Preventing Anaphylaxis With Acalabrutinib

NCT05038904 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00223615
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy; Food Allergy Peanut

Keywords

Anaphylaxis; Peanut allergy; Tree nut allergy; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 2 of treatment

Secondary Outcomes (3)

• Area Under the Curve Severity of Clinical Reaction to Peanut

  Baseline and Day 2 of treatment

• Skin Prick Test Size to Peanut

  Baseline and Day 2 of treatment

• Basophil Activation Testing

  Baseline and Day 2 of treatment

Study Arms (1)

Acalabrutinib

EXPERIMENTAL

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

Drug: Acalabrutinib

Interventions

Acalabrutinib DRUG

100 mg oral capsule

Also known as: Calquence

Acalabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• AstraZeneca: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 37384412 RESULT

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity; Anaphylaxis; Nut Hypersensitivity; Hypersensitivity

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Nut and Peanut Hypersensitivity

Limitations and Caveats

Limitations included a small patient population, the lack of fully blinded oral food challenges, and the lack of placebo treatment arm. Additionally, this trial did not investigate alternative durations or dosages of acalabrutinib; therefore, the minimum effective duration and dose are as yet undetermined.

Results Point of Contact

• Title: Melanie C. Dispenza, MD, PhD
• Organization: Johns Hopkins University School of Medicine

mdispen1@jhmi.edu

410-550-2301

Study Officials

• Melanie C. Dispenza, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 9, 2021
• Study Start: December 16, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 31, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)