Allergies Food MilkPhase 2NCT04148352
Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
A Phase 2 study testing Dupilumab in people with Allergies Food Milk, run by Andrew J Long, PharmD at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 50 years
- Conditions the study is for
- Allergies Food Milk
- What is being tested?
- Dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Oct 2021to 25 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab and Milk Oral Immunotherapy for the Treatment of Patients With Cow's Milk Allergy
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
- Allergies Food Milk
- Being tested
- Dupilumab, Placebo
- Keywords
- Food allergy, Milk allergy, Oral Immunotherapy
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Dupilumab injected every 2 weeks for 18 weeks
PlaceboOther
Placebo injected every 2 weeks for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | 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 Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 18
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start18 Oct 2021
- Primary completion17 Dec 2024
- Study completion25 Feb 2025
Why it stopped: Resources not available to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergies Food MilkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dupilumab or placebo arm
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew J Long, PharmD
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Levin Charitable Fund, Regeneron Pharmaceuticals
- Responsible party
- Sponsor-investigator, Andrew J Long, PharmD, Stanford University
- Investigators
- Andrew Long, PharmD, Study director, Stanford, Sean N. Parker Center for Allergy & Asthma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148352
- Sponsor's protocol ID
- IRB-52976
- Status last verified
- Dec 2025
- First submitted
- 30 Oct 2019
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
PubMed 38814736
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab and Milk Oral Immunotherapy for the Treatment of Patients With Cow's Milk Allergy
- ClinicalTrials.gov ID
- NCT04148352
- Acronym / sponsor ID
- IRB-52976
- Conditions
- Allergies Food Milk
- Keywords
- Food allergy, Milk allergy, Oral Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resources not available to continue study
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Andrew J Long, PharmDUniversity, hospital or other
- Collaborators
- Robert Levin Charitable Fund, Regeneron Pharmaceuticals
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- dupilumab or placebo arm
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: Dupilumab24-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 |
| Placebo | Placebo comparator | Other: Placebo24-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 may qualify
- Ages
- 4 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabDupilumab injected every 2 weeks for 18 weeks | Drug | Dupilumab |
| PlaceboPlacebo injected every 2 weeks for 18 weeks | Other | Placebo |
Primary outcome
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
Time frame: Week 18
DBPCFC double-blind, placebo-controlled food challenge; OIT oral immunotherapy; withdrawals are imputed as failures
7 secondary outcomes
Proportion of Participants Who Tolerate at Least 1040 mg Cumulative Milk Protein at Week 18 DBPCFC
Time frame: Week 18
Proportion of Participants Who Tolerate 4040 mg Cumulative Milk Protein at Week 18 DBPCFC
Time frame: Week 18
Proportion of Participants Who Tolerate at Least 1040 mg Cumulative Milk Protein at Week 24 DBPCFC
Time frame: week 24
Proportion of Participants Who Tolerate at Least 2040 mg Cumulative Milk Protein at Week 24 DBPCFC
Time frame: Week 24
Proportion of Participants Who Tolerate 4040 mg Cumulative Milk Protein at Week 24 DBPCFC
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
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
Time frame: Baseline and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38814736Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Long, PharmD study director
Stanford, Sean N. Parker Center for Allergy & Asthma Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Allergies Food Milk, run by Andrew J Long, PharmD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04148352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.