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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

Clinicaltrials.gov identifier NCT03930732

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted September 29, 2020

Study Description

Brief summary:

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

  • Condition or Disease:Chronic Obstructive Pulmonary Disease
  • Intervention/Treatment: Drug: Dupilumab SAR231893
    Drug: Inhaled Corticosteroid
    Drug: Inhaled Long-Acting Beta Agonist
    Drug: Inhaled Long-Acting Muscarinic Antagonist
    Drug: Placebo
  • Phase: Phase 3
Detailed Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 924 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, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: September 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Dupilumab
Dupilumab administered every 2 weeks
Drug: Dupilumab SAR231893
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Drug: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Drug: Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Drug: Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo Comparator: Placebo
Placebo dose administered every 2 weeks
Drug: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Drug: Inhaled Long-Acting Beta Agonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Drug: Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Outcome Measures
  • Primary Outcome Measures: 1. Annual rate of acute COPD exacerbation (AECOPD) [ Time Frame: Baseline to Week 52 ]
    Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo
  • Secondary Outcome Measures: 1. Anti-drug antibodies [ Time Frame: Baseline to Week 64 ]
    Incidence of anti-drug antibodies against dupilumab
  • 2. Change in pre-bronchodilator FEV1 [ Time Frame: Baseline to Week 12 ]
    Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
  • 3. Change in SGRQ [ Time Frame: Baseline to Week 52 ]
    Change from baseline to Week 52 in SGRQ total score compared to placebo
  • 4. Improvement in SGRQ [ Time Frame: Baseline to Week 52 ]
    Proportion of patients with SGRQ improvement ≥4 points at Week 52
  • 5. Change in pre-bronchodilator FEV1 from baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
    Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
  • 6. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 48 [ Time Frame: Baseline to Weeks 2, 4, 8, 16, 20, 24, 28, 36, 44, 48 ]
    Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 16, 20, 24, 28, 36, 44 and 48) compared to placebo
  • 7. Change in post-bronchodilator FEV1 lung function [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 24, 36, 52 ]
    Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
  • 8. Change in forced expiratory flow (FEF) 25-75% [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 16, 24, 28, 36, 44, 52 ]
    Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 16, 24, 28, 36, 44 and 52
  • 9. Annualized rate of severe AECOPD [ Time Frame: Baseline through Week 52 ]
    Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
  • 10. Time to first AECOPD [ Time Frame: Baseline through Week 52 ]
    Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
  • 11. Adverse events [ Time Frame: Baseline through Week 64 ]
    Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)
  • 12. Potentially clinically significant abnormality (PCSA) in laboratory tests [ Time Frame: Baseline through Week 64 ]
    Percentage of patients with at least one incidence of PCSA
Eligibility Criteria
  • Ages Eligible for Study: 40 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion criteria:

- Participants with a physician diagnosis of COPD who meet the following criteria:

- Current or former smokers with a smoking history of ≥10 pack-years.

- Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC]
≤70% and post-bronchodilator FEV1 % predicted >30% and ≤70%).

- Medical Research Council (MRC) Dyspnea Scale grade ≥2.

- Patient-reported history of signs and symptoms of chronic bronchitis (chronic
productive cough) for 3 months in the year up to screening in the absence of
other known causes of chronic cough.

- Documented history of high exacerbation risk defined as exacerbation history of
≥2 moderate or ≥1 severe within the year prior to inclusion. At least one
exacerbation should have occurred while the patient was taking inhaled
corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic
antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate
exacerbations are recorded by the investigator and defined as acute exacerbation
of COPD (AECOPD) that require either systemic corticosteroids (intramuscular,
intravenous, or oral) and/or antibiotics. One of the two required moderate
exacerbations has to require the use of systemic corticosteroids. Severe
exacerbations are recorded by the investigator and defined as AECOPD requiring
hospitalization or observation >24 hours in emergency department/urgent care
facility.

- Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization
with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy
(LABA + LAMA) allowed if ICS is contraindicated.

- Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter
at Visit 1.

Exclusion criteria:

- COPD diagnosis for less than 12 months prior to randomization.

- A current diagnosis of asthma or history of asthma according to the 2018 Global
Initiative for Asthma (GINA) guidelines or other accepted guidelines.

- Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis,
interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss
Syndrome etc) or another diagnosed pulmonary or systemic disease associated with
elevated peripheral eosinophil counts.

- Cor pulmonale, evidence of right cardiac failure.

- Treatment with oxygen of more than 12 hours per day.

- Hypercapnia requiring Bi-level ventilation.

- AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during
the screening period.

- Respiratory tract infection within 4 weeks prior to screening, or during the screening
period.

- History of, or planned pneumonectomy or lung volume reduction surgery. Patients who
are participating in the acute phase of a pulmonary rehabilitation program, ie, who
started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included). - Diagnosis of α-1 anti-trypsin deficiency. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations
Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
Show 275 Study Locations
Sponsors and Collaborators

Sanofi

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Sciences & Operations Sanofi

More Information
  • Responsible Party: Sanofi
  • ClinicalTrials.gov Identifier: NCT03930732 History of Changes
  • Other Study ID Numbers: EFC15804, 2018-001953-28, U1111-1211-8804
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: September 29, 2020
  • Last Verified: September 2020
  • 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://www.clinicalstudydatarequest.com/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Inflammation