Dupilumab and Milk OIT for Cow's Milk Allergy

No longer recruiting at 3 trial locations

Overseen By Andrew Long, PharmD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrew J Long, PharmD

Must not be taking: Beta-blockers, ACE inhibitors

Disqualifiers: Severe asthma, Cardiovascular disease, Eosinophilic esophagitis, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding dupilumab, a medication, to milk oral immunotherapy (OIT) can help individuals with cow's milk allergies safely increase their milk tolerance. The goal is to determine if more participants can consume a larger amount of milk protein without reacting. Participants will receive either dupilumab or a placebo alongside their milk OIT. Suitable candidates are those who have experienced allergic reactions to cow's milk but not severe anaphylaxis. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in allergy treatment.

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.

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

Research shows that dupilumab, the treatment under study, is generally safe. In studies for other conditions, such as moderate-to-severe atopic dermatitis, dupilumab has been well-tolerated. Although unwanted side effects have been reported, they are uncommon. Some studies noticed a decrease in certain immune markers related to food over time, suggesting the body can handle the treatment well. The FDA has already approved dupilumab for other conditions, indicating a good safety record.

This trial tests dupilumab with milk oral immunotherapy (OIT) to help people with cow's milk allergy. As the trial is in an early stage, safety remains a key focus. Overall, previous studies show that dupilumab is generally safe, but more data from this specific trial will provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Dupilumab in combination with milk oral immunotherapy (OIT) for cow's milk allergy because it offers a novel approach compared to standard treatments like strict avoidance and emergency epinephrine. Dupilumab works by targeting the interleukin-4 receptor alpha (IL-4Rα), which plays a crucial role in the allergic response, potentially reducing the severity of allergic reactions. Combined with milk OIT, which gradually increases tolerance to milk proteins, this treatment could enhance the effectiveness and safety of desensitization efforts. This approach may offer a more proactive and potentially long-lasting solution for managing cow's milk allergy, providing hope for improved quality of life for those affected.

What evidence suggests that dupilumab and milk OIT could be effective for cow's milk allergy?

Research has shown that combining dupilumab with milk oral immunotherapy (OIT) might benefit individuals with cow's milk allergy. In this trial, some participants will receive dupilumab with milk OIT, while others will receive a placebo with milk OIT. Studies have found that dupilumab can enhance the safety and effectiveness of milk OIT. Participants taking dupilumab with milk OIT were more likely to pass a food challenge, allowing them to consume more milk protein without a reaction. Dupilumab is already used to treat skin conditions like atopic dermatitis, suggesting it might also aid in managing allergies. Although more research is needed, early results appear promising for those with milk allergies. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew Long, PharmD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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 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]

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 (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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04148352

Study Details | NCT04148352 | Dupilumab and Milk OIT for ... The primary objective is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves the safety of milk OIT and ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0Mdy0000001C5ZEAU/nct04148352

Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy The primary objective is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves the safety of milk OIT and ...

3. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/d/NCT04148352.html

Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy The primary objective is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves the safety of milk OIT and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK565242/table/cl.app1.tab3/

Clinical Review Report: Dupilumab (Dupixent) - NCBI Bookshelf Indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11254451/

Dupilumab induces a significant decrease of food specific ... Spekhorst et al. reported an overall percentage decrease in food sIgE levels of 53.0%–62.9% after 1 year and 85.3%–86.9% after 3 years of dupilumab treatment.