TerminatedNCT04148352Updated Jan 7, 2026Results posted

Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy

A Phase 2 interventional study of Dupilumab and Placebo in Allergies Food Milk, sponsored by Andrew J Long, PharmD. Terminated at 3 sites in United States. Open to participants aged 4 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Andrew J Long, PharmD · Phase 2, Interventional, and Treatment

Why this study was terminated

Resources not available to continue study

Phase: Phase 2
Study type: Interventional
Enrollment: 33
Allocation: Randomized
Ages: 4 Years to 50 Years
Sex: All

Study summary

This is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in approximately 40 subjects aged 4 to 50 years, inclusive, who are allergic to cow's milk. 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 rates of desensitization, defined as an increase in the proportion of subjects who pass a double-blind placebo-controlled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.

Conditions studied

Allergies Food Milk

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Keywords

Food allergy
Milk allergy
Oral Immunotherapy

In context

Milk Hypersensitivity

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's enrollment of 33 is below the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

This is the only study on the registry with Andrew J Long, PharmD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by female participants of

Exclusion criteria

Exclusion Criteria:

Any previous exposure to dupilumab
Known to dupilumab or any of its
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

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 33 participants (actual)

Study arms

Experimental
Dupilumab
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
Drug: Dupilumab
Placebo comparator
Placebo
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
Other: Placebo

Interventions

DrugDupilumab
Dupilumab injected every 2 weeks for 18 weeks
OtherPlacebo
Placebo injected every 2 weeks for 18 weeks

What researchers measure

Primary outcomes

Proportion of Participants 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
DBPCFC double-blind, placebo-controlled food challenge; OIT oral immunotherapy; withdrawals are imputed as failures
Time frame: Week 18

Secondary outcomes

Proportion of Participants Who Tolerate at Least 1040 mg Cumulative Milk Protein at Week 18 DBPCFC
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
Time frame: Week 18
Proportion of Participants Who Tolerate 4040 mg Cumulative Milk Protein at Week 18 DBPCFC
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
Time frame: Week 18
Proportion of Participants Who Tolerate at Least 1040 mg Cumulative Milk Protein at Week 24 DBPCFC
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
Time frame: week 24
Proportion of Participants Who Tolerate at Least 2040 mg Cumulative Milk Protein at Week 24 DBPCFC
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
Time frame: Week 24
Proportion of Participants Who Tolerate 4040 mg Cumulative Milk Protein at Week 24 DBPCFC
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
Time frame: Week 24
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
Baseline values reflect the log10 of cumulative tolerated dose (CTD) of milk protein. The change metric reflects the order of magnitude of paired differences in CTD between baseline and week 18.
Time frame: Baseline and week 18
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
Baseline values reflect the log10 of cumulative tolerated dose (CTD) of milk protein. The change metric reflects the order of magnitude of paired differences in CTD between baseline and week 24.
Time frame: Baseline and week 24

Results

Posted Jan 7, 2026

Limitations and caveats

Study findings are limited by the small sample size and high attrition. Screen failures and early loss to follow-up reduced power and may limit the ability to draw definitive conclusions about the intervention's effect.

Participant flow

Participant flow — Overall Study
Milestone	Active Dupilumab and Milk Oral Immunotherapy (OIT)	Placebo for Dupilumab and Milk OIT
Started	11	12
Week 18 double-blind, placebo-controlled food challenge (dbpcfc)	11	8
Week 24 dbpcfc	11	6
Completed	11	6
Not completed	0	6

Outcome measures

PrimaryProportion of Participants 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

DBPCFC double-blind, placebo-controlled food challenge; OIT oral immunotherapy; withdrawals are imputed as failures

Time frame:: Week 18
Reported as:: Count of participants · Participants

Proportion of Participants 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
Participants	Active Dupilumab and Milk OIT	Placebo for Dupilumab and Milk OIT
Proportion of Participants 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	8	5

SecondaryProportion of Participants Who Tolerate at Least 1040 mg Cumulative Milk Protein at Week 18 DBPCFC