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

Conditions

• Allergies Food Milk

Eligibility Criteria

Sex

ALL

Age

4 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Dupilumab injected every 2 weeks for 18 weeks
• Placebo — OTHER
  Placebo injected every 2 weeks for 18 weeks

Study Details

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.

Key Dates

Start date

Oct 18, 2021

Status verified

Dec 2025

Primary completion

Dec 17, 2024

Completion

Feb 25, 2025

Study Design

Enrollment

33 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

Proportion of Participants Treated With Dupilumab Plus Milk Protein OIT vs Placebo Plus Milk Protein OIT Who Tolerate at Least 2040 mg (Cumulative) Cow's Milk Protein During DBPCFC to Milk at Week 18 [ Time Frame: Week 18 ]

Locations (3)

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