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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03546907
Ethics application status
Date submitted
17/05/2018
Date registered
6/06/2018

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 - SAR440340
Treatment: Drugs - Placebo
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

Placebo comparator: Placebo - Participants received placebo matched to SAR440340 administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W). Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, End of Treatment (EOT) visit occurred 2 weeks after last administration of IMP i.e., at Week 52).

Experimental: SAR440340 - Participants received SAR440340 300 milligrams (mg) administered as 2 SC injections Q2W. Participants were treated for a minimum of 24 weeks and up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of IMP i.e., at Week 52).


Treatment: Drugs: SAR440340
Pharmaceutical form: Solution for injection; Route of administration: SC

Treatment: Drugs: Placebo
Pharmaceutical form: Solution for injection; Route of administration: SC

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
Annualized Rate of Moderate to Severe Acute Exacerbation Events in Chronic Obstructive Pulmonary Disease (AECOPD) Participants
Timepoint [1] 0 0
From Baseline up to Week 52
Secondary outcome [1] 0 0
Average Change in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Week 16 Through Week 24
Timepoint [1] 0 0
From Baseline to Week 16 through Week 24
Secondary outcome [2] 0 0
Change From Baseline in Post-bronchodilator Forced Expiratory Volume (FEV1) in 1 Second at Week 24
Timepoint [2] 0 0
Baseline, Week 24
Secondary outcome [3] 0 0
Time to First Moderate or Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
Timepoint [3] 0 0
From Baseline up to 52 weeks

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] less than [<] 70 percent (%) and post-bronchodilator FEV1% predicted <80%, but greater than equal to [>=] 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 participant in whom other causes of chronic cough [e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis] had been excluded).
* Participants with a documented history (e.g., medical record verification) of >=2 moderate exacerbations or >=1 severe exacerbation within the year prior to screening. A moderate exacerbation was 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 was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were 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 intravenous 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 (greater than [>] 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 was not intended to contain all considerations relevant to a participant'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
16/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2020
Sample size
Target
Accrual to date
Final
343
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
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
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
Saint-Charles-Borromée
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
State/province [24] 0 0
Quillota
Country [25] 0 0
Chile
State/province [25] 0 0
Santiago
Country [26] 0 0
Chile
State/province [26] 0 0
Talcahuano
Country [27] 0 0
Chile
State/province [27] 0 0
Talca
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Großhansdorf
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Koblenz
Country [32] 0 0
Germany
State/province [32] 0 0
München
Country [33] 0 0
Germany
State/province [33] 0 0
Rüdersdorf Bei Berlin
Country [34] 0 0
Poland
State/province [34] 0 0
Bialystok
Country [35] 0 0
Poland
State/province [35] 0 0
Bydgoszcz
Country [36] 0 0
Poland
State/province [36] 0 0
Grudziadz
Country [37] 0 0
Poland
State/province [37] 0 0
Krakow
Country [38] 0 0
Poland
State/province [38] 0 0
Poznan
Country [39] 0 0
Poland
State/province [39] 0 0
Rzeszow
Country [40] 0 0
Poland
State/province [40] 0 0
Znin
Country [41] 0 0
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
Country [47] 0 0
Turkey
State/province [47] 0 0
Istanbul
Country [48] 0 0
Turkey
State/province [48] 0 0
Izmir
Country [49] 0 0
Turkey
State/province [49] 0 0
Kirikkale
Country [50] 0 0
Turkey
State/province [50] 0 0
Mersin
Country [51] 0 0
Ukraine
State/province [51] 0 0
Chernivtsi
Country [52] 0 0
Ukraine
State/province [52] 0 0
Ivano-Frankivsk
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kharkiv
Country [54] 0 0
Ukraine
State/province [54] 0 0
Kyiv
Country [55] 0 0
Ukraine
State/province [55] 0 0
Odesa
Country [56] 0 0
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
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03546907