ClinicalTrials.gov record
Recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT06572228

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.

ClinicalTrials.gov public records Last synced Apr 23, 2026, 7:08 AM EDT

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Riviera Allergy Medical Center Redondo Beach California 90277 Withdrawn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.

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