18 Jan 2008 (estimated)
Study startJan 2008
Primary completionMar 2016
Study completionMar 2016

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 (3)Papers the sponsor has linked to this study.
Other trials for Food HypersensitivityStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe 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: Crossover
Model description: For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment. After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months) 2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00597727
Sponsor's protocol ID: 11-2296
Other IDs: 5R01AT004435-09
Acronym: SLB
Status last verified: Apr 2017
First submitted: 7 Jan 2008
Last updated: 27 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. No abstract available.
PubMed 23534975
Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: 10.1016/j.jaci.2010.12.1083. Epub 2011 Feb 1.
PubMed 21281959
Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. doi: 10.1016/j.jaci.2011.11.045. Epub 2012 Jan 10.
PubMed 22236732

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Food Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT
ClinicalTrials.gov ID: NCT00597727
Acronym / sponsor ID: SLB / 11-2296
Conditions: Food Hypersensitivity
Keywords: Peanut Allergy, Sublingual immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2008
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Jan 2008 (estimated)
Results: Posted 18 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5
Model description: For the initial 12 months of the study, subjects were blinded to receive either peanut SLIT or placebo. After unblinding, subjects on placebo are crossed over to receive open-label peanut SLIT. They underwent an identical dosing protocol as those that were initially randomized to active treatment. After 12 months of peanut SLIT dosing, whether initially randomized to active or crossed over from placebo, all subjects remained part of an open-label extended maintenance phase for the duration of the study (total peanut SLIT dosing 36-60 months) 2 additional cohorts were included in the protocol. One cohort, called the Early Unblinded Peanut SLIT cohort, was unblinded prior to the scheduled 12 month time point for pharmacy safety concerns. The second cohort, called the Pilot Peanut SLIT Rollover cohort involved subjects from the prior pilot study (NCT00429429) who were added to the study through an amendment and received open-label peanut SLIT.

Arm	Type	Receives
Blinded Peanut SLIT	Active comparator	Drug: Peanut SLITBlinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study.
Blinded Placebo SLIT	Placebo comparator	Drug: Placebo SLITBlinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study.
Ext. maint. open label peanut SLIT	Other	Drug: Peanut SLITAfter completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study.
Early unblinded peanut SLIT	Other	Drug: Peanut SLITSubjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort.
Pilot peanut SLIT rollover cohort	Other	Drug: Peanut SLITSubjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND
History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Key exclusion criteria (5 listed)

History of severe life-threatening anaphylaxis to peanut, OR
Medical history that would prevent a DBPCFC to peanut, OR
Subjects with wheat or oat allergy (which are used in the placebo), OR
Unable to cooperate with challenge procedures, OR
Unable to be reached by telephone for follow-up

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 SLITAlso: Sublingual peanut protein dropsLiquid peanut protein drops diluted in glycerin which are dosed under the tongue.	Drug	Blinded Peanut SLIT, Early unblinded peanut SLIT, Ext. maint. open label peanut SLIT, Pilot peanut SLIT rollover cohort
Placebo SLITAlso: Sublingual glycerin saline dropsLiquid glycerin without peanut which are dosed under the tongue.	Drug	Blinded Placebo SLIT

Primary outcome

Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing
Time frame: 12 months
Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 months of peanut SLIT therapy.

1 secondary outcome

Percentage of Subjects Tolerating a Peanut Oral Food Challenge 2-4 Weeks After Discontining Peanut SLIT Dosing
Time frame: 36-60 months

Results and safety

Results posted to the registry on 18 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Blinded Peanut SLIT	14	14
Blinded Placebo SLIT	15	15
Ext Maint Open Label Peanut SLIT	0	0
Early Unblinded Peanut SLIT	27	17
Pilot Peanut SLIT Rollover Cohort	4	3

Primary outcome: Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Blinded Peanut SLIT n = 11	Blinded Placebo SLIT n = 7	Early Unblinded Peanut SLIT n = 17	Pilot Peanut SLIT Rollover Cohort n = 3
Value	45.5	0	11.8	66.7

Population analysed: Interim analysis in 7/2010 showed statistically significant difference in peanut tolerated during oral food challenge (OFC) by active treatment vs placebo (1710mg vs 85mg). Further OFCs for those on placebo was considered more risk than benefit thus were discontinued resulting in subsequent patients being unblinded after 12 months without an OFC

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected from the initial day of study drug dosing through unblinding after 12 months of therapy continuing through the extended maintenance phase for a total of 36-60 months of treatment concluding with the end of study DBPCFC 2-4 weeks off of peanut SLIT therapy.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Blinded Peanut SLIT	0 of 14 (0%)	10 of 14 (71.4%)	0 of 14
Blinded Placebo SLIT	0 of 15 (0%)	12 of 15 (80%)	0 of 15
Ext Maint Open Label Peanut SLIT	0 of 29 (0%)	21 of 29 (72.4%)	0 of 29
Early Unblinded Peanut SLIT	0 of 27 (0%)	19 of 27 (70.4%)	0 of 27
Pilot Peanut SLIT Rollover Cohort	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Limitations and caveats (from the sponsor): The initial 27 subjects in the study were unblinded in 12/2009 due to concerns for study drug integrity. These subjects were offered reentry into the study on open label drug. 18 accepted and are presented as the Early Unblinded Peanut SLIT cohort.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23534975Chin SJ, Vickery BP, Kulis MD, Kim EH, Varshney P, Steele P, Kamilaris J, Hiegel AM, Carlisle SK, Smith PB, Scurlock AM, Jones SM, Burks AW. Sublingual versus oral immunotherapy for peanut-allergic children: a retrospective comparison. J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2. doi: 10.1016/j.jaci.2013.02.017. Epub 2013 Mar 25. No abstract available.
Results publication: PubMed 21281959Kim EH, Bird JA, Kulis M, Laubach S, Pons L, Shreffler W, Steele P, Kamilaris J, Vickery B, Burks AW. Sublingual immunotherapy for peanut allergy: clinical and immunologic evidence of desensitization. J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1. doi: 10.1016/j.jaci.2010.12.1083. Epub 2011 Feb 1.
Results publication: PubMed 22236732Kulis M, Saba K, Kim EH, Bird JA, Kamilaris N, Vickery BP, Staats H, Burks AW. Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapy. J Allergy Clin Immunol. 2012 Apr;129(4):1159-62. doi: 10.1016/j.jaci.2011.11.045. Epub 2012 Jan 10.
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

1 site 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 SLIT in people with Food Hypersensitivity, run by University of North Carolina, Chapel Hill 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 2 inclusion and 5 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 27 Mar 2018. 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. 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 18 May 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?

Percentage of Subjects Who Can Tolerate the Peanut Oral Food Challenge After 12 Months of Peanut SLIT Dosing (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 NCT00597727, which also lists 3 linked publications.

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 27 Mar 2018.