drugset
drugset / Trial / NCT04148352

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

NCT04148352 ↗

Phase 2 Terminated 33 enrolled Andrew J Long, PharmD Regeneron Pharmaceuticals · collabRobert Levin Charitable Fund · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2021-10-18
Primary completion
2024-12-17
Completion
2025-02-25

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody — Other

Indications

food allergy