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Monoclonal Antibodies

Dupilumab for Asthma

Q: Is this endeavor unique in its kind?

As of now, Dupilumab has been tested in 49 separate clinical trials located across 436 cities and 43 countries. Sanofi was the first to sponsor a trial for this medication back in 2015 - an 880-patient Phase 3 study that eventually led to drug approval. Since then, 18360 additional studies have concluded their research.

Q: How many participants are being accepted into this medical trial?

Affirmative, information on clinicaltrials.gov states that this study is presently attempting to enlist participants. This experiment was initiated on October 17th 2022 and has had its post updatd as of November 3rd 2022. The trial requires 30 patients from a single location.

Q: Are there any prior experiments that have utilized Dupilumab?

Presently, there are 49 studies that investigate Dupilumab with 13 trials in Phase 3. Though the majority of research is conducted at Palo Alto, <a href="https://www.withpower.com/clinical-trials/california">California</a>; a total of 2602 medical centres around the world have active clinical trials on this medication.

Q: Are there any potential risks associated with the administration of Dupilumab?

The risk profile of Dupilumab is rated as 3 since this Phase 4 clinical trial has been approved, demonstrating its proven safety.

Q: Are recruitment efforts still underway for this research endeavor?

This medical research is actively seeking participants, as per the data hosted on clinicaltrials.gov. The initial posting of this study was October 17th 2022 and it has been amended most recently on November 3rd 2022.

Q: To what maladies has Dupilumab been found to be efficacious?

Dupilumab is typically given to treat dermatitis, atopic. It has also been prescribed as a solution for corticosteroid-resistant cases of eosinophilia and <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>.

Phase 4

Recruiting

Research Sponsored by Sally E. Wenzel MD

Eligibility Criteria Checklist

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

Must have

Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) <90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller

Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from baseline to 12 weeks after start of treatment

Awards & highlights

Study Summary

This trial will test whether the drug dupilumab can improve mucus clearance in asthma patients.

Who is the study for?

Adults over 18 with moderate to severe asthma, who are on high doses of inhaled steroids and have specific markers indicating poor lung function (like low FEV1/FVC or high blood eosinophils). They shouldn't be very overweight, have had certain cancers recently, respiratory infections or used specific asthma drugs lately. Smokers and pregnant women are excluded.Check my eligibility

What is being tested?

The study is testing the effects of Dupilumab versus a placebo on how well the lungs clear mucus in patients with moderate to severe asthma. It's a controlled trial where participants are randomly chosen to receive either Dupilumab or an inactive substance.See study design

What are the potential side effects?

Dupilumab may cause injection site reactions, eye problems like redness and itching, joint pain, and allergic reactions. Some people might experience cold sores or worsening of existing parasitic infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

My asthma is severe, and I'm on a medium to high dose of inhaled steroids.

Select...

I use inhaled steroids, 500mcg or more daily.

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 12 weeks after the start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 12 weeks after the start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 12 weeks after the start of treatment 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 mucociliary clearance (MCC) rate

Secondary outcome measures

Change in ACT score

Change in FEV1% predicted

Change in mucus plugging score by CT

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DupilumabActive Control1 Intervention

Two injections of Dupilumab will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of Dupilumab will be given every 2 weeks ± 3 days at home by the patient. The doses of investigational product must be separated by ≥11 days to avoid an overdose.

Group II: PlaceboPlacebo Group1 Intervention

Two injections of placebo will be administered at Week 0/Visit 3 as a loading dose. Subsequently one injection of placebo will be given every 2 weeks ± 3 days at home by the patient. The doses must be separated by ≥11 day.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sally E. Wenzel MDLead Sponsor

4 Previous Clinical Trials

765 Total Patients Enrolled

4 Trials studying Asthma

765 Patients Enrolled for Asthma

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04743791 — Phase 4

Asthma Research Study Groups: Dupilumab, Placebo

Asthma Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04743791 — Phase 4

Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743791 — Phase 4

Frequently Asked Questions

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

Is this endeavor unique in its kind?

"As of now, Dupilumab has been tested in 49 separate clinical trials located across 436 cities and 43 countries. Sanofi was the first to sponsor a trial for this medication back in 2015 - an 880-patient Phase 3 study that eventually led to drug approval. Since then, 18360 additional studies have concluded their research."

Answered by AI

How many participants are being accepted into this medical trial?

"Affirmative, information on clinicaltrials.gov states that this study is presently attempting to enlist participants. This experiment was initiated on October 17th 2022 and has had its post updatd as of November 3rd 2022. The trial requires 30 patients from a single location."

Answered by AI

Are there any prior experiments that have utilized Dupilumab?

"Presently, there are 49 studies that investigate Dupilumab with 13 trials in Phase 3. Though the majority of research is conducted at Palo Alto, California; a total of 2602 medical centres around the world have active clinical trials on this medication."

Answered by AI

Are there any potential risks associated with the administration of Dupilumab?

"The risk profile of Dupilumab is rated as 3 since this Phase 4 clinical trial has been approved, demonstrating its proven safety."

Answered by AI

Are recruitment efforts still underway for this research endeavor?

"This medical research is actively seeking participants, as per the data hosted on clinicaltrials.gov. The initial posting of this study was October 17th 2022 and it has been amended most recently on November 3rd 2022."

Answered by AI

To what maladies has Dupilumab been found to be efficacious?

"Dupilumab is typically given to treat dermatitis, atopic. It has also been prescribed as a solution for corticosteroid-resistant cases of eosinophilia and asthma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

Sally E. Wenzel MD 2022. "Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04743791.

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