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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03546907




Registration number
NCT03546907
Ethics application status
Date submitted
17/05/2018
Date registered
6/06/2018
Date last updated
28/02/2020

Titles & IDs
Public title
Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
2017-003290-34
Secondary ID [2] 0 0
ACT15104
Universal Trial Number (UTN)
Trial acronym
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 - Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
Treatment: Drugs - Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
Treatment: Drugs - Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
Treatment: Drugs - Any short-acting ß agonist as prescribed by treating physician as standard of care

Experimental: SAR440340 - Administration of SAR440340 monotherapy injection

Placebo Comparator: Placebo - Administration of matching placebo for injection of SAR440340


Treatment: Drugs: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care
Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled

Treatment: Drugs: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care
Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled

Treatment: Drugs: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care
Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled

Treatment: Drugs: Any short-acting ß agonist as prescribed by treating physician as standard of care
Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: inhaled

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of moderate-to-severe acute Exacerbations in chronic obstructive pulmonary disease (AECOPD) patients - Annualized rate of moderate-to-severe AECOPD over up to 52 weeks.
Timepoint [1] 0 0
Over up to 52 weeks treatment period
Secondary outcome [1] 0 0
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) - Average change in pre-bronchodilator FEV1 from Week 16 to Week 24.
Timepoint [1] 0 0
Baseline to Week 16-24
Secondary outcome [2] 0 0
Time to first COPD Exacerbation - Time to first moderate or severe AECOPD.
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
Adverse Events - Monitor treatment emergent adverse events and serious adverse events.
Timepoint [3] 0 0
Screening up to 72 weeks
Secondary outcome [4] 0 0
Change in post-bronchodilator FEV1 - Change from baseline to Week 24 in FEV1 (post-bronchodilator).
Timepoint [4] 0 0
Baseline to Week 24

Eligibility
Key inclusion criteria
Inclusion criteria :

- Participants with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at
least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD]
definition.

- Participants with moderate-to-severe COPD (post-bronchodilator Forced Expiratory
Volume in 1 Second [FEV1]/forced vital capacity [FVC] <70% and post-bronchodilator
FEV1 % predicted <80%, but =30%).

- Participants with COPD Assessment Test (CAT) score =10 at Screening

- Participants with reported history of signs and symptoms of chronic bronchitis
(chronic productive cough for 3 months in the year up to screening in a patient in
whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic
rhinosinusitis, bronchiectasis] have been excluded).

- Participants with a documented history (eg. medical record verification) of =2
moderate exacerbations or =1 severe exacerbation within the year prior to screening. A
moderate exacerbation is defined as an acute exacerbation of COPD (AECOPD) requiring
systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with
antibiotics (however, use of antibiotics alone does not qualify as a "moderate
exacerbation" unless documentation is available that use of antibiotics was necessary
for treatment of worsening symptoms of COPD). A severe exacerbation is defined as an
AECOPD that required a hospitalization.

- Participants with Standard of Care background therapy, for 3 months and at a stable
dose for at least 1 month, including either:

- Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist
(LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.

or

- Triple therapy: LABA + LAMA +ICS.

- Current or former smokers with a smoking history of =10 packs/year.
Minimum age
40 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Concomitant severe diseases or diseases for which the use of Inhaled Corticosteroids
(ICS) (e.g., active pulmonary tuberculosis, etc.) or Long Acting Beta Agonists (LABA)
are contraindicated (e.g., diagnosis of a history of significant cardiovascular
diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis,
pheochromocytoma, hypokalemia).

- Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within
previous 1 month or more than 4 courses of IV glucocorticosteroids within the previous
6 months

- Participants with Bronchial thermoplasty procedure (up to 3 years prior to Visit 1)

- A current diagnosis of asthma according to the Global Initiative for Asthma (GINA)
guidelines.

- Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis,
interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic
granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway
Pressure, etc) or another diagnosed pulmonary or systemic disease associated with
elevated peripheral eosinophil counts.

- Diagnosis of a-1 anti-trypsin deficiency.

- Advanced COPD with need for chronic (>15 hours/day) oxygen support.

- Participant with a moderate or severe Acute Exacerbation of COPD event within previous
4 weeks

- A participant who has experienced an upper or lower respiratory tract infection within
previous 4 weeks

- Prior history of or planned pneumonectomy or lung volume reduction surgery.

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 0360005 - Bedford Park
Recruitment hospital [2] 0 0
Investigational Site Number 0360002 - Chermside
Recruitment hospital [3] 0 0
Investigational Site Number 0360004 - Clayton
Recruitment hospital [4] 0 0
Investigational Site Number 0360003 - Frankston
Recruitment hospital [5] 0 0
Investigational Site Number 0360006 - Kent Town
Recruitment hospital [6] 0 0
Investigational Site Number 0360001 - Murdoch
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
5067 - Kent Town
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
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Maryland
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United States of America
State/province [4] 0 0
Massachusetts
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United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
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New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Argentina
State/province [14] 0 0
Quilmes
Country [15] 0 0
Argentina
State/province [15] 0 0
Rosario
Country [16] 0 0
Canada
State/province [16] 0 0
Burlington
Country [17] 0 0
Canada
State/province [17] 0 0
Hamilton
Country [18] 0 0
Canada
State/province [18] 0 0
Montreal
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
St-Charles Borrommee
Country [21] 0 0
Canada
State/province [21] 0 0
Trois-Rivieres
Country [22] 0 0
Canada
State/province [22] 0 0
Vancouver
Country [23] 0 0
Canada
State/province [23] 0 0
Victoriaville
Country [24] 0 0
Chile
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Quillota
Country [25] 0 0
Chile
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Santiago
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Chile
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Talcahuano
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Chile
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Talca
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Germany
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Berlin
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Germany
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Großhansdorf
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Germany
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Hamburg
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Germany
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Koblenz
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Germany
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München
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Germany
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Rüdersdorf Bei Berlin
Country [34] 0 0
Poland
State/province [34] 0 0
Bialystok
Country [35] 0 0
Poland
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Bydgoszcz
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Poland
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Grudziadz
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Rzeszow
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Poland
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Znin
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Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saint-Petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
St-Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Stavropol
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Ulyanovsk
Country [46] 0 0
Turkey
State/province [46] 0 0
Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kirikkale
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Turkey
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Mersin
Country [51] 0 0
Ukraine
State/province [51] 0 0
Chernivtsi
Country [52] 0 0
Ukraine
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Ivano-Frankivsk
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kharkiv
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Ukraine
State/province [54] 0 0
Kyiv
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Ukraine
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Odesa
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Ukraine
State/province [56] 0 0
Ternopil
Country [57] 0 0
Ukraine
State/province [57] 0 0
Vinnytsya

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 investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb])
compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of
COPD (AECOPD) over up to 52 weeks of treatment.

- Moderate exacerbations are recorded by the Investigator and defined as AECOPD that
require either systemic corticosteroids (such as intramuscular, intravenous or oral)
and/or antibiotics.

- Severe exacerbations are recorded by the Investigator and defined as AECOPD requiring
hospitalization, emergency medical care visit or resulting in death.

Secondary Objectives:

To investigate effects of SAR440340 compared with placebo, on improving respiratory function,
as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1).

To evaluate effects of SAR440340 compared with placebo, on Post-bronchodilator FEV1.

To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first
moderate or severe AECOPD event.

To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.
Trial website
https://clinicaltrials.gov/show/NCT03546907
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
Other publications