Allergies Food Milk Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 116 |
| Est. completion date | November 2026 |
| Est. primary completion date | October 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 50 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sean N. Parker Center for Allergy & Asthma Research at Stanford University | Palo Alto | California |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Mayo Clinic | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Andrew J Long, PharmD | Regeneron Pharmaceuticals, Robert Levin Charitable Fund |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | DBPCFC is a double-blind, placebo-controlled food challenge | Week 18 | |
| Secondary | Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 18 DBPCFC | Week 18 | ||
| Secondary | Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC | Week 18 | ||
| Secondary | Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 24 DBPCFC | week 24 | ||
| Secondary | Proportion of participants who tolerate at least 2040 mg cumulative milk protein at week 24 DBPCFC | Week 24 | ||
| Secondary | Proportion of participants who tolerate 4040 mg cumulative milk protein at week 24 DBPCFC | Week 24 | ||
| Secondary | 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 and week 18 | ||
| Secondary | 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 and week 24 |