18 and older, any sex, with Food Allergy or Food Allergy Peanut. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Highest Dose of Peanut That is Tolerated During Oral Food ChallengePrimary· Baseline and Day 2 of treatment
The highest dose of peanut protein (in mg) tolerated during oral food challenge before and after acalabrutinib treatment was determined by assessing clinical symptoms and physcial exam findings in each organ system during the challenge. Symptoms were given a numeric score based on the American Academy of Allergy, Asthma, and Immunology/European Academy of Allergy and Clinical Immunology PRACTALL consensus system to grade symptom severity and the likelihood of their representing a true objective clinical reaction to peanut.
Baseline
Group
Value
95% CI
Acalabrutinib
29
1 – 444
Aftet treatment
Group
Value
95% CI
Acalabrutinib
4,044
444 – 4,044
Area Under the Curve Severity of Clinical Reaction to PeanutSecondary· Baseline and Day 2 of treatment
The severity of participants' cliinical reaction during oral food challenge before and after acalabrutinib treatment was determined using the American Academy of Allergy, Asthma, and Immunology/European Academy of Allergy and Clinical Immunology PRACTALL consensus system to grade objective clinical findings on physical exam on a scale of 0 (absent) to 3 (severe) in 9 different organ system categories. Total symptom scores for each food dose ranged from a minimum if 0 (no symptoms) to 27 (severe objective symptoms in all organ systems), and the area under the curve for all scores during the foo
Baseline
Group
Value
95% CI
Acalabrutinib
27.83
15.91 – 39.75
After treatment
Group
Value
95% CI
Acalabrutinib
3.76
0.12 – 7.39
Skin Prick Test Size to PeanutSecondary· Baseline and Day 2 of treatment
The skin prick test to peanut extract wheal area (in square mm) was measured at baseline and after treatment.
Baseline
Group
Value
95% CI
Acalabrutinib
126
27.5 – 480
After treatment
Group
Value
95% CI
Acalabrutinib
57.7
0 – 345
Basophil Activation TestingSecondary· Baseline and Day 2 of treatment
The percent of peripheral blood basophils activated by stimulation ex vivo with peanut extract was assessed by CD63 surface expression.
Baseline
Group
Value
95% CI
Acalabrutinib
31.7
3.5 – 70.7
After treatment
Group
Value
95% CI
Acalabrutinib
1.56
0 – 4.6
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Acalabrutinib
Serious: 3/10 (30%)
Deaths: 0/10
Serious adverse events (3 terms)
Reaction
System
Acalabrutinib
Sports-related concussion
Injury, poisoning and procedural complications
—
Sports-related injury
Injury, poisoning and procedural complications
—
Emergency room visit after baseline food challenge
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07257055 — Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WIN
· Phase 2
· recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel
· Phase 3
· recruiting
NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2
· Phase 2
· not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
· not yet recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
· Phase 2
· recruiting
Other recruiting trials for Food Allergy
Currently open trials in the same condition.
NCT07210320 — PK/PD Study of IN-001 Sublingual Spray in Healthy Adults
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 28 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05038904.