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Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma
NCT06572228 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab
Conditions Studied
Interventions
- DRUG dupilumab
- DRUG Matching Placebo
- DRUG ICS/LABA
Study Locations (20)
California
- Kern Research, Inc — Bakersfield
- Modena Allergy & Asthma, Inc. — La Jolla
- Antelope Valley Clinical Trials — Lancaster
- Ark Clinical Research - Long Beach — Long Beach
- Newport Native Md, Inc. — Newport Beach
- Childrens Hospital of Orange County Main Campus — Orange
- Riviera Allergy Medical Center — Redondo Beach
- Raffi Tachdjian MD, Inc. — Santa Monica
- Bensch Clinical Research — Stockton
- Integrated Research of Inland, Inc. — Upland
- Allianz Research Institute — Westminster
Illinois
- Northwestern University — Chicago
- Sneeze Wheeze and Itch Associates — Normal
- Asthma and Allergy Center of Chicago — River Forest
- NorthShore University Health System — Skokie
Florida
- St Francis Medical Institute — Clearwater
- Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration — Kissimmee
- Clinical Site Partners, LLC DBA Flourish Research — Winter Park
Colorado
- National Jewish Health — Denver
Idaho
- Treasure Valley Medical Research — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06572228
The ClinicalTrials.gov registry entry for NCT06572228 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions — of which dupilumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06572228 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06572228 about?
NCT06572228 is a clinical study titled "Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma". This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their cu...
What is the current status of trial NCT06572228?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 250 participants. The study started on 2024-08-26. Estimated completion is 2026-12-31.
What conditions does trial NCT06572228 study?
This clinical trial studies the following conditions: Asthma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06572228?
The interventions under investigation include: dupilumab (DRUG), Matching Placebo (DRUG), ICS/LABA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06572228?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06572228 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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