AsthmaPhase 4VESTIGENCT04400318
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
A Phase 4 study testing Dupilumab in people with Asthma, run by Sanofi at 65 sites in 13 countries.
Trial summary
Primary Objective: To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation… Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 109 participants
- Where
- 65 sitesin 13 countries
- Study dates
- 20 Jun 2020to 21 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
- History of ≥1 exacerbation(s) in the previous year
- Uncontrolled moderate to severe asthma (ACQ-5 ≥1.5) at visit (V)1 and V2, prior to randomization
- Pre-bronchodilator FEV1 ≤80% of predicted normal at V1 and V2, prior to randomization
- Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
- Blood eosinophil ≥300 cells /µL and FeNO ≥25 ppb during screening, prior to randomization
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- NOTES:
- Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to SV1 in the absence of OCS treatment are allowed.
- FeNO value to be checked for eligibility at V2 as well. -Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable ≥1 month prior V1 and during screening.
Who cannot join
- Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization
- Previous smoker with a smoking history >10 pack-years
- Known hypersensitivity to dupilumab or any of its excipients
- A subject who experiences an asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids) during screening
- Current acute bronchospasm or status asthmaticus
- Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts
Show all 31Show fewer
- History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, etc)
- Active tuberculosis, latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection unless it is well documented by a specialist that the participants has been adequately treated and the treatment with a biologic agent can be initiated, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would only be performed on a country by country basis according to the routine clinical practice and the local guidelines, if required by regulatory authorities or ethics committees
- History of or current evidence of clinically significant disease in any non-respiratory system (e.g. cardiovascular, hepatic, nervous system, gastrointestinal, endocrinological, rheumatological, dermatological), which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study
- Current evidence of clinically significant oncological disease, which in the opinion of the investigator may interfere with the objectives of the study or put the subject at undue risk
- Participants with any of the following results at V1:
- Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or
- Positive Hepatitis B IgM core antibody (IgM HBc Ab) or
- Positive total hepatitis B core antibody (total HBc Ab) confirmed by positive HBV DNA or
- Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at V1
- Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant within 3 months prior to V1
- Treatment with live (attenuated) vaccine within 4 weeks before V1. For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician, whether the administration of vaccine can be postponed until after the end of the study, or preponed to before the start of the study without compromising the health of the participant:
- Participants for whom administration of live (attenuated) vaccine can be safely postponed would be eligible to enroll into the study.
- Participants who have their vaccination preponed can enroll in the study only after a gap of 4 weeks following administration of the vaccine.
- Treatment with oral corticosteroids (OCS) within 2 weeks prior to V1
- Enrolled in other ongoing studies regardless of the investigational product
- Treatment with an investigational drug within 1 month or within 5 half-lives (if known), whichever is longer, prior to V1
- Suspected or high risk of parasitic infection (helminthic infection), unless clinical and (if necessary) laboratory assessments have ruled out active infection prior to randomization
- Females who are lactating, breastfeeding, or who are pregnant
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized
- Participants are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6)
- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- Any country-related specific regulation that would prevent the subject from entering the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
65 sites in 13 countries.
