What side effects are associated with this type of intervention?

Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, is commonly used for treating moderate to severe asthma. Known side effects of Dupilumab include injection site reactions, upper respiratory tract infections, headache, and nasopharyngitis. Other common asthma treatments, such as inhaled corticosteroids, can cause oral thrush, hoarseness, and coughing, while long-acting beta-agonists may lead to muscle cramps, rapid heartbeat, and tremors. Leukotriene modifiers, another class of asthma medications, can cause headaches, dizziness, and abdominal pain.

What prior FDA approvals exist?

Dupilumab, a monoclonal antibody that inhibits IL-4 and IL-13 signaling, has been approved by the FDA for the treatment of moderate to severe asthma. Similar treatments include Benralizumab, which targets the IL-5 receptor, and Omalizumab, which targets IgE. These biologic agents are used for patients with severe asthma that is inadequately controlled with standard therapies.

What other types of research exist?

Promising alternatives to Dupilumab for asthma patients include Tezepelumab (targets TSLP), Benralizumab (targets IL-5R), Mepolizumab (targets IL-5), and Lebrikizumab (targets IL-13). These agents are either approved or in advanced stages of clinical trials and offer different mechanisms of action for managing asthma.

Monoclonal Antibodies

Dupilumab for Asthma (ATLAS Trial)

Southfield, MI

Phase 4

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Participant must be at least 18 years of age at the time of signing the informed consent

History of ≥1 severe exacerbation(s) in the previous year before V1

Must not have

Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 or during the screening period

History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8 to week 156

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing dupilumab, a medication that reduces lung inflammation, in adults with moderate to severe asthma that isn't controlled by usual treatments. It aims to see if dupilumab can help improve breathing and slow down lung damage.

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Who is the study for?

Adults with uncontrolled moderate to severe asthma who have had a recent asthma attack requiring steroids or an ER visit, poor lung function (FEV1 ≤ 80%), and not well controlled on current meds. Must be non-smokers for at least 6 months and without other significant health issues like active infections, cancer in the past 5 years, or immune system problems.Check my eligibility

What is being tested?

The trial is testing Dupilumab against a placebo to see if it can slow down worsening of lung function in adults with serious asthma. Participants will either get Dupilumab or a fake drug (placebo) alongside their regular treatments for three years, without knowing which one they're getting.See study design

What are the potential side effects?

Dupilumab may cause injection site reactions, eye inflammation or irritation, joint pain, and allergic reactions. It might also increase the risk of cold sores around your mouth or an increased count of a type of white blood cell called eosinophils.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have had one or more severe flare-ups in the past year.

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My lung function improved significantly after using a quick-relief inhaler.

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I am at least 18 years old or the legal age of consent where the study is conducted.

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I have used corticosteroids for more than 3 days or was hospitalized for asthma.

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My asthma control score is 1.5 or higher.

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My lung function test shows less than 80% of the normal airflow.

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I have been diagnosed with asthma for at least a year.

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I have been diagnosed with asthma for at least a year.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine within the last 4 weeks.

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I am HIV positive.

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I have active TB, a non-tuberculous mycobacterial infection, or untreated TB history.

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I am currently experiencing severe asthma attacks.

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I am not currently on antibiotics, antivirals, or antifungals for an infection.

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I have a lung or systemic disease linked to high eosinophil counts, not asthma.

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I have a weak immune system or history of serious infections.

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I have a chronic lung condition like COPD or severe asthma.

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I have smoked more than 10 pack-years.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8 to week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8 to week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 to week 156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population

Secondary study objectives

Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations

Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations

Change from baseline to week 104 FVC in FeNO and Total populations

+19 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

12%

Accidental Overdose

Nasopharyngitis

Dermatitis Atopic

Conjunctivitis

Headache

Fall

Multiple Fractures

100%

80%

60%

40%

20%

Study treatment Arm

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

DB Period: Placebo

DB Period: Dupilumab

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DupilumabExperimental Treatment1 Intervention

Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

2017

Completed Phase 4

~11960

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies like Dupilumab work by inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, which are key cytokines involved in the inflammatory response in asthma. By blocking these pathways, Dupilumab reduces inflammation and helps control asthma symptoms. Other monoclonal antibodies, such as Mepolizumab, target IL-5 to reduce eosinophil levels, another contributor to inflammation. These targeted therapies are crucial for patients with severe asthma as they offer a more precise approach to managing the disease, potentially reducing the frequency and severity of asthma attacks compared to traditional treatments like inhaled corticosteroids and bronchodilators.