Dupilumab and Milk OIT for Cow's Milk Allergy

Recruiting at 3 trial locations

Overseen By Andrew Long, PharmD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrew J Long, PharmD

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using dupilumab with milk oral immunotherapy (OIT) can help people aged 4 to 50 who are allergic to cow's milk. Dupilumab reduces allergic reactions, and OIT helps the body get used to milk. The goal is to see if this combination makes it safer and more effective for these individuals to consume milk. Dupilumab has been approved for treating certain skin conditions and has shown promise in other allergic conditions.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications like beta-blockers, ACE inhibitors, ARBs, or calcium channel blockers. If you are taking these, you may need to stop them to participate.

What data supports the effectiveness of the drug Dupilumab for treating cow's milk allergy?

Dupilumab has been shown to be effective in treating other conditions like atopic dermatitis and asthma by blocking certain proteins involved in inflammation, suggesting it might help with cow's milk allergy by reducing similar inflammatory responses. ^{1 2 3 4 5}

Is dupilumab generally safe for humans?

Dupilumab is generally considered safe for humans, but it has been associated with some eye-related side effects, such as conjunctivitis (eye inflammation), in patients treated for atopic dermatitis. ^{1 6 7 8 9}

How is the treatment of Dupilumab and Milk OIT for cow's milk allergy different from other treatments?

This treatment combines Dupilumab, a drug that targets specific immune responses, with Milk Oral Immunotherapy (OIT), which gradually introduces milk to build tolerance. This combination is unique because it may enhance the safety and effectiveness of OIT, offering a novel approach compared to traditional methods that focus solely on allergen avoidance. ^{10 11 12 13 14}

Research Team

Andrew Long, PharmD

Principal Investigator

Stanford, Sean N. Parker Center for Allergy & Asthma Research

Eligibility Criteria

This trial is for people aged 4 to 50 with a confirmed cow's milk allergy, demonstrated by specific tests. Participants must have reacted to a small amount of milk protein during screening and not be allergic to oats (used in placebo). They should not have cardiovascular disease, severe allergies or asthma, certain immune disorders, or be on conflicting medications. Women who can bear children must use birth control.

Inclusion Criteria

Serum IgE to milk of >4 kUA/L within the last 12 months and/or a SPT to milk ≥6 mm compared to a negative control

Subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study

You have a history of being allergic to cow's milk or foods that contain milk.

Exclusion Criteria

I am taking medication for blood pressure or heart conditions.

I have severe asthma or my asthma is hard to control.

I have been treated with dupilumab before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

4-week run-in period with either dupilumab or placebo

4 weeks

Treatment

12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein OIT

12 weeks

OIT Dosing

8 weeks of milk OIT dosing with no dupilumab or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dupilumab
• Placebo

Trial Overview The study is testing if Dupilumab helps make Milk Oral Immunotherapy (OIT) safer and more effective compared to a placebo. It aims to see if more subjects can tolerate higher amounts of milk protein without allergic reactions after treatment.

Participant Groups

Group I: Dupilumab Experimental Treatment 1 Intervention

24-week treatment period, which includes a 4-week run-in period with dupilumab followed by 12 weeks of treatment with dupilumab in combination with a gradual up-dosing of milk protein OIT, then followed by 8 weeks of milk OIT dosing with no dupilumab

Group II: Placebo Placebo Group 1 Intervention

24-week treatment period, which includes a 4-week run-in period with placebo for dupilumab followed by 12 weeks of treatment with placebo for dupilumab in combination with a gradual up-dosing of milk protein OIT, then followed by 8 weeks of milk OIT dosing with no placebo

Who Is Running the Clinical Trial?

Andrew J Long, PharmD

Lead Sponsor

Trials

1

Recruited

30+

Robert Levin Charitable Fund

Collaborator

Trials

1

Recruited

30+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Findings from Research

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

Dupilumab is an effective treatment for atopic dermatitis, showing significant improvements in skin symptoms and overall disease control in clinical trials.

The medication works by inhibiting specific pathways in the immune system, which helps reduce inflammation and alleviate the symptoms of atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. D'Ippolito, D., Pisano, M.[2020]

Dupilumab, a monoclonal antibody that blocks IL-4 and IL-13 signaling, has been shown to significantly improve asthma symptoms and reduce exacerbation rates in adolescents and adults, based on Phase II and III clinical trials.

The treatment has a favorable safety profile and has also been approved for use in atopic dermatitis, highlighting its effectiveness across multiple atopic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in the treatment of asthma. Grey, A., Katelaris, CH.[2020]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupilumab (Dupixent) has been associated with a risk of ocular adverse reactions, highlighting the importance of monitoring patients for eye-related side effects during treatment.

Prompt management of any ocular issues is essential for patients receiving dupilumab, ensuring their safety and well-being while benefiting from the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Dupilumab (Dupixent): An Interleukin-4 Receptor Antagonist for Atopic Dermatitis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Dupilumab in the treatment of asthma. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety update: dupilumab and ocular adverse reactions. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Assessment of potential predictive factors of dupilumab response in patients with moderate-to-severe atopic dermatitis. [2023]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

Real-life experience in the effectiveness, impact on quality of life and safety of dupilumab treatment in patients with moderate to severe atopic dermatitis in the Czech Republic. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Risk Factors for Dupilumab-Associated Conjunctivitis in Patients With Atopic Dermatitis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Mechanistic correlates of clinical responses to omalizumab in the setting of oral immunotherapy for milk allergy. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Use of IgE and IgG4 epitope binding to predict the outcome of oral immunotherapy in cow's milk allergy. [2022]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for food allergy: towards a new horizon. [2021]

14. Norway pubmed.ncbi.nlm.nih.gov

Elevated serum adipsin may predict unsuccessful treatment for cows' milk allergy but other biomarkers do not. [2020]