65 sites in 13 countries
Bulgaria13 sites
Investigational Site Number : 1000013
Dupnitsa, 2600
Investigational Site Number : 1000004
Montana, 3403
Investigational Site Number : 1000018
Plovdiv, 4000
Investigational Site Number : 1000012
Plovdiv, 4002
Investigational Site Number : 1000008
Rousse, 7002
Investigational Site Number : 1000015
Sofia, 1000
Investigational Site Number : 1000005
Sofia, 1202
Investigational Site Number : 1000003
Sofia, 1233
Investigational Site Number : 1000006
Sofia, 1233
Investigational Site Number : 1000011
Sofia, 1407
Investigational Site Number : 1000010
Sofia, 1431
Investigational Site Number : 1000002
Sofia, 1680
Investigational Site Number : 1000007
Stara Zagora, 6001
United States10 sites
University of Michigan Site Number : 8400002
Ann Arbor, Michigan, 48109
Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Site Number : 8400009
Charleston, South Carolina, 29425
American Health Research Site Number : 8400005
Charlotte, North Carolina, 28277
The Lung Research Center Site Number : 8400010
Chesterfield, Missouri, 63017
VitaLink Research-Greenville Site Number : 8400013
Greenville, South Carolina, 29615
University of Kansas School of Medicine Site Number : 8400008
Kansas City, Kansas, 66103
Velocity Clinical Research, Medford Site Number : 8400014
Medford, Oregon, 97504
VitaLink Research - Spartanburg Site Number : 8400011
Spartanburg, South Carolina, 29303
~Spartanburg Medical Research Site Number : 8400004
Spartanburg, South Carolina, 29303
Allianz Research Institute Site Number : 8400020
Westminster, California, 92683
Romania6 sites
Investigational Site Number : 6420005
Bragadiru, 769764
Investigational Site Number : 6420008
Brasov, 500283
Investigational Site Number : 6420006
Cluj-Napoca, 400275
Investigational Site Number : 6420001
Cluj-Napoca, 400371
Investigational Site Number : 6420007
Oradea, 410155
Investigational Site Number : 6420003
Timișoara, 300134
Saudi Arabia6 sites
Investigational Site Number : 6820008
Dammam, 31952
Investigational Site Number : 6820004
Jeddah, 21423
Investigational Site Number : 6820006
Riyadh, 11426
Investigational Site Number : 6820001
Riyadh, 11525
Investigational Site Number : 6820002
Riyadh, 12372
Investigational Site Number : 6820010
Riyadh, 12746
Ukraine6 sites
Investigational Site Number : 8040003
Chernivtsi, 58001
Investigational Site Number : 8040001
Ivano-Frankivsk, 76018
Investigational Site Number : 8040002
Kharkiv, 61124
Investigational Site Number : 8040004
Kyiv, 01023
Investigational Site Number : 8040005
Odesa, 65025
Investigational Site Number : 8040007
Ternopil, 46000
Portugal5 sites
Investigational Site Number : 6200004
Coimbra, 3000-075
Investigational Site Number : 6200005
Guimarães, 4810-061
Investigational Site Number : 6200006
Lisbon, 1649-035
Investigational Site Number : 6200003
Porto, 4100-180
Investigational Site Number : 6200001
Porto, 4202-451
Denmark4 sites
Investigational Site Number : 2080006
Aarhus N, 8200
Investigational Site Number : 2080002
Copenhagen, 2100
Investigational Site Number : 2080003
Copenhagen Nv, 2400
Investigational Site Number : 2080001
Hvidovre, 2650
Spain4 sites
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240005
Madrid, Madrid, Comunidad de, 28041
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad de, 28046
Investigational Site Number : 7240002
Santiago de Compostela, Galicia [Galicia], 15706
Taiwan4 sites
Investigational Site Number : 1580004
Kaohsiung City, 807
Investigational Site Number : 1580002
Taichung, 40447
Investigational Site Number : 1580003
Tainan, 704
Investigational Site Number : 1580001
Taipei, 110
Italy3 sites
Investigational Site Number : 3800003
Cona, Ferrara, 44124
Investigational Site Number : 3800001
Pisa, 56124
Investigational Site Number : 3800004
Rozzano, Milano, 20089
United Kingdom2 sites
Investigational Site Number : 8260002
Bradford, BD9 6RJ
Investigational Site Number : 8260001
Leicester, Leicestershire, LE3 9QP
About this study
Official title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma
Primary Objective:
- To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging
Secondary Objective:
- To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
- To evaluate safety of dupilumab
Read the detailed description
The study duration for each participant was a total of minimum 29 weeks and up to 41 weeks. This included 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the participants switched to commercialized dupilumab (or other biologic products), whatever came first.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called SAR231893 Dupixent
solution for injection subcutaneous
PlaceboDrug
Solution for injection subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Participants received a loading dose of dupilumab 600 mg as 2 subcutaneous (SC) injections on Day 1, followed by a single dupilumab 300 mg SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. Receives: Drug: Dupilumab |
| Placebo | Placebo comparator | Participants received placebo matched to dupilumab as 2 x 2 mL SC injections on Day 1, followed by a single SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24
FeNO was analyzed using a NIOX instrument using a flow rate of 50 milliliters per second (mL/s). This assessment was conducted prior to spirometry and following a fast of greater than or equal to (≥1) hour. The test was performed after a wash out period of bronchodilators.
