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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 belowSelect...
I am between 4 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
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
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.
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.
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Who is running the clinical trial?
Andrew J Long, PharmDLead Sponsor
Robert Levin Charitable FundUNKNOWN
Regeneron PharmaceuticalsIndustry Sponsor
637 Previous Clinical Trials
382,325 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You are allergic to epinephrine or any of the ingredients in it.You have a history of being allergic to cow's milk or foods that contain milk.You have experienced a very severe allergic reaction to cow's milk that caused serious problems with your breathing or required a tube to help you breathe.I have had issues like severe acid reflux, trouble swallowing, or unexplained stomach problems.My body weight is 5 kg or less at screening.I cannot tolerate treatments that involve antibodies.You have had three or more severe allergic reactions within the past year.I have been diagnosed with a primary immunodeficiency disorder.I am between 4 and 50 years old.I have heart problems or high blood pressure that is not well controlled.You are allergic to dupilumab or any of the ingredients in it.I have a history of a mast cell disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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