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
Public ClinicalTrials.gov record NCT06572228. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma
Study identification
- NCT ID
- NCT06572228
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Regeneron Pharmaceuticals
- Industry
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
- ICS/LABA Drug
- Matching Placebo Drug
- dupilumab Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2024
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Apr 21, 2026
2024 – 2026
United States locations
- U.S. sites
- 55
- U.S. states
- 23
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kern Research, Inc | Bakersfield | California | 93301 | Active, not recruiting |
| Modena Allergy & Asthma, Inc. | La Jolla | California | 92037 | Active, not recruiting |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | Active, not recruiting |
| Ark Clinical Research, LLC | Long Beach | California | 90815 | Active, not recruiting |
| Newport Native Md, Inc. | Newport Beach | California | 92663 | Active, not recruiting |
| Childrens Hospital of Orange County Main Campus | Orange | California | 92868 | Recruiting |
| Riviera Allergy Medical Center | Redondo Beach | California | 90277 | Withdrawn |
| Raffi Tachdjian MD, Inc. | Santa Monica | California | 90404 | Completed |
| Bensch Clinical Research | Stockton | California | 95207 | Active, not recruiting |
| Integrated Research of Inland, Inc. | Upland | California | 91786 | Completed |
| Allianz Research Institute | Westminster | California | 92683 | Active, not recruiting |
| National Jewish Health | Denver | Colorado | 80206 | Active, not recruiting |
| St Francis Medical Institute | Clearwater | Florida | 33765 | Active, not recruiting |
| Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration | Kissimmee | Florida | 34746 | Active, not recruiting |
| Clinical Site Partners, LLC DBA Flourish Research | Winter Park | Florida | 32789 | Active, not recruiting |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | Active, not recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Withdrawn |
| Sneeze Wheeze and Itch Associates | Normal | Illinois | 61761 | Active, not recruiting |
| Asthma and Allergy Center of Chicago | River Forest | Illinois | 60305 | Active, not recruiting |
| Endeavor Health, Skokie Campus | Skokie | Illinois | 60077 | Active, not recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Active, not recruiting |
| Bluegrass Allergy Research | Lexington | Kentucky | 40509 | Active, not recruiting |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40217 | Recruiting |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | Active, not recruiting |
| Paul A. Shapero, M.D. | Bangor | Maine | 04401 | Active, not recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | Active, not recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Active, not recruiting |
| Allergy and Asthma Center of Minnesota | Maplewood | Minnesota | 55109 | Withdrawn |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | Active, not recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63119 | Active, not recruiting |
| Montana Medical Research | Missoula | Montana | 59808 | Active, not recruiting |
| The Asthma and Allergy Center | Bellevue | Nebraska | 68123 | Active, not recruiting |
| Henderson Clinical Trials | Henderson | Nevada | 89052 | Active, not recruiting |
| Certified Research Associates | Cortland | New York | 13045 | Active, not recruiting |
| New York Medical College | Hawthorne | New York | 10532 | Recruiting |
| Northwell Health at ENT & Allergy Associates | New York | New York | 10016 | Recruiting |
| Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology | Rochester | New York | 14607 | Active, not recruiting |
| Cincinnati Childrens Hospital and Medical Center | Cincinnati | Ohio | 45229 | Recruiting |
| Allergy Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | Active, not recruiting |
| Clinical Research Associates of Central PA | DuBois | Pennsylvania | 15801 | Completed |
| University of Pittsburgh Asthma and Environmental Health Lung Institute | Pittsburgh | Pennsylvania | 15213 | Active, not recruiting |
| Pulmonology Associates Inc. | Wynnewood | Pennsylvania | 19096 | Recruiting |
| Dharma MD PA d/b/a Southwest Family Medicine Associates | Dallas | Texas | 75235 | Active, not recruiting |
| Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas | 75020 | Active, not recruiting |
| Western Sky Medical Research | El Paso | Texas | 79912 | Active, not recruiting |
| Baylor College of Medicine - Section of Pulmonary and Critical Care | Houston | Texas | 77030 | Active, not recruiting |
| Texas Children's Hospital | Houston | Texas | 77030 | Active, not recruiting |
| Metroplex Pulmonary and Sleep Center, PA | McKinney | Texas | 75069 | Active, not recruiting |
| Lung Sleep Research Institute | North Richland Hills | Texas | 76180 | Active, not recruiting |
| South Texas Allergy & Asthma Medical Professionals (STAAMP) Research | San Antonio | Texas | 78229 | Active, not recruiting |
| Allergy & Asthma Care of Waco | Waco | Texas | 76712 | Active, not recruiting |
| Intermountain Medical Center - Murray (Pulmonary Medicine) | Murray | Utah | 84107 | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | Completed |
| Vancouver Clinic | Vancouver | Washington | 98664 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06572228, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2026 · Synced Apr 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06572228 live on ClinicalTrials.gov.