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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 2 of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 2 of treatment
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 • NCT043461992%
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
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
~2050
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,899 Total Patients Enrolled
3 Trials studying Food Allergy
75 Patients Enrolled for Food Allergy
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,799 Total Patients Enrolled
Melanie C. Dispenza, MD, PhDPrincipal InvestigatorJohns Hopkins University
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