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Monoclonal Antibodies

Dupilumab + ICS/LABA for Asthma (AIM4:Next Step Trial)

Phase 4
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Key
3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is looking at a drug called dupilumab for patients with uncontrolled asthma. Uncontrolled asthma means patients still have symptoms even with their current medication. The study will compare the effectiveness of

Who is the study for?
This trial is for adolescents and adults who have had asthma for at least a year, are currently on medium dose ICS/LABA, and still experience frequent symptoms. They should have had at least one severe asthma attack in the past year but not within the last 30 days. Participants must also meet certain lung function criteria and blood eosinophil levels.
What is being tested?
The study compares two treatments: adding dupilumab to an existing medium dose of ICS/LABA versus increasing the ICS/LABA dosage alone. The goal is to determine which approach better controls asthma symptoms.
What are the potential side effects?
Potential side effects from taking dupilumab may include allergic reactions, eye inflammation or irritation, joint pain, injection site reactions, headache, and cold sores in your mouth or throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use up to 3 medications to control my asthma.
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I have been diagnosed with asthma for at least a year.
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My lung function improves significantly after using an inhaler or has a history of major decrease.
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I've been on a stable medium dose asthma treatment for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Asthma Control Questionnaire (ACQ-5)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dupilumab + ICS/LABAExperimental Treatment2 Interventions
Randomized 1:1
Group II: Placebo + ICS/LABAPlacebo Group2 Interventions
Randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2023
Completed Phase 4
~470

Find a Location

Who is running the clinical trial?

SanofiIndustry Sponsor
2,209 Previous Clinical Trials
4,039,516 Total Patients Enrolled
51 Trials studying Asthma
29,468 Patients Enrolled for Asthma
Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
386,252 Total Patients Enrolled
29 Trials studying Asthma
11,460 Patients Enrolled for Asthma
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
255,093 Total Patients Enrolled
5 Trials studying Asthma
1,129 Patients Enrolled for Asthma
~167 spots leftby Dec 2026
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