A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma

NCT ID: NCT04203797

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2023-07-15

Brief Summary

The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.

The secondary objectives of the study are:

• To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma
• To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dupilumab

A loading dose at the start of the treatment followed by once every two weeks (Q2W).

Group Type: EXPERIMENTAL

dupilumab

Intervention Type: DRUG

Pre-filled syringe administered by subcutaneous (SC) injections

Matching placebo

Matching dupilumab

Group Type: EXPERIMENTAL

Matching placebo

Intervention Type: DRUG

Pre-filled syringe administered by subcutaneous (SC)

Interventions

dupilumab

Pre-filled syringe administered by subcutaneous (SC) injections

Intervention Type: DRUG

Matching placebo

Pre-filled syringe administered by subcutaneous (SC)

Intervention Type: DRUG

Other Intervention Names

Dupixent®; SAR231893

Eligibility Criteria

Inclusion Criteria

• A physician diagnosis of asthma
• Pre-bronchodilator FEV1 between 30% and 75% predicted at both the screening and baseline visits
• Bronchodilator reversibility defined as >200 mL and 12% increase in FEV1 post-administration of a short-acting beta agonist (SABA). A patient may also qualify if there is a documented history of bronchodilator reversibility or positive methacholine challenge test within 12 months prior to the screening visit
• Stable background therapy for at least 3 months with a stable dose ≥4 weeks prior to the baseline visit of a medium-to-high dose ICS (fluticasone propionate ≥250 to 1000 μg twice daily [BID] or equivalent) in combination with at least a second controller medication (eg, long-acting beta agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene receptor antagonist [LTRA], theophylline, etc.); a third controller is allowed and with the same stabilization requirements
• Blood eosinophil count ≥300 cells/μL for patients not on maintenance OCS at the screening visit
• ACQ-5 score ≥1.5 at the screening and baseline visits

Exclusion Criteria

• Body mass index >35 kg/m2 at screening
• Current smoking, vaping or tobacco chewing or cessation of any of these within 6 months prior to randomization, or >10 pack years smoking history
• Patients who require supplemental oxygen at screening
• Clinically significant cardiac disease as described in the protocol
• Uncontrolled hypertension at screening or baseline
• Participation in exercise or physical rehabilitation program within last 6 months prior to screening or planned during the study
• Previous use of dupilumab
• Anti-IgE therapy (eg, omalizumab [Xolair®]) within 130 days prior to visit 1 or any other biologic therapy (including anti-IL5, anti-IL-5R, anti-IL4Rα, anti-IL-13 mAb) or systemic immunosuppressant (eg, methotrexate, any anti-tumor necrosis factor mAbs, Janus kinase inhibitors, B- and/or T-cell targeted immunosuppressive therapies) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) and other diseases, within 3 months or 5 half-lives prior to screening, whichever is longer
• Exposure to another investigative drug (monoclonal antibodies as well as small molecules) within a period prior to screening, of <3 months or <5 half-lives (whichever is longer)
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
• Women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)

Rolling Hills Estates, California, United States

UCLA Medical Center - Harbor

Torrance, California, United States

Allianz Research Institute

Westminster, California, United States

University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine

Iowa City, Iowa, United States

University Of Kansas Medical Center

Kansas City, Kansas, United States

Infinity Medical Research

North Dartmouth, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

American Health Research

Charlotte, North Carolina, United States

UH Cleveland Medical Center

Cleveland, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Regeneron Study Site

Hendersonville, Tennessee, United States

The University of Texas Medical School at Houston

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

CHU Dijon

Dijon, Bourgogne-Franche-Comté, France

CHU Reims

Reims, Marne, France

CHU de Strasbourg - Nouvel Hopital Civil

Strasbourg, , France

Praxis Dr. M. Rolke u. Dr. P. Rueckert

Aschaffenburg, Bavaria, Germany

Regeneron Study Site

Frankfurt am Main, Hesse, Germany

IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG.

Frankfurt am Main, Hesse, Germany

Regeneron Study Site

Hanover, Lower Saxony, Germany

Regeneron Study Site

Koblenz, Rhineland-Palatinate, Germany

IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

Mainz, Rhineland-Palatinate, Germany

Regeneron Study Site

Großhansdorf, Schleswig-Holstein, Germany

KLB - Gesundheitsforschung Luebeck GmbH

Lübeck, Schleswig-Holstein, Germany

Regeneron Study Site

Berlin, , Germany

Regeneron Study Site

Lubin, Lower Silesian Voivodeship, Poland

Centrum Medycyny Oddechowej, Mroz Spolka Jawna

Bialystok, , Poland

Lekarze Specjalisci - J. Malolepszy i Partnerzy

Wroclaw, , Poland

Hospital Universitario de Bellvitge

Barcelona, , Spain

Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)

Madrid, , Spain

Countries

United States; France; Germany; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002742-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R668-AS-1903

Identifier Type: -

Identifier Source: org_study_id