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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

Study Summary

This trial is testing if a drug can prevent food allergies in adults.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Highest Dose of Peanut That is Tolerated During Oral Food Challenge
Secondary outcome measures
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%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
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
~2030

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,061 Total Patients Enrolled
3 Trials studying Food Allergy
75 Patients Enrolled for Food Allergy
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,776 Total Patients Enrolled
Melanie C. Dispenza, MD, PhDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are engaged in the clinical trial?

"Affirmative. Clinicaltrials.gov provides evidence that suggests this medical trial is currently enrolling participants, with the advertisement being first posted on December 16th 2021 and updated more recently in the month of December. 10 people are necessary to be enlisted from a single site."

Answered by AI

What medical conditions can be managed by Acalabrutinib?

"Acalabrutinib has been identified as a potential treatment option for Mantle cell lymphoma, Small Lymphocytic Lymphoma and Chronic Lymphycytic Leukemia."

Answered by AI

Are there currently any openings for prospective participants in this study?

"Clinicaltrials.gov confirms that this medical trial is currently recruiting volunteers, with the initial posting on December 16th 2021 and most recent update being made on the 30th of that same month."

Answered by AI

Is this trial a pioneering venture into new medical research?

"In 2014, Acerta Pharma BV first initiated a clinical trial to assess the efficacy of acalabrutinib. After 306 participants were analysed in Phase 1 & 2 trials, it was approved for drug use and is now part of 75 active medical investigations spread out over 507 cities and 47 countries worldwide."

Answered by AI

Have there been any follow-up studies involving Acalabrutinib?

"Currently, 75 Acalabrutinib studies are ongoing with 11 trials in Phase 3. Although there is a concentration of such research in Houston, Texas, the drug is being investigated at over 2 thousand and four hundred sites globally."

Answered by AI

Is Acalabrutinib a viable option for patients in terms of safety?

"Data collected thus far has indicated that acalabrutinib is safe, garnering it a score of 2. This Phase 2 trial does not yet have evidence supporting its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preventing Anaphylaxis With Acalabrutinib
2021. "Preventing Anaphylaxis With Acalabrutinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038904.
~3 spots leftby Apr 2025
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