Measured: Week 24
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC)
Specific airway volume [(s)iVaw] is the change of volume of the airways (in mL), taking into account the lung volume changes (in liter [L]) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. This way the air volumes are normalized across participants and become specific. Untrimmed distal [s]iVaw at TLC was assessed based on 3-dimensional (D) rendering of high-resolution computed tomography (HRCT) scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of investigational medicinal product (IMP).
Measured: Baseline (Day 1) to Week 24
Secondary outcomes (11)
Change From Baseline to Week 24 in Global Lung Mucus Score (University of California, San Francisco [UCSF] Mucus Scoring)
The mucus scoring system was derived, with very minor differences, from UCSF mucus score. The mucus score was calculated by counting the number of bronchopulmonary segments which contained 1 or more mucus plug, up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway visible at TLC. Each bronchopulmonary segment is given a score of 1 (mucus plug[s] present) or 0 (mucus plug[s] absent). The segment scores of each lobe are summed to generate a total mucus score for both lungs, yielding a mucus score ranging from 0-18. Higher scores indicate worse outcome. Baseline was defined as the last available valid (non-missing) value up to and including the date of first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at TLC
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal ([s]iRaw) at TLC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Functional Residual Capacity (FRC)
(s)iVaw is the change of volume of the airways (mL), taking into account the lung volume changes (in L) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. Untrimmed distal [s]iVaw at FRC was assessed based on 3-D rendering of HRCT scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at FRC
iRaw is defined as the total pressure drop over an airway, divided by the flow rate through that airway. The specific airway resistance (s)iRaw is derived from iRaw by multiplying the airway resistance with the lobar volume. This way, the airway resistances are normalized across participants and become specific. Trimmed distal [s]iRaw at FRC was assessed using HRCT scan. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Global Lung Lobar Volumes (iVlobes) at TLC
The lung volume was determined from the HRCT scan at TLC, by identifying and grouping the voxels that represent the air in the lungs. The total lung volume along with the volume of each lobe individually was determined which allowed to pick up substantial regional physiological changes of the airways and the lobe volumes. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in HRCT-Based Internal Airflow Distribution (IAD) for Each Lung Zone
The IAD was assessed in the upper and lower lung using HRCT scan. By segmenting the lobes at FRC and TLC for each participant, the participant-specific airflow distribution can be established by assessing lobar and volume expansion. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Image-Based Ventilation/Perfusion (iV/Q) at TLC for Each Lung Zone
Blood vessel density can be considered a surrogate for perfusion, hence image-based perfusion (IQ) is calculated by blood vessel density at TLC multiplied by image-based volume at TLC. Image-based ventilation (IV) is calculated by the imaged volume at TLC subtracted from the image-based volume at FRC. The ventilation/perfusion ratio IV/Q is then the ratio IV/IQ. The iV/Q was assessed in the upper and lower lung using HRCT scan at TLC. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in FeNO
FeNO was analyzed using a NIOX instrument using a flow rate of 50 mL/s. This assessment was conducted prior to spirometry and following a fast of ≥1 hour. The test was performed after a wash out period of bronchodilators. Baseline was defined as the last available valid (non-missing) value up to and including the day of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration. Lung function parameters: pre- and post-bronchodilator FEV1 were measured by spirometry before IMP administration. Spirometry was performed after a wash out period of bronchodilators. Post-BD FEV1 was measured within 30 minutes after short-acting beta-2 agonists (2 to up to 4 puffs of albuterol/salbutamol) administration. Baseline was defined as the last available valid (non-missing) value up to and including the date of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in 7 Item Asthma Control Questionnaire (ACQ-7)
The ACQ-7 comprises of 7 items:first 5 items assess most common asthma symptoms: 1. frequency in past week awoken by asthma during the night; 2. severity of asthma symptoms in the morning; 3. limitation of daily activities due to asthma; 4. shortness of breath due to asthma; and 5. wheeze; plus questions 6. short-acting bronchodilator use; and 7. FEV1 (pre-bronchodilator use, % and % predicted use).Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment).Clinic staff scores the FEV1% predicted on a 7-point scale.A global score is calculated: the questions are equally weighted, and the overall ACQ-7 score is the mean of the 7 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled).Higher score indicates lower asthma control. Baseline=last available valid (non-missing) value up to and including day of the first dose of IMP.
