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Trial record 1 of 1 for:    LPS16676
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Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

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ClinicalTrials.gov Identifier: NCT05097287
Recruitment Status : Recruiting
First Posted : October 28, 2021
Last Update Posted : January 31, 2024
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.

The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.


Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1828 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : June 28, 2025
Estimated Study Completion Date : January 18, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
Dupilumab administered every 2 weeks (Q2W) after an initial loading dose (2 injections) on Day 1
Drug: Dupilumab
solution for injection subcutaneous

Placebo Comparator: Placebo
Matching placebo administered Q2W after an initial loading dose (2 injections) on Day 1
Drug: Placebo
solution for injection subcutaneous




Primary Outcome Measures :
  1. Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population [ Time Frame: Week 8 to Week 52 ]
    Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.


Secondary Outcome Measures :
  1. Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population [ Time Frame: Week 8 to Week 52 ]
    Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.

  2. Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population [ Time Frame: Week 8 to Week 104 ]
    Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.

  3. Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.

  4. Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.

  5. Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

  6. Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Change from baseline to week 52 in FeNO levels in FeNO and Total populations.

  7. Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.

  8. Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.

  9. Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    Change from baseline to week 52 in FVC in FeNO and Total populations.

  10. Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population [ Time Frame: Week 8 to Week 104 ]
    Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.

  11. Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.

  12. Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.

  13. Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

  14. Change from baseline to week 104 in FeNO levels in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Change from baseline to week 104 in FeNO levels in FeNO and Total populations.

  15. Change from baseline to week 104 in ACQ-7 in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.

  16. Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.

  17. Change from baseline to week 104 FVC in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    Change from baseline to week 104 FVC in FeNO and Total populations.

  18. Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations [ Time Frame: Baseline to Week 52 ]
    The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.

  19. Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations [ Time Frame: Baseline to Week 104 ]
    The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.

  20. Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations [ Time Frame: Week 8 to Week 156 ]
    Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.

  21. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) [ Time Frame: Baseline to Week 168 ]
    Incidence of TEAEs and SAEs.

  22. Incidence of adverse events of special interest (AESIs) [ Time Frame: Baseline to Week 168 ]
    Incidence of AESIs.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be at least 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age inclusive, at the time of signing the informed consent.

    • Patients with a physician diagnosis of asthma (according to Global Initiative for Asthma (GINA) 2021) for ≥12 months
    • Treatment with medium to high dose inhaled corticosteroids (ICS) (≥250 mcg of fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a second controller (eg, long-acting beta-2 adrenergic receptor agonists (LABA), LTRA) with a stable dose ≥1 month prior to Visit 1. Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be on stable dose ≥1 month prior to Visit 1.
    • Pre-bronchodilator forced expiratory volume (FEV1) ≤ 80% of predicted normal for adults at Visits 1 and 2, prior to randomization
    • Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at Visits 1 and 2, prior to randomization.
    • Bronchodilator reversibility (≥ 12% and 200 mL improvement in FEV1 post short-acting beta agonists (SABA) administration) during the screening period, prior to randomization, unless reversibility test meeting the inclusion criteria was done within 12 months prior to Visit 1.
    • FeNO ≥35 ppb at Visit 2, prior to randomization. Up to 550 patients can be enrolled with baseline FeNO<35 ppb at Visit 2
    • History of ≥1 severe exacerbation(s) in the previous year before V1 defined as a deterioration of asthma requiring:
  • Use of systemic corticosteroids for ≥3 days; or
  • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. - - - -

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, emphysema, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome).
  • Severe asthma exacerbation requiring treatment with systemic corticosteroid (SCS) in the past month before visit 1 or during the screening period.
  • Current acute bronchospasm or status asthmaticus.
  • Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts.
  • Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. Examples include, but are not limited to, participants with short life expectancy, uncontrolled diabetes, cardiovascular conditions, severe renal conditions (eg, participants on dialysis), or other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric, or lymphatic diseases. The specific justification for participants excluded under this criterion will be noted in the study documents (chart notes, case report forms [CRFs], etc).
  • Patients with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing will be performed on a country by country basis, according to local guidelines if required by regulatory authorities or ethics boards, or if TB is suspected by the investigator
  • Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune-compromised status, as judged by the Investigator.
  • Active malignancy or history of malignancy within 5 years before Visit 1 (screening visit), except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or receiving only symptomatic treatment (e.g. influenza or COVID-19) within 2 weeks before the screening visit (Visit 1) or during the screening period.
  • History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Visit 1 (screening visit).
  • Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drugs within 2 weeks before Visit 1 (screening visit) or during the screening and run-in period
  • Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months prior to Visit 1.
  • Previous smoker with a smoking history >10 pack-years.
  • History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy, including any excipient.
  • Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks prior to V1 or 5 half-lives, whichever is longer.
  • Treatment with a live (attenuated) vaccine within 4 weeks before Visit 1 (screening visit) or during the screening period.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097287


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Additional Information:
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT05097287    
Other Study ID Numbers: LPS16676
U1111-1266-2849 ( Registry Identifier: ICTRP )
2021-003903-16 ( EudraCT Number )
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases