Abrocitinib for Food Allergy

Overseen By Alyssa Gontzes, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Dupilumab, Biologics, Steroids, others

Disqualifiers: Cardiovascular disease, Allergy to abrocitinib, others

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

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: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pill, abrocitinib, to determine if it can help people with food allergies without injections. Abrocitinib has successfully treated eczema, suggesting it might also work for food allergies. Participants will receive either a 100mg or 200mg dose of the drug. Suitable candidates have a diagnosed food allergy to peanuts, nuts, sesame, cod, or shrimp, have experienced allergic reactions, and currently avoid the food. This trial offers a valuable opportunity for those managing both food allergies and eczema. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, allowing participants to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable medication regimen, meaning you shouldn't start new medications or change dosages within 7 days or 5 half-lives before the trial and during it. Some medications, like certain biologics and steroids, need to be stopped for a specific period before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that abrocitinib has been tested for safety in conditions like atopic dermatitis, a type of skin condition. Studies have found that abrocitinib is generally well-tolerated. Some participants in these studies reported side effects, but they were usually manageable.

For instance, one study tested two doses, 100 mg and 200 mg, taken once a day. Participants experienced clearer skin and relief from itching, indicating the drug's effectiveness for skin conditions. Although some side effects were noted, they did not prevent most participants from continuing the treatment.

Since abrocitinib is already approved for atopic dermatitis, this supports its safety when used with medical supervision. However, because this new study focuses on food allergies, observing how people respond to the treatment for this specific condition is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for food allergies focus on avoiding allergens or managing reactions after exposure, such as with antihistamines or epinephrine. But Abrocitinib works differently, targeting the Janus kinase (JAK) pathway, which plays a role in the body's immune response. Researchers are excited about Abrocitinib because it offers a proactive approach, potentially reducing allergic reactions before they start. Plus, with two dosage options—100mg and 200mg—it provides flexibility in managing the severity of different allergies.

What evidence suggests that abrocitinib might be an effective treatment for food allergy?

Research has shown that abrocitinib can help treat atopic dermatitis, a skin condition often linked to food allergies. In clinical studies, many patients experienced clearer skin and less itching with abrocitinib. The treatment has proven safe and effective over the long term for those with moderate-to-severe atopic dermatitis. Some patients in these studies also had other allergies, such as asthma and food allergies, suggesting it might help with multiple allergic conditions. Overall, these findings indicate that abrocitinib could be a potential treatment for food allergies. Participants in this trial will receive either 100mg or 200mg of abrocitinib to evaluate its effectiveness specifically for food allergies. ^{1 2 5 6 7}

Who Is on the Research Team?

Emma Guttman, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Scott Sicherer, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 with IgE-mediated food allergies to specific foods like peanuts or shrimp, who have had allergic reactions and avoid these foods. They must be able to consent, not be pregnant or agree to contraception if applicable, stay in the Tri-State area during the study, and avoid UV light exposure.

Inclusion Criteria

I agree to stay out of the sun and not use UV light sources during the study.

My medication doses have been stable and I haven't started any new ones recently.

I am not pregnant and agree to use birth control or abstain from sex.

Exclusion Criteria

Unwilling or unable to give written informed consent or comply with protocol

I haven't taken any biologic medication in the last 12 weeks or 5 half-lives.

I haven't used steroids or undergone immunotherapy in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abrocitinib, an oral targeted medication, for food allergy treatment

16 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abrocitinib

Trial Overview The trial is testing abrocitinib, an oral medication previously used for atopic dermatitis, as a potential treatment for food allergies. It aims to provide a non-injection option that could treat both conditions in patients with multiple atopic disorders.

How Is the Trial Designed?

Group I: Abrocitinib 100mg Active Control 1 Intervention

This arm will receive 100mg of the study drug

Group II: Abrocitinib 200mg Active Control 1 Intervention

This arm will receive 200mg of the study drug

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

Approved in European Union as Cibinqo for:

• Moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy

Approved in United States as Cibinqo for:

• Refractory, moderate-to-severe atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Abrocitinib, an oral JAK1 inhibitor developed by Pfizer, has been approved in the UK and Japan for treating moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older.

The drug has also received a positive opinion from the European Medicines Agency and is under review in several other countries, indicating its potential as a new systemic therapy option for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abrocitinib: First Approval. Deeks, ED., Duggan, S.[2022]

In a study of 41 patients with difficult-to-treat moderate-to-severe atopic dermatitis (AD), abrocitinib significantly reduced disease severity over a median follow-up of 25 weeks, with EASI scores improving from 14.7 to 4.0 (p < 0.001).

Despite its effectiveness, 39% of patients discontinued abrocitinib due to ineffectiveness or adverse events, with common side effects including gastrointestinal symptoms (27.6%) and acne (20.7%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of abrocitinib treatment in patients with difficult-to-treat atopic dermatitis. Olydam, JI., Schlösser, AR., Custurone, P., et al.[2023]

The JAK inhibitor ruxolitinib significantly reduced anaphylactic symptoms and mast cell activation in a mouse model of food allergy, suggesting its potential as a therapeutic option.

