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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 50 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04148352
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Andrew J Long, PharmD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrew Long, PharmD
Principal Investigator Affiliation	Stanford, Sean N. Parker Center for Allergy & Asthma Research
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergies Food Milk

Arms & Interventions

Arms

Experimental: Dupilumab

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

Placebo Comparator: Placebo

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

Interventions

Drug: - Dupilumab

Dupilumab injected every 2 weeks for 18 weeks

Other: - Placebo

Placebo injected every 2 weeks for 18 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Children's Hospital, Phoenix, Arizona

Status

Recruiting

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Site Contact

Benjamin Wright, MD

[email protected]

480-301-4284

Mayo Clinic, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Site Contact

Benjamin Wright, MD

[email protected]

480-301-4284

Palo Alto, California

Status

Recruiting

Address

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

Palo Alto, California, 94304

Site Contact

Sayantani Sindher, MD

[email protected]

650-521-7237

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