Dupilumab for Allergic Asthma

Recruiting at 1 trial location

Overseen By Alisha Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Glucocorticosteroids, JAK-1 inhibitors, Biologics, others

Disqualifiers: Chronic lung disease, Atopic dermatitis, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 18 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing dupilumab for individuals with allergic asthma. Researchers aim to determine if dupilumab can reduce asthma symptoms and improve breathing compared to a placebo. Participants will be divided into groups receiving either the study drug or a placebo. The trial seeks individuals who have experienced year-round nasal allergy symptoms for at least two years and have asthma affecting their daily life. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications, including intranasal steroids, asthma medications, systemic glucocorticosteroids, and JAK-1 inhibitors, for specific times before and during the study. If you are taking any of these, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dupilumab is generally safe for people. Studies have found that it improves breathing and reduces swelling in individuals with asthma. Importantly, these studies report very few side effects, indicating that most participants did not experience serious problems. In fact, past patients with moderate to severe asthma tolerated dupilumab well, suggesting that people can usually take it without major issues. Overall, the evidence supports dupilumab as a safe treatment option with few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Dupilumab for allergic asthma because it targets the underlying drivers of the disease in a new way. Unlike traditional treatments like inhaled corticosteroids and bronchodilators that mainly address symptoms, Dupilumab blocks the activity of interleukin-4 and interleukin-13, two proteins involved in the inflammatory response. This novel mechanism of action has the potential to reduce inflammation more effectively and improve lung function. Additionally, Dupilumab is administered via injection, which may offer longer-lasting relief compared to daily inhaled medications.

What evidence suggests that this trial's treatments could be effective for allergic asthma?

Research shows that dupilumab effectively treats severe allergic asthma. Studies found that people using dupilumab experienced fewer asthma attacks and required less emergency care. One study showed a 44% reduction in asthma flare-ups after starting dupilumab. It also improved overall asthma symptoms and quality of life. In this trial, researchers will randomize participants into different groups, with some receiving dupilumab and others a placebo. These findings suggest that dupilumab could be a promising option for managing allergic asthma symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Sunil K Ahuja, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

Adults aged 18-65 with perennial nasal allergy for at least 2 years, positive skin test to house dust mites, and asthma can join. They must use reliable birth control if applicable, not smoke currently or heavily in the past, have COVID-19 vaccination or recent infection proof, and test negative for SARS-CoV-2 before visits.

Inclusion Criteria

I will test negative for COVID-19 before each treatment visit.

Women of childbearing potential must agree to a medically acceptable form of birth control throughout the study duration and for at least 2 months prior to Visit 1.

My asthma shows improvement in lung function tests by at least 10% in the last year.

Exclusion Criteria

Known hypersensitivity to dupilumab or any of its excipients.

I have had issues with severe nasal problems or deformities.

Home oxygen requirement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial HDM Exposure

Participants undergo initial HDM exposure in the Aeroallergen Challenge Chamber for precision phenotyping

1 week

1 visit (in-person)

Treatment

Participants are randomized to receive either dupilumab or placebo for 18 weeks with intermittent HDM exposures

18 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab

Trial Overview The trial tests dupilumab's effects on allergic reactions by exposing participants to house dust mites in a controlled setting. Some will receive dupilumab while others get a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Maladaptive Phenotypes randomized to study drug Experimental Treatment 2 Interventions

This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug.

Group II: Adaptive Phenotypes randomized to study drug Active Control 2 Interventions

This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug.

Group III: Adaptive Phenotype randomized to placebo Placebo Group 2 Interventions

This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo.

Group IV: Maladaptive Phenotype randomized to placebo Placebo Group 2 Interventions

This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo.

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?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

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]

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 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]

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]

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, effectively reducing severe asthma exacerbations and improving lung function in patients aged 12 and older with moderate-to-severe asthma, based on three pivotal trials lasting 24-52 weeks.

The treatment is generally well tolerated and allows for a reduction in oral corticosteroid doses without compromising asthma control, particularly benefiting patients with higher levels of type 2 inflammation, such as those with elevated eosinophils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab: A Review in Moderate to Severe Asthma. Deeks, ED.[2020]

Citations

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Dupilumab Effectiveness in Patients with Severe Allergic ... Asthma Outcomes After Switching to Dupilumab. After one year of dupilumab, we observed a significant decrease in the exacerbation rate (2.60 ...

2. jaci-global.org jaci-global.org/article/S2772-8293(25)00134-1/pdf

Long-term outcomes of dupilumab therapy in severe asthma Conclusions: Dupilumab represents an effective long-term treatment option for patients with severe asthma, with sustained treatment effects up ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1804092

Dupilumab Efficacy and Safety in Moderate-to-Severe ... In this trial, patients who received dupilumab had significantly lower rates of severe asthma exacerbation than those who received placebo, as well as better ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1081120620303896

Efficacy of dupilumab on clinical outcomes in patients with ... In conclusion, dupilumab improved key asthma-related outcomes, suppressed type 2 inflammatory biomarkers, and improved rhinoconjunctivitis-related QoL in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37967668/

Real-world effectiveness of dupilumab in patients with ... After initiation of dupilumab, risk of asthma exacerbation was reduced by 44% (IRR, 0.56; 95% CI, 0.47-0.57; P = <0.0001) and systemic corticosteroid ...

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

Dupilumab efficacy and safety in patients with moderate to ... Conclusion: Dupilumab improves pulmonary function and reduces local and systemic inflammatory markers with minimal adverse events in patients ...

7. 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02277769

NCT02277769 | Study of Dupilumab (REGN668/ ... Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223 ...

9. 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 ...

10. 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 ...