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Bruton's Tyrosine Kinase Inhibitor

Acalabrutinib for Food Allergy

Phase 2
Waitlist Available
Led By Melanie C. Dispenza, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 2 of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a cancer drug called acalabrutinib can prevent severe allergic reactions in adults who are allergic to peanuts or tree nuts. Participants will take the drug and then eat peanuts or tree nuts under medical supervision to see if their allergic reactions are reduced.

Eligible Conditions
  • Food Allergy
  • Peanut Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 2 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 2 of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Highest Dose of Peanut That is Tolerated During Oral Food Challenge
Secondary study objectives
Area Under the Curve Severity of Clinical Reaction to Peanut
Basophil Activation Testing
Skin Prick Test Size to Peanut

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
Headache
1%
Septic shock
1%
Ischaemic stroke
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AcalabrutinibExperimental Treatment1 Intervention
Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2080

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,949 Total Patients Enrolled
3 Trials studying Food Allergy
75 Patients Enrolled for Food Allergy
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,647 Total Patients Enrolled
Melanie C. Dispenza, MD, PhDPrincipal InvestigatorJohns Hopkins University
~3 spots leftby Nov 2025
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