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

NCT04148352 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-01-07

Study results available
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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.

Conditions

  • Allergies Food Milk

Interventions

DRUG

Dupilumab

Dupilumab injected every 2 weeks for 18 weeks

OTHER

Placebo

Placebo injected every 2 weeks for 18 weeks

Sponsors & Collaborators

  • Robert Levin Charitable Fund

    collaborator UNKNOWN

  • Regeneron Pharmaceuticals

    collaborator INDUSTRY

  • Andrew J Long, PharmD

    lead OTHER

Principal Investigators

  • Andrew Long, PharmD · Stanford, Sean N. Parker Center for Allergy & Asthma Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-18
Primary Completion
2024-12-17
Completion
2025-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148352 on ClinicalTrials.gov