Dupilumab for Asthma

Overseen By John Moore

Age: 18+

Sex: Any

Trial Phase: Phase 4

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 This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well dupilumab, an injectable medication, aids in clearing mucus from the lungs in individuals with moderate to severe asthma. Participants will receive either dupilumab or a placebo (an inactive substance) for comparison. The trial is ideal for those with long-standing asthma, who use high doses of inhaled steroids, and whose asthma remains poorly controlled, as indicated by frequent symptoms or attacks. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for these treatments?

Research shows that dupilumab is generally safe for people with asthma. Studies have found that it can cause some side effects, such as upper respiratory tract infections, similar to common colds, and injection site reactions, like redness or swelling. However, these side effects are usually mild and manageable.

People with moderate to severe asthma have used dupilumab in other studies without major problems. The FDA has approved it for other conditions, indicating a good safety record. Overall, most patients tolerate dupilumab well, but like any treatment, it may not be right for everyone. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard asthma treatments, which primarily focus on easing symptoms by targeting inflammation through corticosteroids or bronchodilators, Dupilumab works differently. It’s a monoclonal antibody that specifically targets and blocks the activity of interleukin-4 and interleukin-13, key proteins involved in the inflammatory response in asthma. This unique mechanism could potentially offer a more precise approach to managing asthma, especially for patients whose symptoms are not well-controlled by existing treatments. Researchers are excited about Dupilumab because it represents a shift towards targeting the underlying causes of inflammation rather than just alleviating symptoms.

What is the effectiveness track record for dupilumab in treating asthma?

Research shows that dupilumab, which participants in this trial may receive, helps treat moderate to severe asthma. Studies found that people taking dupilumab experienced fewer asthma attacks than those taking a placebo, a harmless treatment with no active medicine. Dupilumab proved especially helpful for individuals with higher levels of eosinophils, a type of white blood cell that causes inflammation in asthma. It also improved lung function in asthma patients. This treatment is already approved for other conditions, demonstrating its effectiveness and safety. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• 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.

How Is the Trial Designed?

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.

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Sally E. Wenzel MD

Lead Sponsor

Trials

5

Recruited

800+

Published Research Related to This Trial

Dupilumab significantly improved the quality of life for adolescents with uncontrolled severe asthma within just 4 weeks of treatment, with 80% of participants able to reduce their inhaled corticosteroid dosage.

Throughout the 24-week study, none of the five adolescents experienced asthma exacerbations, indicating that dupilumab effectively controlled their asthma symptoms.

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]

Dupilumab is a monoclonal antibody that targets the IL-4 receptor, blocking signals from IL-4 and IL-13, and is currently in phase III trials for treating moderate-to-severe asthma, showing promise for both eosinophilic and non-eosinophilic asthma phenotypes.

While dupilumab appears to be generally well tolerated, further large-scale studies are necessary to fully evaluate its long-term safety and efficacy, especially in pediatric populations where data is currently lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 99 patients with severe asthma, the majority exhibited diverse clinical characteristics, with 58% having adult-onset asthma and 48% showing an allergic phenotype, indicating a range of profiles among those eligible for dupilumab treatment.

The analysis revealed that 70% of patients met at least one GINA criterion for type 2 airway inflammation, and 64% had comorbidities associated with type 2 inflammation, highlighting the complexity of managing severe asthma in real-world settings.

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]

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume and asthma control questionnaire scores over 12 and 24 weeks in 13 trials.

The treatment is generally safe, showing no significant increase in adverse events compared to placebo, although it was associated with higher blood eosinophil levels.

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]

In a real-life study of 12 patients with severe type-2 asthma, dupilumab treatment for 3 months led to significant improvements in asthma control (ACT score) and lung function (FEV1), indicating its efficacy in managing symptoms.

The treatment also resulted in a notable reduction in FeNO levels, a biomarker for type-2 inflammation, although blood eosinophil counts did not show significant change, suggesting that dupilumab effectively targets the IL4/IL13 pathway in asthma management.

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]

Dupilumab, a monoclonal antibody that blocks IL-4 and IL-13 signaling, has been shown to significantly improve asthma symptoms and reduce exacerbation rates in adolescents and adults, based on Phase II and III clinical trials.

The treatment has a favorable safety profile and has also been approved for use in atopic dermatitis, highlighting its effectiveness across multiple atopic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 46 adult patients with moderate-to-severe atopic dermatitis treated with dupilumab, 34.8% experienced ocular adverse events (OAEs), primarily mild to moderate dry eye disease and superficial punctate keratitis.

Patients with pre-existing conditions such as dry eye disease, eyelid eczema, or high IgE levels were more likely to develop OAEs, suggesting that these factors should be considered before starting dupilumab treatment.

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9574251/

Dupilumab efficacy and safety in patients with moderate to ... Compared to the placebo, dupilumab revealed a significantly higher incidence of upper respiratory tract infections (URTI), injection-site reaction, and ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1304048

Dupilumab in Persistent Asthma with Elevated Eosinophil ... The objective of this study was to assess the efficacy and safety of dupilumab in adults with persistent, moderate-to-severe asthma and elevated eosinophil ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Study of Dupilumab (REGN668/​SAR231893) ... Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02414854

Study Details | NCT02414854 | Evaluation of Dupilumab in ... A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23688323/

Dupilumab in persistent asthma with elevated eosinophil ... Dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations when LABAs and inhaled glucocorticoids were withdrawn, with ...

6. annallergy.org annallergy.org/article/S1081-1206(25)00203-0/fulltext

Patient outcomes and safety of combination biologic ... Combination biologic therapy with dupilumab is well-tolerated in select patients, suggesting promising efficacy in addressing comorbid conditions, refractory ...

7. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/sanofi-and-regeneron-report-positive-proof-concept-data

Sanofi and Regeneron Report Positive Proof-of-Concept ... Treatment with four weekly subcutaneous injections of dupilumab at either 150 milligrams (mg) or 300mg per week, significantly improved the signs and symptoms ...