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Monoclonal Antibodies

Dupilumab for Asthma

Phase 4
Waitlist Available
Led By Yvonne Huang, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 4 months
Awards & highlights

Study Summary

This trial is investigating whether the study drug, dupilumab, can improve the health of participants lungs, boost immune response, as well as improve quality of life for people with severe asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in beta-diversity of respiratory microbiota
Change in beta-diversity of stool microbiota
Change in relative abundances of microbiota members
+3 more
Secondary outcome measures
Asthma Control Test (ACT)
Change in Fractional exhaled nitric oxide (FeNO)
Adrenal Cortex Hormones
+5 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367
9%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: DupilumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,901 Total Patients Enrolled
17 Trials studying Asthma
5,238 Patients Enrolled for Asthma
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,832 Total Patients Enrolled
28 Trials studying Asthma
11,972 Patients Enrolled for Asthma
Yvonne Huang, MDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

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

What is the aggregate figure of participants in this experiment?

"Affirmative. The details found on clinicaltrials.gov indicate that the trial, which was first launched in February 22nd 2022, is still recruiting participants. There are 15 individuals needed at one research site to be able to take part of this study."

Answered by AI

Does this research endeavor break new ground?

"Presently, there are 49 ongoing studies for Dupilumab spread across 436 cities and 43 countries. The development of this drug began with a Sanofi-sponsored study of 880 participants in 2015; it successfully reached Phase 3 before concluding. In the ensuing years, 54 further examinations have been concluded."

Answered by AI

Is this medical experiment accepting participants at the current time?

"Clinicaltrials.gov confirms that the study, which was initially uploaded on 22nd February 2022, is in search of participants. This listing has been updated as recently as 3rd March 2022."

Answered by AI

Has Dupilumab been tested in prior research studies?

"Currently, 49 studies are actively researching the effects of Dupilumab with 13 trials in their final stages. While most investigations are centered in Palo Alto, California, 2603 different centres worldwide have launched studies for this medication."

Answered by AI

What maladies can be alleviated through the use of Dupilumab?

"Dupilumab is traditionally used to treat dermatitis and atopic allergies. Additionally, it has proven successful in alleviating the symptoms of eosinophilic asthma and corticosteroid therapy resistant failure."

Answered by AI

Has the FDA sanctioned Dupilumab for therapeutic utilization?

"There is extensive clinical evidence in support of Dupilumab's safety, so it has been assigned a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma
Yvonne J Huang 2022. "Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036733.
~5 spots leftby Apr 2025
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