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Preventing Anaphylaxis With Acalabrutinib

Primary Purpose

Food Allergy, Food Allergy Peanut

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acalabrutinib

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Anaphylaxis, Peanut allergy, Tree nut allergy, Hypersensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acalabrutinib

Arm Description

Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice daily).

Outcomes

Primary Outcome Measures

Highest Dose of Peanut That is Tolerated During Oral Food Challenge

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.

Secondary Outcome Measures

Area Under the Curve Severity of Clinical Reaction to Peanut

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 food challenge were calculated for each participant.

Skin Prick Test Size to Peanut

The skin prick test to peanut extract wheal area (in square mm) was measured at baseline and after treatment.

Basophil Activation Testing

The percent of peripheral blood basophils activated by stimulation ex vivo with peanut extract was assessed by CD63 surface expression.

Full Information

NCT ID

NCT05038904

First Posted

August 26, 2021

Last Updated

September 27, 2023

Sponsor

Johns Hopkins University

Collaborators

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT05038904

Brief Title

Preventing Anaphylaxis With Acalabrutinib

Official Title

Preventing Life-Threatening Allergic Reactions With Acalabrutinib, an FDA-Approved Bruton's Tyrosine Kinase Inhibitor

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 16, 2021 (Actual)

Primary Completion Date

December 8, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

Approximately 15 million people (including 8% of children) in the US have a food allergy and are at risk for life-threatening systemic reactions to foods. There is an unmet need for treatments capable of preventing such reactions. This is a phase II, single-center, open label trial involving the use of acalabrutinib (brand name Calquence®) to prevent food-induced anaphylaxis in adults with food allergy. Acalabrutinib is FDA-approved to treat certain medical conditions, but it is not approved to treat allergies. Adult participants with a physician-diagnosed food allergy to peanut and/or tree nuts will be enrolled. These participants will undergo an oral food challenge to peanut or a tree nut under close physician supervision to determine participants' baseline reactivity. After a rest period, the participants will take 4 oral doses of acalabrutinib 100 mg, and then repeat the oral food challenge to see if acalabrutinib will reduce participants' reactivity to peanut or tree nuts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy, Food Allergy Peanut

Keywords

Anaphylaxis, Peanut allergy, Tree nut allergy, Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acalabrutinib

Arm Type

Experimental

Arm Description

Participants will be given acalabrutinib (four doses of 100 mg of acalabrutinib to be taken orally twice daily).

Intervention Type

Drug

Intervention Name(s)

Acalabrutinib

Other Intervention Name(s)

Calquence

Intervention Description

100 mg oral capsule

Primary Outcome Measure Information:

Title

Highest Dose of Peanut That is Tolerated During Oral Food Challenge

Description

Time Frame

Baseline and Day 2 of treatment

Secondary Outcome Measure Information:

Title

Area Under the Curve Severity of Clinical Reaction to Peanut

Description

Time Frame

Baseline and Day 2 of treatment

Title

Skin Prick Test Size to Peanut

Description

The skin prick test to peanut extract wheal area (in square mm) was measured at baseline and after treatment.

Time Frame

Baseline and Day 2 of treatment

Title

Basophil Activation Testing

Description

The percent of peripheral blood basophils activated by stimulation ex vivo with peanut extract was assessed by CD63 surface expression.

Time Frame

Baseline and Day 2 of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melanie C. Dispenza, MD, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

37384412

Citation

Suresh RV, Dunnam C, Vaidya D, Wood RA, Bochner BS, MacGlashan DW Jr, Dispenza MC. A phase II study of Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis. J Clin Invest. 2023 Aug 15;133(16):e172335. doi: 10.1172/JCI172335.

Results Reference

result

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Preventing Anaphylaxis With Acalabrutinib

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