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

Regeneron Pharmaceuticals24 sites in 5 countries40 target enrollmentJuly 16, 2020

ConditionsAsthma

Interventionsdupilumab Matching placebo

Drugsdupilumab Matching placebo

Overview

Phase: Phase 4
Intervention: dupilumab
Conditions: Asthma
Sponsor: Regeneron Pharmaceuticals
Enrollment: 40
Locations: 24
Primary Endpoint: Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 16, 2020

End Date

July 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

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

Arms & Interventions

dupilumab

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

Intervention: dupilumab

Matching placebo

Matching dupilumab

Intervention: Matching placebo

Outcomes

Primary Outcomes

Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time - CWRET (Constant Work Rate Exercise Test)

Time Frame: 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 Outcomes

Change From Baseline to Week 12 in Average Number of Steps Walked Per Day(Up to week 12)
Change From Baseline to Week 12 in Total Energy Expenditure(Up to week 12)
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity(Up to week 12)
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)(Up to week 12)