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Dupilumab and Milk OIT for Cow's Milk Allergy

Phase 2

Recruiting

Research Sponsored by Andrew J Long, PharmD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 4 to 50 years (inclusive)

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial is testing whether dupilumab can improve the safety of milk oral immunotherapy and rates of desensitization in people with cow's milk allergies.

Who is the study for?

This trial is for people aged 4 to 50 with a confirmed cow's milk allergy, demonstrated by specific tests. Participants must have reacted to a small amount of milk protein during screening and not be allergic to oats (used in placebo). They should not have cardiovascular disease, severe allergies or asthma, certain immune disorders, or be on conflicting medications. Women who can bear children must use birth control.Check my eligibility

What is being tested?

The study is testing if Dupilumab helps make Milk Oral Immunotherapy (OIT) safer and more effective compared to a placebo. It aims to see if more subjects can tolerate higher amounts of milk protein without allergic reactions after treatment.See study design

What are the potential side effects?

Dupilumab may cause injection site reactions, eye issues like redness or itching, cold sores in the mouth or throat area, and inflammation of blood vessels. Not everyone will experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 4 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects 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

Secondary outcome measures

Change in the cumulative tolerated dose (CTD) of milk protein during DBPCFC from baseline to week 18 across cohorts as pairwise comparisons of all treatment groups

Change in the cumulative tolerated dose (CTD) of milk protein during DBPCFC from baseline to week 24 across cohorts as pairwise comparisons of all treatment groups

Proportion of participants who tolerate 4040 mg cumulative milk protein at week 18 DBPCFC

+4 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

OLE Period: Placebo/Dupilumab

DB Period: Dupilumab

OLE Period: Dupilumab/Dupilumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~12230

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Andrew J Long, PharmDLead Sponsor

Robert Levin Charitable FundUNKNOWN

Regeneron PharmaceuticalsIndustry Sponsor

620 Previous Clinical Trials

380,269 Total Patients Enrolled

Media Library

Dupilumab Clinical Trial Eligibility Overview. Trial Name: NCT04148352 — Phase 2

Food Allergy to Milk Research Study Groups: Dupilumab, Placebo

Food Allergy to Milk Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04148352 — Phase 2

Dupilumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04148352 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What makes this clinical trial unique?

"Dupilumab was first trialled in 2015 by the pharmaceutical company Sanofi. The initial study had 880 participants. After Phase 3 approval, Dupilumab's clinical trials expanded to 51 studies conducted in 446 cities and 43 different countries."

Answered by AI

How many patients are in this clinical trial?

"That is correct. The clinicaltrials.gov website contains information revealing that this trial is currently recruiting patients. This study was first posted on October 18th, 2021 and has since been edited on October 31st, 2022. A total of 116 individuals are needed from 3 different locations to participate in this research project."

Answered by AI

Are there any vacancies for patients in this experiment?

"Yes, the trial is currently ongoing. According to information found on clinicaltrials.gov, which was last updated on 10/31/2022, the study began enrolling patients on 10/18/2021. A total of 116 individuals are being recruited from 3 hospitals."

Answered by AI

What medical conditions has Dupilumab been most commonly associated with treating?

"Dupilumab is a medication that is often used to help patients with dermatitis, atopic eczema. Additionally, it can be useful for treating other conditions like asthma and eosinophil."

Answered by AI

What other research studies have included Dupilumab as a treatment?

"Dupilumab was first trialled in 2015 at the Regeneron Investigational Site. In the 5 years since, there have been a total of 18322 completed trials worldwide. As of now, 51 studies are still active, with several taking place in Scottsdale, California."

Answered by AI

Does this research allow for elderly participation?

"Eligibility for this trial is restricted to children aged 4 to 50. Out of the 400 total studies, 104 are for patients younger than 18 and 200 are for those over 65."

Answered by AI

How can I get involved in this research?

"This study is currently looking for 116 individuals between the ages of 4 and 50 who have an allergy to milk or food. The most notable requirement for participants is that they fall within the age bracket of 4 to 50 years old."

Answered by AI

What is the long-term safety profile of Dupilumab?

"Dupilumab's safety was scored a 2 by our team because, while there is some evidence backing its safety profile, Dupilumab has not been proven effective in clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Andrew J Long, PharmD 2021. "Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04148352.

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