Measured: Baseline (Day 1) to Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
AE: any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs: AEs that developed or worsened or became serious during the TEAE period, defined as the time from the first administration of the IMP (on Day 1) to the last administration of the IMP + 98 days and up to the end of the study follow-up. Serious adverse events (SAE): AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. AESI: AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required.
Measured: From first dose of study drug (Day 1) up to end of study (up to 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start20 Jun 2020
- Primary completion26 Jun 2023
- Study completion21 Aug 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400318
- Sponsor's protocol ID
- LPS15834
- Other IDs
- U1111-1238-4679, 2019-004647-74, 2019
- Acronym
- VESTIGE
- Status last verified
- Sep 2025
- First submitted
- 21 May 2020
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Porsbjerg C, Dunican EM, Lugogo NL, Castro M, Papi A, Backer V, Brightling CE, Bourdin A, Virchow JC, Zhang M, Soler X, Rowe PJ, Deniz Y, de Prado Gomez L, Sacks HJ, Jacob-Nara JA. Effect of dupilumab on mucus burden in patients with moderate-to-severe asthma: the VESTIGE trial. Am J Respir Crit Care Med. 2026 Feb 1;212(2):241-252. doi: 10.1164/rccm.202410-1894OC.
PubMed 41145399Castro M, Papi A, Porsbjerg C, Lugogo NL, Brightling CE, Gonzalez-Barcala FJ, Bourdin A, Ostrovskyy M, Staevska M, Chou PC, Duca L, Pereira AM, Fogarty C, Nadama R, Zhang M, Rodrigues A, Soler X, Sacks HJ, Deniz Y, Rowe PJ, de Prado Gomez L, Jacob-Nara JA. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025 Mar;13(3):208-220. doi: 10.1016/S2213-2600(24)00362-X. Epub 2025 Feb 10.
PubMed 39947221
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma
- ClinicalTrials.gov ID
- NCT04400318
- Acronym / sponsor ID
- VESTIGE / LPS15834
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging
Secondary Objective:
- To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
- To evaluate safety of dupilumab
Detailed description
The study duration for each participant was a total of minimum 29 weeks and up to 41 weeks. This included 4 weeks +/-1 week screening period, 24 weeks of treatment period and a follow-up period up to 12 weeks or until the participants switched to commercialized dupilumab (or other biologic products), whatever came first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: DupilumabParticipants received a loading dose of dupilumab 600 mg as 2 subcutaneous (SC) injections on Day 1, followed by a single dupilumab 300 mg SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo matched to dupilumab as 2 x 2 mL SC injections on Day 1, followed by a single SC injection Q2W for 24 weeks along with a stable dose of medium to high ICS dose in combination with a second controller medication +/- a third controller. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
- History of ≥1 exacerbation(s) in the previous year
- Uncontrolled moderate to severe asthma (ACQ-5 ≥1.5) at visit (V)1 and V2, prior to randomization
- Pre-bronchodilator FEV1 ≤80% of predicted normal at V1 and V2, prior to randomization
- Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
Key exclusion criteria (31 listed)
- Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization
- Previous smoker with a smoking history >10 pack-years
- Known hypersensitivity to dupilumab or any of its excipients
- A subject who experiences an asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids) during screening
- Current acute bronchospasm or status asthmaticus
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: SAR231893 Dupixentsolution for injection subcutaneous | Drug | Dupilumab |
| PlaceboSolution for injection subcutaneous | Drug | Placebo |
Primary outcome
Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24
Time frame: Week 24
FeNO was analyzed using a NIOX instrument using a flow rate of 50 milliliters per second (mL/s). This assessment was conducted prior to spirometry and following a fast of greater than or equal to (≥1) hour. The test was performed after a wash out period of bronchodilators.
