What side effects are associated with this type of intervention?

Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is being studied as an adjunct to milk oral immunotherapy (OIT) for cow's milk allergy. Common side effects of dupilumab include conjunctivitis, nasopharyngitis, and injection site reactions. Additionally, facial redness and an increased risk of Th17-driven diseases such as seronegative arthritis, psoriasis, and enthesitis have been reported. These side effects are important considerations for patients undergoing treatment for food allergies, including milk allergy.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for food allergies to milk mentioned in the provided context. However, dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is being studied as an adjunct to milk oral immunotherapy (OIT) to improve safety and desensitization rates. Other monoclonal antibodies, such as omalizumab, have been studied in combination with OIT for various food allergies, including milk, but specific FDA approvals for these treatments are not detailed.

What other types of research exist?

Promising alternatives to Dupilumab for treating food allergies, including milk allergy, include anti-IgE therapies such as omalizumab and ligelizumab. These therapies have shown efficacy in clinical trials for various food allergies. Additionally, the use of probiotics and CpG-coated nanoparticles as adjuvants in oral immunotherapy (OIT) are novel approaches being explored for their potential to improve desensitization and safety in food allergy treatments.

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Dupilumab and Milk OIT for Cow's Milk Allergy

Phase 2

Recruiting

Research Sponsored by Andrew J Long, PharmD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 4 to 50 years (inclusive)

Be younger than 65 years old

Must not have

Severe asthma or mild or moderate asthma if uncontrolled or difficult to control

Any previous exposure to dupilumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dupilumab may cause injection site reactions, eye issues like redness or itching, cold sores in the mouth or throat area, and inflammation of blood vessels. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been treated with dupilumab before.

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I have had issues like severe acid reflux, trouble swallowing, or unexplained stomach problems.

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My body weight is 5 kg or less at screening.

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I cannot tolerate treatments that involve antibodies.

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I have been diagnosed with a primary immunodeficiency disorder.

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I have heart problems or high blood pressure that is not well controlled.

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I have a history of a mast cell disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects treated with dupilumab plus milk protein OIT vs placebo plus milk protein OIT who tolerate at least 2040 mg (cumulative) cow's milk protein during DBPCFC to milk at week 18

Secondary outcome measures

Change in the cumulative tolerated dose (CTD) of milk protein during DBPCFC from baseline to week 18 across cohorts as pairwise comparisons of all treatment groups

Change in the cumulative tolerated dose (CTD) of milk protein during DBPCFC from baseline to week 24 across cohorts as pairwise comparisons of all treatment groups

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC

+4 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 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: PlaceboPlacebo Group1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for food allergy to milk include oral immunotherapy (OIT) and monoclonal antibodies like Dupilumab. OIT works by gradually increasing the amount of milk protein ingested to build tolerance. Dupilumab, a monoclonal antibody, inhibits IL-4 and IL-13 signaling, which are key drivers of allergic inflammation. This inhibition can reduce the immune system's overreaction to milk proteins, potentially improving safety and efficacy of OIT. Understanding these mechanisms is crucial for patients as it highlights how these treatments can help manage and potentially desensitize their milk allergy, improving their quality of life.

Acral erythema arising in patients with atopic dermatitis after dupilumab therapy: A case report of 3 patients.Efficacy of Dupilumab in a Phase 2 Randomized Trial of Adults With Active Eosinophilic Esophagitis.Dupilumab treatment in moderate-to-severe atopic dermatitis: A systematic review and meta-analysis.