Phase 2
N=10
Preventing Anaphylaxis With Acalabrutinib
Food Allergy · Food Allergy Peanut
Bottom Line
View on ClinicalTrials.gov: NCT05038904 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Sep 2023
Primary outcome: Primary: Highest Dose of Peanut That is Tolerated During Oral Food Challenge — 29; 4,044 mg — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acalabrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Highest Dose of Peanut That is Tolerated During Oral Food Challenge |
29; 4,044 | 0.002 sig |
| SECONDARY Area Under the Curve Severity of Clinical Reaction to Peanut |
27.83; 3.76 | 0.0014 sig |
| SECONDARY Skin Prick Test Size to Peanut |
126; 57.7 | 0.002 sig |
| SECONDARY Basophil Activation Testing |
31.7; 1.56 | 0.002 sig |
Summary
Food allergy is a potentially life-threatening condition, and its prevalence continues to increase despite public health efforts. There are currently no known therapies that can reliably prevent food-induced anaphylaxis. This is an open-label study designed to determine the ability acalabrutinib to prevent signs and symptoms of anaphylaxis during an oral food challenge in food-allergic adults.
Eligibility Criteria
Inclusion Criteria
- History of immunoglobulin E (IgE)-mediated food allergy to peanut or tree nut
- Positive skin prick test to the trigger food (either peanut or tree nut)
- Objective clinical reaction to the food allergen during baseline oral food challenge
- 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 7 days following completion of acalabrutinib therapy.
- 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
Exclusion Criteria
- Participants who have been on immunomodulatory therapies or oral corticosteroids within 1 month prior to enrollment
- Participants with symptoms consistent with food reactions other than type 1 hypersensitivity
- History of allergic reaction to acalabrutinib
- History of idiopathic urticaria, dermatographism, idiopathic or unexplained anaphylaxis, or anaphylaxis (to foods or otherwise) resulting in intubation, prolonged hypotension, or neurological sequelae- History of cardiovascular disease
- History of a bleeding disorder, or those currently taking blood thinners
- History of stroke
- History of gastrointestinal ulcer
- History of cancer (other than skin cancer)
- Positive HIV status or history of other immunodeficiency
- Active or latent Hepatitis B or C infection based on laboratory testing
- Currently pregnant or nursing
- Current use of proton pump inhibitors (Note: participants currently receiving proton pump inhibitors who switch to H2-receptor antagonists or other antacids are eligible for enrollment to this study).
- Active significant infection
- Major surgical procedure within 28 days of enrollment
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- Difficulty swallowing oral medication, or significant gastrointestinal disease that would limit absorption of oral medication
- Concurrent participation in another therapeutic clinical trial
Data sourced from ClinicalTrials.gov (NCT05038904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.