Ruxolitinib's effectiveness was demonstrated by its ability to lower levels of specific antibodies and cytokines associated with allergic responses, indicating that JAK inhibition may be a promising strategy for managing food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remission of food allergy by the Janus kinase inhibitor ruxolitinib in mice. Yamaki, K., Yoshino, S.[2021]

In an open-label trial involving adults with IgE-mediated peanut allergy, acalabrutinib, a BTK inhibitor, significantly increased the median tolerated dose of peanut protein from 29 mg to 4,044 mg, demonstrating its potential efficacy in preventing allergic reactions.

The treatment was generally safe, with only four transient and nonserious adverse events reported among the ten participants, suggesting that acalabrutinib could be a promising option for enhancing food allergen tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis: an open-label, phase 2 trial. Suresh, RV., Dunnam, C., Vaidya, D., et al.[2023]

In a pooled analysis of 942 patients from three clinical trials, abrocitinib treatment significantly improved signs and symptoms of moderate-to-severe atopic dermatitis compared to placebo, with many patients achieving higher threshold efficacy responses.

Patients who met these higher efficacy thresholds reported greater quality-of-life benefits, indicating that abrocitinib not only alleviates symptoms but also enhances overall well-being in a meaningful way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High threshold efficacy responses in moderate-to-severe atopic dermatitis are associated with additional quality of life benefits: pooled analyses of abrocitinib monotherapy studies in adults and adolescents. Ständer, S., Bhatia, N., Gooderham, MJ., et al.[2022]

A birch pollen-allergic patient experienced a complete disappearance of apple-induced oral allergy syndrome after receiving omalizumab treatment, indicating a potential new use for this medication.

This case suggests that omalizumab may serve as an effective preventive treatment for individuals with severe type 1 food allergies, expanding its therapeutic applications beyond asthma and chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disappearance of severe oral allergy syndrome following omalizumab treatment. Asero, R.[2022]

In a study of 942 patients with moderate-to-severe atopic dermatitis, abrocitinib was found to be effective in improving skin condition and quality of life, regardless of the presence of allergic comorbidities like asthma or food allergies.

The treatment was associated with a higher percentage of patients achieving significant improvements in key measures of atopic dermatitis compared to placebo, and most treatment-emergent adverse events were mild or moderate, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of abrocitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies. Schmid-Grendelmeier, P., Gooderham, MJ., Hartmann, K., et al.[2023]

In a phase 2b study involving 267 adults with moderate-to-severe atopic dermatitis, abrocitinib (200 mg and 100 mg) showed significant improvements in symptoms and quality of life compared to placebo, with effects observed as early as 2 days after starting treatment.

Patients reported rapid and lasting relief from itching and other symptoms, with notable improvements in various patient-reported outcome measures, indicating that abrocitinib could be an effective treatment option for those inadequately controlled by current therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptoms and Disease Impacts in Adults With Moderate-to-Severe Atopic Dermatitis: Results From a Phase 2b Study With Abrocitinib. Simpson, EL., Wollenberg, A., Bissonnette, R., et al.[2022]

Daily administration of sunitinib in mice effectively prevented oral antigen-induced anaphylaxis, reducing symptoms like diarrhea and hypothermia, and decreasing mast cell activation and numbers in intestinal tissue.

Sunitinib also showed potential in alleviating systemic anaphylaxis by inhibiting mast cell degranulation and growth, suggesting it could be a promising treatment for food allergies and anaphylactic reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tyrosine kinase inhibitor sunitinib relieves systemic and oral antigen-induced anaphylaxes in mice. Yamaki, K., Yoshino, S.[2018]

In a trial involving 10 adults with peanut allergies, the BTK inhibitor acalabrutinib significantly increased the median tolerated dose of peanut protein from 29 mg to 4,044 mg, demonstrating its potential efficacy in preventing allergic reactions.

The treatment was generally safe, with only 4 transient and nonserious adverse events reported, indicating that acalabrutinib could be a promising option for managing peanut allergies, warranting further larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis. Suresh, RV., Dunnam, C., Vaidya, D., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37988255/

Efficacy and safety of abrocitinib in patients with moderate- ... Results: Of 942 patients, 498 (53%) reported at least one allergic comorbidity (asthma only, 33%; conjunctivitis only or rhinitis only or both, 17%; food ...

2. cibinqo.com cibinqo.com/study-results

Study Results for CIBINQO® (abrocitinib) | Safety Info Clinical studies showed that with CIBINQO, clearer skin and fast itch relief could be achieved. Take a look at the results below.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/all.16512

Integrated Efficacy and Safety Analysis of Abrocitinib in ... Abrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD).

4. va.gov va.gov/formularyadvisor/DOC_PDF/MON_Abrocitinib_CIBINQO_in_Atopic_Dermatitis_Monograph_Feb_2023.pdf

Abrocitinib (CIBINQO) in Atopic Dermatitis National Drug ... Food Allergy 14.9%. Prior topical agents only 56.5%. Prior systemic agents ... Table 3 Absolute Effects for Achieving Selected Efficacy Outcomes for ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03720470

NCT03720470 | Study Evaluating Efficacy and Safety of PF ... Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03349060

NCT03349060 | Study to Evaluate Efficacy and Safety of ... The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12550080/

Do Allergic Comorbidities Alter the Efficacy and Safety of ... Impact of self-reported comorbid food allergy on efficacy and safety of abrocitinib and dupilumab in patients with moderate-to-severe atopic ...