Could a drug make milk allergy therapy safer and more effective?
NCT ID NCT04148352
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding dupilumab (a drug that reduces allergic reactions) to milk oral immunotherapy (gradually eating small amounts of milk) helps people with cow's milk allergy tolerate more milk with fewer side effects. The trial included 33 people aged 4 to 50 years. The study was stopped early, so results are limited, but the goal was to see if the combination allowed participants to safely consume at least 2040 mg of milk protein.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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33 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 4 to 50 years (inclusive) * Clinical history of allergy to cow's milk or milk-containing foods * 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 * Experience clinical reaction at or before 444 mg cumulative protein dose of cow's milk protein on Screening DBPCFC * No clinical reaction observed during the placebo (oat) Screening DBPCFC * 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 * Use of effective birth control by female participants of childbearing potential Exclusion Criteria: * Any previous exposure to dupilumab * Known hypersensitivity to dupilumab or any of its excipients * Known hypersensitivity to epinephrine or any of its excipients * Allergy to oat (placebo in DBPCFC) * History of severe anaphylaxis to cow's milk, defined as neurological compromise or requiring intubation * Recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year * Inability to tolerate biological (antibody) therapies * Body weight \<5 kg at the time of screening * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * History of a mast cell disorder * Established diagnosis of a primary immunodeficiency disorder * Severe asthma or mild or moderate asthma if uncontrolled or difficult to control * Current participation or within the last 4 months in any other interventional study * Use of medication such as beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers * Pregnant or breastfeeding women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic
Scottsdale, Arizona, 85259, United States
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Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
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Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304, United States
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Other studies related to the condition(s) this trial covers.
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