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

Trial Summary

What is the purpose of this trial?

The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.

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.

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

Dupilumab has been shown to reduce severe asthma attacks, improve lung function, and enhance asthma control in patients with moderate-to-severe asthma, especially those with type 2 inflammation. It is generally well tolerated and can help reduce the need for oral corticosteroids without worsening asthma control. ^{1 2 3 4 5}

Is dupilumab generally safe for humans?

Dupilumab is generally considered safe for treating moderate to severe asthma, with minimal adverse events reported. However, it may cause increased blood eosinophils (a type of white blood cell) and ocular adverse events, especially in patients treated for atopic dermatitis. ^{1 2 3 6 7}

How is the drug Dupilumab different from other asthma treatments?

Dupilumab is unique because it is a monoclonal antibody that targets the interleukin-4 and interleukin-13 signaling pathways, which are involved in type 2 inflammation, making it effective for both eosinophilic and non-eosinophilic severe asthma. This mechanism of action is different from other biologics like omalizumab, mepolizumab, and reslizumab, which target different pathways. ^{1 2 4 6 8}

Research Team

Sunil K Ahuja, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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.

I am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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 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 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]

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

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

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

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

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

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. Switzerland pubmed.ncbi.nlm.nih.gov

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