AsthmaPhase 4NCT04203797
A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
A Phase 4 study testing dupilumab in people with Asthma, run by Regeneron Pharmaceuticals at 30 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 30 sitesin 5 countries
- Study dates
- 16 Jul 2020to 15 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
American Health Research
Charlotte, North Carolina, 28277
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Regeneron Study Site
Hendersonville, Tennessee, 37075
The University of Texas Medical School at Houston
Houston, Texas, 77030
University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine
Iowa City, Iowa, 52242
University Of Kansas Medical Center
Kansas City, Kansas, 66160
Intermountain Medical Center
Murray, Utah, 84107
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)
Rolling Hills Estates, California, 90274
UCLA Medical Center - Harbor
Torrance, California, 90509
Allianz Research Institute
Westminster, California, 92683
Germany9 sites
Praxis Dr. M. Rolke u. Dr. P. Rueckert
Aschaffenburg, Bavaria, 63739
Regeneron Study Site
Berlin, 12159
Regeneron Study Site
Frankfurt am Main, Hesse, 60389
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, 60596
Regeneron Study Site
Großhansdorf, Schleswig-Holstein, 22977
Regeneron Study Site
Hanover, Lower Saxony, 30625
Regeneron Study Site
Koblenz, Rhineland-Palatinate, 56068
KLB - Gesundheitsforschung Luebeck GmbH
Lübeck, Schleswig-Holstein, 486344
IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz
Mainz, Rhineland-Palatinate, 55128
France3 sites
CHU Dijon
Dijon, Bourgogne-Franche-Comté, 21000
CHU Reims
Reims, Marne, 51092
CHU de Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
Poland3 sites
Centrum Medycyny Oddechowej, Mroz Spolka Jawna
Bialystok, 15-044
Regeneron Study Site
Lubin, Lower Silesian Voivodeship, 59-300
Lekarze Specjalisci - J. Malolepszy i Partnerzy
Wroclaw, 54-239
Spain2 sites
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)
Madrid, 28007
About this study
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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called Dupixent®, SAR231893
Pre-filled syringe administered by subcutaneous (SC) injections
Matching placeboDrug
Pre-filled syringe administered by subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| dupilumab | Experimental | A loading dose at the start of the treatment followed by once every two weeks (Q2W). Receives: Drug: dupilumab |
| Matching placebo | Experimental | Matching dupilumab Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to week 12
Secondary outcomes (4)
Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
Based on accelerometry data
Measured: Up to week 12
Change From Baseline to Week 12 in Total Energy Expenditure
Metabolic equivalents of tasks [METs]. Based on accelerometry data
Measured: Up to week 12
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
Defined as ≥3 METs. Based on accelerometry data
Measured: Up to week 12
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Based on spirometry data
Measured: Up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start16 Jul 2020
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203797
- Sponsor's protocol ID
- R668-AS-1903
- Other IDs
- 2019-002742-20, 2019
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2019
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04203797
- Acronym / sponsor ID
- R668-AS-1903
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dupilumab | Experimental | Drug: dupilumabA loading dose at the start of the treatment followed by once every two weeks (Q2W). |
| Matching placebo | Experimental | Drug: Matching placeboMatching dupilumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: Dupixent®, SAR231893Pre-filled syringe administered by subcutaneous (SC) injections | Drug | dupilumab |
| Matching placeboPre-filled syringe administered by subcutaneous (SC) | Drug | Matching placebo |
Primary outcome
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.
4 secondary outcomes
Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
Time frame: Up to week 12
Change From Baseline to Week 12 in Total Energy Expenditure
Time frame: Up to week 12
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
Time frame: Up to week 12
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second (FEV1)
Time frame: Up to week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials Management study director
Regeneron Pharmaceuticals
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dupilumab in people with Asthma, run by Regeneron Pharmaceuticals at 30 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, France, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.