Dupilumab for Asthma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Sally E. Wenzel MD

Must be taking: Inhaled corticosteroids

Must not be taking: Anti-IL-5 therapies, Dupilumab

Disqualifiers: Pregnancy, Smoking, COPD, Cancer, others

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does require that you are on medium to high dose inhaled corticosteroids. If you are using antibiotics, oral prednisone, or certain asthma medications like dupilumab or anti-IL-5 therapies, you may need to stop those before joining.

What data supports the effectiveness of the drug Dupilumab for asthma?

Dupilumab has been shown to be effective in treating severe type-2 asthma, as it targets specific pathways involved in inflammation. It has also been used successfully for other conditions like atopic dermatitis and chronic rhinitis, suggesting its potential effectiveness in asthma. ^{1 2 3 4 5}

Is Dupilumab generally safe for treating asthma?

Dupilumab is generally considered safe for treating moderate to severe asthma, with minimal adverse events reported. It has been shown to improve lung function and reduce inflammation, and its safety profile is similar to a placebo in most cases. ^{2 3 6 7 8}

What makes the drug Dupilumab unique for treating asthma?

Dupilumab is unique because it targets the IL-4 and IL-13 signaling pathways, which are involved in type 2 inflammation, making it effective for severe asthma that is not well-controlled by standard treatments. It is a monoclonal antibody, which means it is a type of protein designed to specifically target and block these pathways, potentially offering benefits for both eosinophilic and non-eosinophilic severe asthma. ^{1 2 3 4 9}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Your exhaled nitric oxide level is higher than 25 parts per billion.

You have more than 300 eosinophils per cubic millimeter of blood.

My lung function improved by 12% or more recently, or I had a positive asthma test.

Exclusion Criteria

I have not had any cancer other than skin cancer in the past 5 years.

I have not had a respiratory infection in the last 30 days.

You have a very high body mass index (BMI).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dupilumab or placebo for 12 weeks, with injections every 2 weeks

12 weeks

1 visit (in-person) for loading dose, subsequent doses administered at home

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dupilumab (Monoclonal Antibodies)
• Placebo ()

Trial Overview 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.

Participant Groups

Group I: Dupilumab Active Control 1 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: Placebo Placebo Group 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Pittsburgh Asthma Institute at UPMC Pittsburgh, PA

Who Is Running the Clinical Trial?

Sally E. Wenzel MD

Lead Sponsor

Trials

5

Patients Recruited

800+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. Carpagnano, GE., Scioscia, G., Buonamico, E., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of asthma. Santini, G., Mores, N., Malerba, M., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study. Korn, S., Schmidt, O., Timmermann, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. Indolfi, C., Dinardo, G., Klain, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. Touhouche, AT., Cassagne, M., Bérard, E., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. Zaazouee, MS., Alwarraqi, AG., Mohammed, YA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab in the treatment of asthma. Grey, A., Katelaris, CH.[2020]

In a study of 64 patients with severe asthma, dupilumab significantly improved asthma control and lung function after 12 months, as evidenced by a notable increase in asthma control test scores and forced expiratory volume.

Dupilumab also reduced the need for oral steroids and the frequency of asthma exacerbations, although some patients experienced hypereosinophilia, which did not affect the overall clinical response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. Dupin, C., Belhadi, D., Guilleminault, L., et al.[2021]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Early effectiveness of type-2 severe asthma treatment with dupilumab in a real-life setting; a FeNO-driven choice that leads to winning management. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Dupilumab for the treatment of asthma. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study. [2023]

4. Singapore pubmed.ncbi.nlm.nih.gov

Time effect of dupilumab to treat severe uncontrolled asthma in adolescents: A pilot study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for dupilumab associated ocular adverse events: a real-life prospective study. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Dupilumab in the treatment of asthma. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort. [2021]