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 (NOTUS)

  • STATUS
    Recruiting
  • End date
    Oct 20, 2023
  • participants needed
    924
  • sponsor
    Sanofi
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Updated on 25 October 2022
See if I qualify
corticosteroids
pulmonary function test
bronchitis
dyspnea
cough
bronchodilator
forced expiratory volume
eosinophil count
muscarinic antagonists
severe chronic obstructive pulmonary disease
copd exacerbation

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 or 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 antidrug antibodies (ADA)

Description

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

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Placebo, Inhaled Corticosteroid, Dupilumab SAR231893, Inhaled Long-Acting Beta Agonist, Inhaled Long-Acting Muscarinic Antagonist
Clinical Study IdentifierNCT04456673
SponsorSanofi
Last Modified on25 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Inclusion criteria
Participants with a physician diagnosis of COPD who meet the following criteria at
screening
Current or former smokers with a smoking history of ≥10 pack-years
Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%)
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
Medical Research Council (MRC) Dyspnea Scale grade ≥2
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 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
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
Exclusion criteria
Cor pulmonale, evidence of right cardiac failure
Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma
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
Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%
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
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