Clinical trial NCT04203797: A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Key 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

Key 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
timeFrame: Up to week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
timeFrame: Up to week 12
measure: Change From Baseline to Week 12 in Total Energy Expenditure
timeFrame: Up to week 12
measure: Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
timeFrame: Up to week 12
measure: Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
timeFrame: Up to week 12
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)
state: California
city: Torrance
country: United States
facility: UCLA Medical Center - Harbor
state: California
city: Westminster
country: United States
facility: Allianz Research Institute
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine
state: Iowa
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Hendersonville
country: United States
facility: Regeneron Study Site
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Medical School at Houston
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Dijon
country: France
facility: CHU Dijon
state: Bourgogne
city: Reims
country: France
facility: CHU Reims
state: Marne
city: Strasbourg
country: France
facility: CHU de Strasbourg - Nouvel Hopital Civil
city: Aschaffenburg
country: Germany
facility: Praxis Dr. M. Rolke u. Dr. P. Rueckert
state: Bavaria
city: Frankfurt am Main
country: Germany
facility: Regeneron Study Site
state: Hessen
city: Frankfurt am Main
country: Germany
facility: IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG.
state: Hessen
city: Hannover
country: Germany
facility: Regeneron Study Site
state: Lower Saxony
city: Koblenz
country: Germany
facility: Regeneron Study Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
state: Rheinland-Pfalz
city: Grosshansdorf
country: Germany
facility: Regeneron Study Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: KLB - Gesundheitsforschung Luebeck GmbH
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Regeneron Study Site
city: Lubin
country: Poland
facility: Regeneron Study Site
state: Dolnoslaskie
city: Bialystok
country: Poland
facility: Centrum Medycyny Oddechowej, Mroz Spolka Jawna
city: Wroclaw
country: Poland
facility: Lekarze Specjalisci - J. Malolepszy i Partnerzy
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trials Management
role: STUDY_DIRECTOR
References: