Clinical trial NCT04148352: Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allergies Food Milk
Keywords: Food allergy
Milk allergy
Oral Immunotherapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Robert Levin Charitable Fund
name: Regeneron Pharmaceuticals
First posted: 2019-11-01
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: dupilumab or placebo arm
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Week 18
Secondary outcomes:
measure: Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 18 DBPCFC
timeFrame: Week 18
measure: Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC
timeFrame: Week 18
measure: Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 24 DBPCFC
timeFrame: week 24
measure: Proportion of participants who tolerate at least 2040 mg cumulative milk protein at week 24 DBPCFC
timeFrame: Week 24
measure: Proportion of participants who tolerate 4040 mg cumulative milk protein at week 24 DBPCFC
timeFrame: Week 24
measure: 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
timeFrame: Baseline and week 18
measure: 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
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Palo Alto
country: United States
facility: Sean N. Parker Center for Allergy & Asthma Research at Stanford University
state: California
Study officials:
affiliation: Stanford, Sean N. Parker Center for Allergy & Asthma Research
name: Andrew Long, PharmD
role: STUDY_DIRECTOR
References: