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Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
Phase 2 trial testing Dupilumab in Allergies Food Milk in 33 participants. Terminated before completion.
| Lead sponsor | Andrew J Long, PharmD |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 18 October 2021 |
| Primary completion | 17 December 2024 |
| Estimated completion | 25 February 2025 |
| Sites | 3 locations across United States |
Andrew J Long, PharmD
Adults 4 to 50, any sex, with Allergies Food Milk. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DBPCFC double-blind, placebo-controlled food challenge; OIT oral immunotherapy; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 8 | |
| Placebo for Dupilumab and Milk OIT | 5 |
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 9 | |
| Placebo for Dupilumab and Milk OIT | 6 |
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 5 | |
| Placebo for Dupilumab and Milk OIT | 3 |
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 8 | |
| Placebo for Dupilumab and Milk OIT | 5 |
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 7 | |
| Placebo for Dupilumab and Milk OIT | 5 |
DBPCFC double-blind, placebo-controlled food challenge; withdrawals are imputed as failures
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 5 | |
| Placebo for Dupilumab and Milk OIT | 3 |
Baseline values reflect the log10 of cumulative tolerated dose (CTD) of milk protein. The change metric reflects the order of magnitude of paired differences in CTD between baseline and week 18.
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 1.632 | ± 0.888 |
| Placebo for Dupilumab and Milk OIT | 1.899 | ± 0.600 |
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 1.574 | ± 0.880 |
| Placebo for Dupilumab and Milk OIT | 1.127 | ± 0.618 |
Baseline values reflect the log10 of cumulative tolerated dose (CTD) of milk protein. The change metric reflects the order of magnitude of paired differences in CTD between baseline and week 24.
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 1.632 | ± 0.888 |
| Placebo for Dupilumab and Milk OIT | 1.898 | ± 0.691 |
| Group | Value | 95% CI |
|---|---|---|
| Active Dupilumab and Milk OIT | 1.559 | ± 1.153 |
| Placebo for Dupilumab and Milk OIT | 1.366 | ± 0.490 |
Time frame: From enrollment until end of follow-up, up to 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Active Dupilumab and Milk … | Placebo for Dupilumab and … |
|---|---|---|---|
| Gastrointestinal Allergic AEs related to OIT | Gastrointestinal disorders | — | — |
| Respiratory Allergic AEs related to OIT | Respiratory, thoracic and mediastinal disorders | — | — |
| Skin Allergic AEs related to OIT | Skin and subcutaneous tissue disorders | — | — |
| Skin Food Challenge Reactions Allergic not related to OIT | Skin and subcutaneous tissue disorders | — | — |
| Gastrointestinal Food Challenge Reactions Allergic not related to OIT | Gastrointestinal disorders | — | — |
| Respiratory Food Challenge Reactions Allergic not related to OIT | Respiratory, thoracic and mediastinal disorders | — | — |
| General Allergic AEs related to OIT | General disorders | — | — |
| General/administration site Non-Allergic not related to OIT | General disorders | — | — |
| Infection Non-Allergic not related to OIT | Infections and infestations | — | — |
| Respiratory Non-Allergic not related to OIT | Respiratory, thoracic and mediastinal disorders | — | — |
| Nervous System Food Challenge Reactions Allergic not related to OIT | Nervous system disorders | — | — |
| Nervous Non-Allergic not related to OIT | Nervous system disorders | — | — |
| Eye Allergic AEs related to OIT | Eye disorders | — | — |
| Immune system Allergic AEs related to OIT | Immune system disorders | — | — |
| Psychiatric Food Challenge Reactions Allergic not related to OIT | Psychiatric disorders | — | — |
| Immune System Food Challenge Reactions Allergic not related to OIT | Immune system disorders | — | — |
| Gastrointestinal Non-Allergic not related to OIT | Gastrointestinal disorders | — | — |
| Skin Non-Allergic not related to OIT | Skin and subcutaneous tissue disorders | — | — |
| Nervous system Allergic AEs related to OIT | Nervous system disorders | — | — |
| Vascular Allergic AEs related to OIT | Vascular disorders | — | — |
| Eye Food Challenge Reactions Allergic not related to OIT | Eye disorders | — | — |
| Eye Non-Allergic not related to OIT | Eye disorders | — | — |
| Renal/Urinary Non-Allergic not related to OIT | Renal and urinary disorders | — | — |
| Injury Non-Allergic not related to OIT | Injury, poisoning and procedural complications | — | — |
| Ear Non-Allergic not related to OIT | Ear and labyrinth disorders | — | — |
Data from ClinicalTrials.gov NCT04148352 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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