Wheat AllergyPhase 1/2Wheat OITNCT01980992
Oral Immunotherapy for Wheat Allergy
A Phase 1/2 study testing Wheat OIT in people with Wheat Allergy, run by Hugh A Sampson, MD at 4 sites in United States.
Trial summary
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study… Read more about this study
- Who is it for?
- Ages 4 to 30 years
- Conditions the study is for
- Wheat Allergy
- What is being tested?
- Wheat OIT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2013to 13 Apr 2017
- 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 4 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 4-30 years either sex, any race, any ethnicity
- Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
- Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
- Written informed consent from subject and/or parent/guardian
- Written assent from all subjects as appropriate
- All females of child bearing age must be using appropriate birth control
Who cannot join
- History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
- Known allergy to corn
- Known celiac disease
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Active eosinophilic gastrointestinal disease in the past two years
- Participation in any interventional study for the treatment of food allergy in the past 6 months
Show all 14Show fewer
- Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
- A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
- Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
- Use of omalizumab or other non-traditional forms of allergen immunotherapy 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
- Use of investigational drug within 90 days or plan to use investigational drug during the study period
- Pregnancy or lactation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Icahn School of Medicine at Mount Sinai
New York, New York, 100029
Stanford University School of Medicine
Stanford, California, 94305
About this study
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
Read the detailed description
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
- Conditions
- Wheat Allergy
- Being tested
- Wheat OIT
- Keywords
- Food Allergy, Wheat Allergy, Oral Immunotherapy
- Medical subject headings
- Wheat Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat OITDrug
Also called Vital Wheat Gluten
Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
| Study group | Role | What they receive |
|---|---|---|
| Wheat OIT | Active comparator | Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol. Receives: Drug: Wheat OIT |
| Placebo | Placebo comparator | Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol. Receives: Drug: Wheat OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Measured: 1 Year
Secondary outcomes (4)
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.
Measured: 8 to 10 weeks after passing the 2 Year OFC
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.
Measured: 44 Weeks
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).
Measured: 2 Years
Incidence of All Serious Adverse Events During the Study.
Measured: 1 year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completion13 Apr 2017
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 Wheat AllergyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugh A Sampson, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hugh A Sampson, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Hugh A Sampson, MD, Study chair, Icahn School of Medicine at Mount SinaiHugh A Sampson, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980992
- Sponsor's protocol ID
- GCO 11-0197
- Other IDs
- FAI001
- Acronym
- Wheat OIT
- Status last verified
- Aug 2020
- First submitted
- 5 Nov 2013
- Last updated
- 14 Aug 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy for Wheat Allergy
- ClinicalTrials.gov ID
- NCT01980992
- Acronym / sponsor ID
- Wheat OIT / GCO 11-0197
- Conditions
- Wheat Allergy
- Keywords
- Food Allergy, Wheat Allergy, Oral Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hugh A Sampson, MDUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
Detailed description
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat OIT | Active comparator | Drug: Wheat OITActive treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol. |
| Placebo | Placebo comparator | Drug: Wheat OITPlacebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol. |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 4-30 years either sex, any race, any ethnicity
- Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
- Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
- Written informed consent from subject and/or parent/guardian
- Written assent from all subjects as appropriate
Key exclusion criteria (14 listed)
- History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
- Known allergy to corn
- Known celiac disease
- Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- Active eosinophilic gastrointestinal disease in the past two 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 |
|---|---|---|
| Wheat OITAlso: Vital Wheat GlutenVital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses. | Drug | Placebo, Wheat OIT |
Primary outcome
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
Time frame: 1 Year
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
4 secondary outcomes
Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
Time frame: 8 to 10 weeks after passing the 2 Year OFC
Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
Time frame: 44 Weeks
Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
Time frame: 2 Years
Incidence of All Serious Adverse Events During the Study.
Time frame: 1 year and 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Wheat Allergy
Not yet recruitingPhase 2
A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy
Food Allergy, Wheat Hypersensitivity
RecruitingObservational study
Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study
Metabolic Dysfunction-Associated Steatotic Liver Disease, Non Celiac Wheat Sensitivity
Active, not recruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Food Allergy
Recruiting
NCWS or IBS/FD in Relatives of CD Patients
Non Celiac Wheat Sensitivity, IBS (Irritable Bowel Syndrome)
Recruiting
Urinary Gluten Immunogenic Peptides Detection in Non-celiac Gluten/Wheat Sensitivity
Non-celiac Gluten/Wheat Sensitivity
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.
Hugh A Sampson, MD study chair
Icahn School of Medicine at Mount Sinai
Hugh A Sampson, MD principal investigator
Icahn School of Medicine at Mount Sinai
4 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 Wheat OIT in people with Wheat Allergy, run by Hugh A Sampson, MD at 4 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 6 inclusion and 14 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 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 31 Mar 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?
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment. (time frame: 1 Year). 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 14 Aug 2020.