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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203797
• Other study ID #: R668-AS-1903
• Secondary ID: 2019-002742-20
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2020
• Est. completion date: July 15, 2023

Study information

• Verified date: March 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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-IL4Ra, 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• dupilumab
Pre-filled syringe administered by subcutaneous (SC) injections
• Matching placebo
Pre-filled syringe administered by subcutaneous (SC)

Locations

Country	Name	City	State
France	CHU Dijon	Dijon	Bourgogne
France	CHU Reims	Reims	Marne
France	CHU de Strasbourg - Nouvel Hopital Civil	Strasbourg
Germany	Praxis Dr. M. Rolke u. Dr. P. Rueckert	Aschaffenburg	Bavaria
Germany	Regeneron Study Site	Berlin
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	Hessen
Germany	Regeneron Study Site	Frankfurt am Main	Hessen
Germany	Regeneron Study Site	Grosshansdorf	Schleswig-Holstein
Germany	Regeneron Study Site	Hannover	Lower Saxony
Germany	Regeneron Study Site	Koblenz	Rheinland-Pfalz
Germany	KLB - Gesundheitsforschung Luebeck GmbH	Luebeck	Schleswig-Holstein
Germany	IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz	Mainz	Rheinland-Pfalz
Poland	Centrum Medycyny Oddechowej, Mroz Spolka Jawna	Bialystok
Poland	Regeneron Study Site	Lubin	Dolnoslaskie
Poland	Lekarze Specjalisci - J. Malolepszy i Partnerzy	Wroclaw
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)	Madrid
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	Regeneron Study Site	Hendersonville	Tennessee
United States	The University of Texas Medical School at Houston	Houston	Texas
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	Intermountain Medical Center	Murray	Utah
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)	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.	Up to week 12
Secondary	Change From Baseline to Week 12 in Average Number of Steps Walked Per Day	Based on accelerometry data	Up to week 12
Secondary	Change From Baseline to Week 12 in Total Energy Expenditure	Metabolic equivalents of tasks [METs]. Based on accelerometry data	Up to week 12
Secondary	Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity	Defined as =3 METs. Based on accelerometry data	Up to week 12
Secondary	Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)	Based on spirometry data	Up to week 12