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC)
Time frame: Baseline (Day 1) to Week 24
Specific airway volume [(s)iVaw] is the change of volume of the airways (in mL), taking into account the lung volume changes (in liter [L]) as well. It corresponds to the ratio between the airway volume (iVaw) and the lobar volume. This way the air volumes are normalized across participants and become specific. Untrimmed distal [s]iVaw at TLC was assessed based on 3-dimensional (D) rendering of high-resolution computed tomography (HRCT) scans. Baseline was defined as the last available valid (non-missing) value up to and including the day of first dose of investigational medicinal product (IMP).
11 secondary outcomes
Change From Baseline to Week 24 in Global Lung Mucus Score (University of California, San Francisco [UCSF] Mucus Scoring)
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at TLC
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Functional Residual Capacity (FRC)
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Trimmed Distal Specific Airway Resistance ([s]iRaw) at FRC
Time frame: Baseline (Day 1) to Week 24
Percent Change From Baseline to Week 24 in Global Lung Lobar Volumes (iVlobes) at TLC
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in HRCT-Based Internal Airflow Distribution (IAD) for Each Lung Zone
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Image-Based Ventilation/Perfusion (iV/Q) at TLC for Each Lung Zone
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in FeNO
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in Pre-Bronchodilator and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline (Day 1) to Week 24
Change From Baseline to Week 24 in 7 Item Asthma Control Questionnaire (ACQ-7)
Time frame: Baseline (Day 1) to Week 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events of Special Interest (AESIs)
Time frame: From first dose of study drug (Day 1) up to end of study (up to 36 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41145399Porsbjerg C, Dunican EM, Lugogo NL, Castro M, Papi A, Backer V, Brightling CE, Bourdin A, Virchow JC, Zhang M, Soler X, Rowe PJ, Deniz Y, de Prado Gomez L, Sacks HJ, Jacob-Nara JA. Effect of dupilumab on mucus burden in patients with moderate-to-severe asthma: the VESTIGE trial. Am J Respir Crit Care Med. 2026 Feb 1;212(2):241-252. doi: 10.1164/rccm.202410-1894OC.
- Derived from this study: PubMed 39947221Castro M, Papi A, Porsbjerg C, Lugogo NL, Brightling CE, Gonzalez-Barcala FJ, Bourdin A, Ostrovskyy M, Staevska M, Chou PC, Duca L, Pereira AM, Fogarty C, Nadama R, Zhang M, Rodrigues A, Soler X, Sacks HJ, Deniz Y, Rowe PJ, de Prado Gomez L, Jacob-Nara JA. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025 Mar;13(3):208-220. doi: 10.1016/S2213-2600(24)00362-X. Epub 2025 Feb 10.
- LPS15834 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 13 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 Sanofi at 65 sites in 13 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 9 inclusion and 31 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Bulgaria, United States, Romania, Saudi Arabia, Ukraine and 8 more countries. 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. Some participants in this study may receive a placebo. 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 10 Jul 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?
Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400318, which also lists 2 linked publications.
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 9 Sep 2025.