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Clinical trial

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

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Last updated:4th Apr 2021
Status: Not yet recruiting
Identifier: NCT04148352
Dupilumab and Milk OIT for the Treatment of 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.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dupilumab or placebo arm
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date: June 2021
Estimated Primary Completion Date: June 2022
Estimated Study Completion Date: July 2022

- Experimental: Dupilumab
- Placebo Comparator: Placebo

Category Value
Study type(s) Interventional
Estimated enrolment 116
Estimated Study start date 01 June 2021
Estimated Study Completion Date 01 July 2022

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