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

Primary Purpose

Allergies Food Milk

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Dupilumab

Placebo

About this trial

This is an interventional treatment trial for Allergies Food Milk focused on measuring Food allergy, Milk allergy, Oral Immunotherapy

Eligibility Criteria

4 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 ≤17 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

Sites / Locations

Phoenix Children's HospitalRecruiting
Mayo ClinicRecruiting
Sean N. Parker Center for Allergy & Asthma Research at Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dupilumab

Placebo

Arm Description

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

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

Outcomes

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

DBPCFC is a double-blind, placebo-controlled food challenge

Secondary Outcome Measures

Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 18 DBPCFC

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC

Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 24 DBPCFC

Proportion of participants who tolerate at least 2040 mg cumulative milk protein at week 24 DBPCFC

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 24 DBPCFC

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

Full Information

NCT ID

NCT04148352

First Posted

October 30, 2019

Last Updated

October 2, 2023

Sponsor

Andrew J Long, PharmD

Collaborators

Robert Levin Charitable Fund, Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04148352

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

October 2026 (Anticipated)

Study Completion Date

November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew J Long, PharmD

Collaborators

Robert Levin Charitable Fund, Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergies Food Milk

Keywords

Food allergy, Milk allergy, Oral Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

dupilumab or placebo arm

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dupilumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dupilumab

Intervention Description

Dupilumab injected every 2 weeks for 18 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo injected every 2 weeks for 18 weeks

Primary Outcome Measure Information:

Title

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

Description

DBPCFC is a double-blind, placebo-controlled food challenge

Time Frame

Week 18

Secondary Outcome Measure Information:

Title

Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 18 DBPCFC

Time Frame

Week 18

Title

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC

Time Frame

Week 18

Title

Proportion of participants who tolerate at least 1040 mg cumulative milk protein at week 24 DBPCFC

Time Frame

week 24

Title

Proportion of participants who tolerate at least 2040 mg cumulative milk protein at week 24 DBPCFC

Time Frame

Week 24

Title

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 24 DBPCFC

Time Frame

Week 24

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Long, PharmD

Phone

650-521-7237

snpcenterallergy_scheduler@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Long, PharmD

Organizational Affiliation

Stanford, Sean N. Parker Center for Allergy & Asthma Research

Official's Role

Study Director

Facility Information:

Facility Name

Phoenix Children's Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benjamin Wright, MD

Phone

480-301-4284

wright.benjamin@mayo.edu

Facility Name

Mayo Clinic

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Benjamin Wright, MD

Phone

480-301-4284

wright.benjamin@mayo.edu

Facility Name

Sean N. Parker Center for Allergy & Asthma Research at Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sayantani Sindher, MD

Phone

650-521-7237

snpcenterallergy_scheduler@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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