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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04456673
Ethics application status
Date submitted
30/06/2020
Date registered
2/07/2020

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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United States of America
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04456673