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 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: R668-AS-23732023-510458-18-00
• Study Type: interventional
• Target: 120
• Locations: 6 countries
• Sites: 77

Brief 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

Asthma

Keywords

Uncontrolled; Severe exacerbations; Type 2 Inflammation; Elevated blood eosinophils; Increased Fractional exhaled Nitric Oxide (FeNO); Atopy and elevated Immunoglobulin E (IgE)

Outcome Measures

Primary Outcomes (1)

• Annualized severe asthma exacerbation rate

  Baseline through Week 52

Secondary Outcomes (14)

• Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1)

  Baseline to week 12

• Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations

  Baseline to week 52

• Change in Asthma Control Questionnaire (ACQ-5)

  Baseline to week 12

• Proportion of participants achieving ACQ-5 <1.5

  At week 12

• Change in pre-bronchodilator FEV1

  Baseline up to week 52

Study Arms (2)

Dupilumab + ICS/LABA

EXPERIMENTAL

Randomized 1:1

Drug: dupilumab; Drug: ICS/LABA

Placebo + ICS/LABA

PLACEBO COMPARATOR

Randomized 1:1

Drug: Matching Placebo; Drug: ICS/LABA

Interventions

dupilumab DRUG

Administered by subcutaneous (SC) injection

Also known as: Dupixent®, REGN668, SAR231893

Dupilumab + ICS/LABA

Matching Placebo DRUG

Administered by SC injection

Placebo + ICS/LABA

ICS/LABA DRUG

Administered at a blinded dose

Also known as: fluticasone, propionate/salmeterol HFA, inhalation aerosol

Dupilumab + ICS/LABA; Placebo + ICS/LABA

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
• Existing treatment with medium dose ICS/LABA (\>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
• Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
• Pre-bronchodilator FEV1, as defined in the protocol
• Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol
• Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
• ACQ-5 score ≥1.5 at screening (visit 1)
• History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
• Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (\~90% of population), as defined in the protocol

You may not qualify if:

• Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
• Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging \[MRI\]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)
• A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol
• Weight is less than 30 kilograms
• Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
• Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol
• Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (77)

Kern Research, Inc

Bakersfield, California, 93301, United States

Location

Modena Allergy & Asthma, Inc.

La Jolla, California, 92037, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Ark Clinical Research, LLC

Long Beach, California, 90815, United States

Location

Newport Native Md, Inc.

Newport Beach, California, 92663, United States

Location

Childrens Hospital of Orange County Main Campus

Orange, California, 92868, United States

Location

Raffi Tachdjian MD, Inc.

Santa Monica, California, 90404, United States

Location

Bensch Clinical Research

Stockton, California, 95207, United States

Location

Integrated Research of Inland, Inc.

Upland, California, 91786, United States

Location

Allianz Research Institute

Westminster, California, 92683, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

St Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

Kissimmee, Florida, 34746, United States

Location

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida, 32789, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Sneeze Wheeze and Itch Associates

Normal, Illinois, 61761, United States

Location

Asthma and Allergy Center of Chicago

River Forest, Illinois, 60305, United States

Location

Endeavor Health, Skokie Campus

Skokie, Illinois, 60077, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Bluegrass Allergy Research

Lexington, Kentucky, 40509, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40217, United States

Location

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301, United States

Location

Paul A. Shapero, M.D.

Bangor, Maine, 04401, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Clinical Research Institute, Inc.

Minneapolis, Minnesota, 55402, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63119, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

The Asthma and Allergy Center

Bellevue, Nebraska, 68123, United States

Location

Henderson Clinical Trials

Henderson, Nevada, 89052, United States

Location

Certified Research Associates

Cortland, New York, 13045, United States

Location

New York Medical College

Hawthorne, New York, 10532, United States

Location

Northwell Health at ENT & Allergy Associates

New York, New York, 10016, United States

Location

Rochester Regional Health - Alexander Park - Allergy, Immunology & Rheumatology

Rochester, New York, 14607, United States

Location

Cincinnati Childrens Hospital and Medical Center

Cincinnati, Ohio, 45229, United States

Location

Allergy Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States

Location

University of Pittsburgh Asthma and Environmental Health Lung Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Pulmonology Associates Inc.

Wynnewood, Pennsylvania, 19096, United States

Location

Dharma MD PA d/b/a Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

Premier Pulmonary Critical Care and Sleep Medicine

Denison, Texas, 75020, United States

Location

Western Sky Medical Research

El Paso, Texas, 79912, United States

Location

Baylor College of Medicine - Section of Pulmonary and Critical Care

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Metroplex Pulmonary and Sleep Center, PA

McKinney, Texas, 75069, United States

Location

Lung Sleep Research Institute

North Richland Hills, Texas, 76180, United States

Location

South Texas Allergy & Asthma Medical Professionals (STAAMP) Research

San Antonio, Texas, 78229, United States

Location

Allergy & Asthma Care of Waco

Waco, Texas, 76712, United States

Location

Intermountain Medical Center - Murray (Pulmonary Medicine)

Murray, Utah, 84107, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

The Lung Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5, Canada

Location

Evidence Based Medical Educator Inc.

Toronto, Ontario, M5G 1E2, Canada

Location

Inspiration Research Limited

Toronto, Ontario, M5T 3A9, Canada

Location

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Institut Universitare de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval

Québec, G1V 4G5, Canada

Location

Clinique de Specialisee en Allergie de la Capitale

Québec, G1V 4W2, Canada

Location

Vejle Sygehus

Vejle, Region Syddanmark, 7100, Denmark

Location

Praxis fur Pneumologie am Duako

Augsburg, Bavaria, 86150, Germany

Location

LMU University Hospital Munich

Munich, Bavaria, 81377, Germany

Location

IKF Pneumologie Frankfurt GmbH & Co KG

Frankfurt am Main, Hesse, 60596, Germany

Location

KPPK Studienzentrum

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Velocity Clinical Research Lubeck GmbH (Formerly KLB Gesundheitsforschung Lübeck GmbH)

Lübeck, Schleswig-Holstein, 23552, Germany

Location

Lungenpraxis Hohenzollerndamm RCMS

Berlin, 10717, Germany

Location

POIS Sachsen GmbH iG

Leipzig, 04347, Germany

Location

IKF Pneumologie GmbH & Co. KG

Mainz, 55128, Germany

Location

Centrum Medyczne All-Med

Krakow, Lesser Poland Voivodeship, 30-033, Poland

Location

Michał Bogacki - DOBROSTAN

Wroclaw, Lower Silesian Voivodeship, 53301, Poland

Location

Diamond Clinic sp zoo

Krakow, Malopolska, 31-559, Poland

Location

European Trial Group (ETG) Warsaw

Warsaw, Mazovian, 02-677, Poland

Location

Centrum Medycyny Oddechowej Mroz SJ

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

Allergy Clinic NZOZ Homeo Medicus

Bialystok, Podlaskie Voivodeship, 15-687, Poland

Location

Uniwersyteckie Centrum Kliniczne, Budynek Centrum Medycyny Nieinwazyjnej

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Lekarze Specjaliści Małolepszy i Partnerzy

Wroclaw, 54239, Poland

Location

ALL-MED Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

Wroclaw, PL-53-201, Poland

Location

PRCCI Clinical Research Center

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Asthma

Interventions

dupilumab; Fluticasone; Propionates

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): April 24, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has : * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

PL (9); US (51); DE (8); CA (7); DK (1); PR (1)