Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Andrew J Long, PharmD
Collaborators:
Regeneron Pharmaceuticals Robert Levin Charitable Fund