A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
- Registration Number
- NCT04203797
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
Key
- 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
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dupilumab dupilumab A loading dose at the start of the treatment followed by once every two weeks (Q2W). Matching placebo Matching placebo Matching dupilumab
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test) Up to week 12 CWRET (Constant Work Rate Exercise Test) will be performed on an electromagnetically-braked cycle ergometer in an exercise physiology laboratory overseen by a trained pulmonologist or medical doctor designee.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 12 in Average Number of Steps Walked Per Day Up to week 12 Based on accelerometry data
Change From Baseline to Week 12 in Total Energy Expenditure Up to week 12 Metabolic equivalents of tasks \[METs\]. Based on accelerometry data
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity Up to week 12 Defined as ≥3 METs. Based on accelerometry data
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1) Up to week 12 Based on spirometry data
Trial Locations
- Locations (24)
Regeneron Study Site
🇵🇱Lubin, Dolnoslaskie, Poland
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, Hessen, Germany
IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
UCLA Medical Center - Harbor
🇺🇸Torrance, California, United States
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Allianz Research Institute
🇺🇸Westminster, California, United States
The University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
KLB - Gesundheitsforschung Luebeck GmbH
🇩🇪Luebeck, Schleswig-Holstein, Germany
CHU Reims
🇫🇷Reims, Marne, France
Praxis Dr. M. Rolke u. Dr. P. Rueckert
🇩🇪Aschaffenburg, Bavaria, Germany
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
🇵🇱Bialystok, Poland
CHU de Strasbourg - Nouvel Hopital Civil
🇫🇷Strasbourg, France
Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)
🇺🇸Rolling Hills Estates, California, United States
Infinity Medical Research
🇺🇸North Dartmouth, Massachusetts, United States
University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine
🇺🇸Iowa City, Iowa, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
CHU Dijon
🇫🇷Dijon, Bourgogne, France
Lekarze Specjalisci - J. Malolepszy i Partnerzy
🇵🇱Wroclaw, Poland
Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)
🇪🇸Madrid, Spain
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University Of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States