Preventing Anaphylaxis With Acalabrutinib

Overseen By Ragha Suresh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Immunomodulators, Corticosteroids, Blood thinners, PPIs

Disqualifiers: Cardiovascular disease, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 2 days

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking immunomodulatory therapies, oral corticosteroids, and proton pump inhibitors before enrolling. If you are on proton pump inhibitors, you can switch to H2-receptor antagonists or other antacids to be eligible.

Research Team

Melanie C. Dispenza, MD, PhD

Principal Investigator

Johns Hopkins University

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

Exclusion Criteria

You have had cancer in the past, except for skin cancer.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Oral Food Challenge

Participants undergo an oral food challenge to determine baseline reactivity to peanut or tree nuts

1 day

1 visit (in-person)

Treatment

Participants take 4 oral doses of acalabrutinib 100 mg to assess its effect on reducing reactivity to peanut or tree nuts

2 days

2 visits (in-person)

Follow-up Oral Food Challenge

Participants repeat the oral food challenge to evaluate the effect of acalabrutinib on food reactivity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acalabrutinib

Participant Groups

Group I: Acalabrutinib Experimental Treatment 1 Intervention

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

Acalabrutinib is already approved in United States, European Union for the following indications:

Approved in United States as Calquence for:

• Mantle cell lymphoma
• Chronic lymphocytic leukemia
• Small lymphocytic lymphoma

Approved in European Union as Calquence for:

• Chronic lymphocytic leukemia
• Small lymphocytic lymphoma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology