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Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation (NOTUS)

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Sanofi

Status and phase

Active, not recruiting
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Placebo
Drug: Inhaled Long-Acting Muscarinic Antagonist
Drug: Inhaled Corticosteroid
Drug: Inhaled Long-Acting Beta Agonist
Drug: Dupilumab SAR231893

Study type

Interventional

Funder types

Industry

Identifiers

NCT04456673
EFC15805
U1111-1211-8837 (Other Identifier)
2018-001954-91 (EudraCT Number)

Details and patient eligibility

About

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)

Full description

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

Enrollment

935 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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%).
  • 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 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.
  • Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.
  • 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.
  • 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%
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

935 participants in 2 patient groups, including a placebo group

Dupilumab
Experimental group
Description:
Dupilumab administered every 2 weeks
Treatment:
Drug: Dupilumab SAR231893
Drug: Inhaled Long-Acting Beta Agonist
Drug: Inhaled Corticosteroid
Drug: Inhaled Long-Acting Muscarinic Antagonist
Placebo
Placebo Comparator group
Description:
Placebo dose administered every 2 weeks
Treatment:
Drug: Inhaled Long-Acting Beta Agonist
Drug: Inhaled Corticosteroid
Drug: Inhaled Long-Acting Muscarinic Antagonist
Drug: Placebo

Trial contacts and locations

335

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Data sourced from clinicaltrials.gov

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