Acalabrutinib for Peanut and Tree Nut Allergies

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether acalabrutinib (also known as Calquence or ACP-196) can prevent serious allergic reactions, such as anaphylaxis, in individuals with food allergies to peanuts or tree nuts. The goal is to determine if this medication can stop or reduce symptoms during a controlled food challenge, where a person consumes a small amount of the allergen under medical supervision. This trial may suit adults who have experienced allergic reactions to peanuts or tree nuts and have shown a positive skin test to these foods. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that acalabrutinib is likely to be safe for humans?

Research has shown that acalabrutinib is generally well-tolerated by people who have used it for other conditions. Common side effects include headaches, diarrhea, and infections, though not everyone experiences these. Some individuals have reported serious bleeding problems, so discussing risk factors with a doctor is important. Acalabrutinib has been used in other treatments for some time, and no new safety issues have emerged. This suggests it might be a safe option for preventing food allergies, but staying informed and cautious remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for preventing anaphylaxis focus on avoiding allergens or using medications like antihistamines and epinephrine to manage symptoms. But acalabrutinib works differently, targeting a protein called Bruton's tyrosine kinase (BTK) involved in the immune response. This unique mechanism could potentially stop severe allergic reactions before they start, rather than just treating symptoms after they occur. Researchers are excited about acalabrutinib because it offers a new way to prevent anaphylaxis, potentially reducing the need for emergency interventions like epinephrine auto-injectors.

What evidence suggests that acalabrutinib might be an effective treatment for food allergies?

Research has shown that acalabrutinib, the treatment being tested in this trial, could be a promising option because it targets specific proteins involved in allergic reactions. Early results suggest it can reduce symptoms and prevent severe reactions like anaphylaxis, a serious allergic reaction. Although most current data comes from cancer studies, the mechanism of acalabrutinib might also help with food allergies. By blocking certain proteins, it could potentially stop the chain reaction leading to anaphylaxis. This trial aims to test its effectiveness for food allergies as well. ^{6 7 8 9 10}

Who Is on the Research Team?

Melanie C. Dispenza, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Acalabrutinib

How Is the Trial Designed?

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

Citations

1. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/5151/503709/Real-World-Effectiveness-and-Safety-Outcomes-of

Real-World Effectiveness and Safety Outcomes of ... The 18-month OS rate was 90% and 85% for the 1L and 2L+ cohorts, respectively ( Figure 2). After initiation of acalabrutinib treatment, the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40736551/

Real-world efficacy and safety outcomes of acalabrutinib in ... Real-world efficacy and safety outcomes of acalabrutinib in chronic lymphocytic leukemia: primary results of a French multicentre observational ...

3. calquence.com calquence.com/why-calquence/how-effective-calquence-cll.html

How Effective Is CALQUENCE® (acalabrutinib)? | CLL 92% (165 of 179) of people on CALQUENCE + immunotherapy* had no cancer growth or spread compared to 47% (84 of 177) of people on chemoimmunotherapy.†. 80% Down ...

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2024/calquence-acalabrutinib-plus-chemoimmunotherapy-reduced-the-risk-of-disease-progression-or-death-by-27-percentage-vs-standard-of-care-in-patients-with-untreated-mantle-cell-lymphoma-in-echo-phase-iii-trial.html

CALQUENCE® (acalabrutinib) plus chemoimmunotherapy ... Results showed the CALQUENCE combination regimen reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1509981

Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic ... In this study, the selective BTK inhibitor acalabrutinib had promising safety and efficacy profiles in patients with relapsed CLL, including those with ...

6. calquencehcp.com calquencehcp.com/mcl/ace-ly-004/safety-data.html

ACE-LY-004 Safety Data - Calquence The 38-month safety profile was consistent with initial analysis · The most common TEAEs (≥20%) were infections (68%), headache (39%), diarrhea (37%), bleeding ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33907299/

Pooled analysis of safety data from clinical trials ... - PubMed This pooled analysis confirmed acalabrutinib's tolerability and identified no newly emerging late toxicities, supporting acalabrutinib as a long-term treatment.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/210259s011lbl.pdf

Reference ID: 5512932 - accessdata.fda.gov The safety data described in this section reflect exposure to CALQUENCE (100 mg approximately every. 12 hours) in 124 patients with previously treated MCL in ...

9. calquence.com calquence.com/safety-isi.html

Safety Information about CALQUENCE® (acalabrutinib). Bleeding problems (hemorrhage) have happened in people treated with CALQUENCE and can be serious and may lead to death. Your risk of bleeding may increase if ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf

CALQUENCE® (acalabrutinib) tablets, for oral use The safety data described in this section reflect exposure to CALQUENCE (100 mg approximately every. 12 hours) in 124 patients with previously ...