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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04456673




Registration number
NCT04456673
Ethics application status
Date submitted
30/06/2020
Date registered
2/07/2020
Date last updated
25/03/2024

Titles & IDs
Public title
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation
Scientific 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
Secondary ID [1] 0 0
U1111-1211-8837
Secondary ID [2] 0 0
EFC15805
Universal Trial Number (UTN)
Trial acronym
NOTUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab SAR231893
Treatment: Drugs - Inhaled Corticosteroid
Treatment: Drugs - Inhaled Long-Acting Beta Agonist
Treatment: Drugs - Inhaled Long-Acting Muscarinic Antagonist
Treatment: Drugs - Placebo

Experimental: Dupilumab - Dupilumab administered every 2 weeks

Placebo Comparator: Placebo - Placebo dose administered every 2 weeks


Treatment: Drugs: Dupilumab SAR231893
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous

Treatment: Drugs: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation

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

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

Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual rate of acute COPD exacerbation (AECOPD)
Timepoint [1] 0 0
Baseline to week 52
Secondary outcome [1] 0 0
Change in pre-bronchodilator FEV1
Timepoint [1] 0 0
Baseline to week 12
Secondary outcome [2] 0 0
Change in SGRQ
Timepoint [2] 0 0
Baseline to week 52
Secondary outcome [3] 0 0
Improvement in SGRQ
Timepoint [3] 0 0
Baseline to week 52
Secondary outcome [4] 0 0
Change in pre-bronchodilator FEV1 from baseline to Week 52
Timepoint [4] 0 0
Baseline to week 52
Secondary outcome [5] 0 0
Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44
Timepoint [5] 0 0
Baseline to weeks 2, 4, 8, 24, 36, 44
Secondary outcome [6] 0 0
Change in post-bronchodilator FEV1 lung function
Timepoint [6] 0 0
Baseline to weeks 2, 4, 8, 12, 24, 36, 52
Secondary outcome [7] 0 0
Change in forced expiratory flow (FEF) 25-75%
Timepoint [7] 0 0
Baseline to weeks 2, 4, 8, 12, 24, 36, 44, 52
Secondary outcome [8] 0 0
Annualized rate of severe AECOPD
Timepoint [8] 0 0
Baseline through week 52
Secondary outcome [9] 0 0
Time to first AECOPD
Timepoint [9] 0 0
Baseline through week 52
Secondary outcome [10] 0 0
Adverse events
Timepoint [10] 0 0
Baseline through week 64
Secondary outcome [11] 0 0
Potentially clinically significant abnormality (PCSA) in laboratory tests
Timepoint [11] 0 0
Baseline through week 64
Secondary outcome [12] 0 0
Anti-drug antibodies
Timepoint [12] 0 0
Baseline through week 64

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 a-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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/05/2024
Actual
Sample size
Target
Accrual to date
Final
935
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number : 0360008 - Kent Town
Recruitment hospital [2] 0 0
Investigational Site Number : 0360005 - Clayton
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Spearwood
Recruitment postcode(s) [1] 0 0
5067 - Kent Town
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment outside Australia
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Country [199] 0 0
United Kingdom
State/province [199] 0 0
Bristol
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Chippenham
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Derby

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT04456673
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04456673