Food AllergyPhase 2NCT03149315
Inhibition of Anaphylaxis by Ibrutinib
A Phase 2 study testing Ibrutinib in people with Food Allergy and Anaphylaxis Food, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Allergy, Anaphylaxis Food
- What is being tested?
- Ibrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 14 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of food allergy to peanut (or tree nut).
- Male or female age ≥ 18 years.
- Positive skin prick testing and basophil activation test to the trigger food, either peanut or tree nut.
- Adequate organ and marrow function as defined below:
- leukocytes ≥ 3,000/mcL
- absolute neutrophil count ≥ 1,500/mcL
Show all 16Show fewer
- platelets ≥ 100,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) within normal institutional limits
- Creatinine within normal institutional limits
- Women of child bearing potential must agree to two forms of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.
- A female of child bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
- Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, subjects must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.
Who cannot join
- Subjects who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to study participation will be excluded, and those taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with SPT responses.
- Subjects with symptoms not consistent with type 1 food reactions (atopic dermatitis, eosinophilic esophagitis and any other non-IgE-mediated food sensitivities) will be excluded.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, beta-blocker use or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Subjects on anticoagulants, anti-platelet therapy, or any other predisposition towards bleeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
About this study
This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to adults with food allergy to inhibit food allergy responses.
Read the detailed description
This is open-label study designed to determine the fewest doses and shortest length of time, from two days to up to 7 days, needed for ibrutinib to fully inhibit tests for food allergy, and to determine the length of persistence of efficacy after the drug is stopped.
- Conditions
- Food Allergy, Anaphylaxis Food
- Being tested
- Ibrutinib
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called Ibruvica
Ibrutinib 420mg, PO once daily for 2-7 days
| Study group | Role | What they receive |
|---|---|---|
| Open Label Administration | Experimental | Allergic subjects will be given ibrutinib 420mg daily for 2-7 doses to determine the shortest amount of time and fewest ibrutinib doses required to suppress food skin prick testing and basophil activation test reactivity. Receives: Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods
The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).
Measured: 7 days
Secondary outcomes (2)
Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity
The primary outcome was to determine the fewest ibrutinib doses (2, 4, or 7 doses) required to suppress basophil reactivity (BAT). All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Basophil activation testing was perfmored at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).
Measured: 7 days
Time to Recovery of Skin Test Reactivity
Another secondary outcome was to determine the timing of when skin prick testing (SPT) response to peanut or tree nuts returned to baseline compared to basophil activation test (BAT) responses. Participants underwent SPT and BAT weekly after cessation of ibrutinib therapy. SPT and BAT that were ≥80% of baseline values were considered to have "returned to baseline."
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start10 Apr 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
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 Food 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Melanie c Dispenza, MD, PhD, Northwestern University
- Investigators
- Anne Marie Singh, MD, Principal investigator, Ann & Robert H. Lurie Childrens HospitalBruce Bochner, MD, Principal investigator, Northwestern Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149315
- Sponsor's protocol ID
- 2016-357
- Status last verified
- Jan 2025
- First submitted
- 5 May 2017
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dispenza MC, Pongracic JA, Singh AM, Bochner BS. Short-term ibrutinib therapy suppresses skin test responses and eliminates IgE-mediated basophil activation in adults with peanut or tree nut allergy. J Allergy Clin Immunol. 2018 May;141(5):1914-1916.e7. doi: 10.1016/j.jaci.2017.12.987. Epub 2018 Jan 31. No abstract available.
PubMed 29360526
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Anaphylaxis by Ibrutinib
- ClinicalTrials.gov ID
- NCT03149315
- Acronym / sponsor ID
- 2016-357
- Conditions
- Food Allergy, Anaphylaxis Food
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II open label study on the use of Ibrutinib on the inhibition of food-induced anaphylaxis in adults with food allergy. Ibrutinib (brand name Imbruvica) is currently FDA approved for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulineia (WM). We propose to administer this approved drug to adults with food allergy to inhibit food allergy responses.
Detailed description
This is open-label study designed to determine the fewest doses and shortest length of time, from two days to up to 7 days, needed for ibrutinib to fully inhibit tests for food allergy, and to determine the length of persistence of efficacy after the drug is stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Administration | Experimental | Drug: IbrutinibAllergic subjects will be given ibrutinib 420mg daily for 2-7 doses to determine the shortest amount of time and fewest ibrutinib doses required to suppress food skin prick testing and basophil activation test reactivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- History of food allergy to peanut (or tree nut).
- Male or female age ≥ 18 years.
- Positive skin prick testing and basophil activation test to the trigger food, either peanut or tree nut.
- Adequate organ and marrow function as defined below:
- leukocytes ≥ 3,000/mcL
Key exclusion criteria (6 listed)
- Subjects who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to study participation will be excluded, and those taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with SPT responses.
- Subjects with symptoms not consistent with type 1 food reactions (atopic dermatitis, eosinophilic esophagitis and any other non-IgE-mediated food sensitivities) will be excluded.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, beta-blocker use or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
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 |
|---|---|---|
| IbrutinibAlso: IbruvicaIbrutinib 420mg, PO once daily for 2-7 days | Drug | Open Label Administration |
Primary outcome
Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods
Time frame: 7 days
The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib).
2 secondary outcomes
Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity
Time frame: 7 days
Time to Recovery of Skin Test Reactivity
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29360526Dispenza MC, Pongracic JA, Singh AM, Bochner BS. Short-term ibrutinib therapy suppresses skin test responses and eliminates IgE-mediated basophil activation in adults with peanut or tree nut allergy. J Allergy Clin Immunol. 2018 May;141(5):1914-1916.e7. doi: 10.1016/j.jaci.2017.12.987. Epub 2018 Jan 31. No abstract available.
- 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.
Anne Marie Singh, MD principal investigator
Ann & Robert H. Lurie Childrens Hospital
Bruce Bochner, MD principal investigator
Northwestern Feinberg School of Medicine
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 Ibrutinib in people with Food Allergy and Anaphylaxis Food, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 16 inclusion and 6 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 17 Jan 2025. 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 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 17 Jan 2025). 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 Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods (time frame: 7 days). 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 NCT03149315, 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 17 Jan 2025.