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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

  • Clinicaltrials.gov identifier

    NCT03930732

  • Recruitment Status

    Recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    June 2, 2021

Study Description

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 and 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 anti-drug antibodies (ADA)

  • Condition or Disease:Chronic Obstructive Pulmonary Disease
  • Intervention/Treatment: Drug: Dupilumab SAR231893
    Drug: Inhaled Corticosteroid
    Drug: Inhaled Long-Acting Beta Agonist
    Drug: Inhaled Long-Acting Muscarinic Antagonist
    Drug: Placebo
  • Phase: Phase 3

Detailed Description

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

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 924 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official 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
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: January 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Dupilumab
Dupilumab administered every 2 weeks
Drug: Dupilumab SAR231893
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Drug: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

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

Drug: Inhaled Long-Acting Muscarinic Antagonist
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo Comparator: Placebo
Placebo dose administered every 2 weeks
Drug: Inhaled Corticosteroid
Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

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

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

Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Outcome Measures

  • Primary Outcome Measures: 1. Annual rate of acute COPD exacerbation (AECOPD) [ Time Frame: Baseline to Week 52 ]
    Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo
  • Secondary Outcome Measures: 1. Change in pre-bronchodilator FEV1 [ Time Frame: Baseline to Week 12 ]
    Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo
  • 2. Change in SGRQ [ Time Frame: Baseline to Week 52 ]
    Change from baseline to Week 52 in SGRQ total score compared to placebo
  • 3. Improvement in SGRQ [ Time Frame: Baseline to Week 52 ]
    Proportion of patients with SGRQ improvement ≥4 points at Week 52
  • 4. Change in pre-bronchodilator FEV1 from baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
    Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo
  • 5. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 [ Time Frame: Baseline to Weeks 2, 4, 8, 24, 36, 44 ]
    Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo
  • 6. Change in post-bronchodilator FEV1 lung function [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 24, 36, 52 ]
    Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo
  • 7. Change in forced expiratory flow (FEF) 25-75% [ Time Frame: Baseline to Weeks 2, 4, 8, 12, 24, 36, 44, 52 ]
    Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52
  • 8. Annualized rate of severe AECOPD [ Time Frame: Baseline through Week 52 ]
    Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period
  • 9. Time to first AECOPD [ Time Frame: Baseline through Week 52 ]
    Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period
  • 10. Adverse events [ Time Frame: Baseline through Week 64 ]
    Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)
  • 11. Potentially clinically significant abnormality (PCSA) in laboratory tests [ Time Frame: Baseline through Week 64 ]
    Percentage of patients with at least one incidence of PCSA
  • 12. Anti-drug antibodies [ Time Frame: Baseline to Week 64 ]
    Incidence of anti-drug antibodies against dupilumab

Eligibility Criteria

  • Ages Eligible for Study: 40 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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 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 acute exacerbation
of COPD (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.

- A current diagnosis of asthma or history of asthma according to the 2018 Global
Initiative for Asthma (GINA) guidelines or other accepted guidelines.

- 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.

- Treatment with oxygen of more than 12 hours per day.

- 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.

Contacts and Locations

Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations

United States, Alabama
Investigational Site Number 8400030
Andalusia

United States, Alabama
Investigational Site Number 8400041
Birmingham

United States, Alabama
Investigational Site Number 8400013
Birmingham

United States, Alabama
Investigational Site Number 8400059
Dothan

United States, Alabama
Investigational Site Number 8400057
Mobile

United States, Arizona
Investigational Site Number 8400043
Tucson

United States, Colorado
Investigational Site Number 8400034
Colorado Springs

United States, Florida
Investigational Site Number 8400010
Clearwater

United States, Florida
Investigational Site Number 8400014
Greenacres City

United States, Florida
Investigational Site Number 8400023
Miami

United States, Florida
Investigational Site Number 8400062
Miami

United States, Florida
Investigational Site Number 8400051
Ocala

United States, Florida
Investigational Site Number 8400029
Orlando

United States, Florida
Investigational Site Number 8400032
Panama City

United States, Florida
Investigational Site Number 8400026
Sarasota

United States, Georgia
Investigational Site Number 8400055
Dacula

United States, Georgia
Investigational Site Number 8400020
Decatur

United States, Georgia
Investigational Site Number 8400016
Marietta

United States, Georgia
Investigational Site Number 8400025
Woodstock

United States, Maryland
Investigational Site Number 8400038
White Marsh

United States, Michigan
Investigational Site Number 8400050
Ann Arbor

United States, Minnesota
Investigational Site Number 8400065
Rochester

United States, Mississippi
Investigational Site Number 8400071
Jackson

United States, Missouri
Investigational Site Number 8400011
Saint Charles

United States, Missouri
Investigational Site Number 8400004
Saint Louis

United States, Nevada
Investigational Site Number 8400035
Las Vegas

United States, New York
Investigational Site Number 8400067
Buffalo

United States, New York
Investigational Site Number 8400070
New York

United States, North Carolina
Investigational Site Number 8400019
Chapel Hill

United States, North Carolina
Investigational Site Number 8400061
Charlotte

United States, North Carolina
Investigational Site Number 8400064
Durham

United States, North Carolina
Investigational Site Number 8400052
Wilmington

United States, North Carolina
Investigational Site Number 8400060
Winston-Salem

United States, Ohio
Investigational Site Number 8400069
Cincinnati

United States, Ohio
Investigational Site Number 8400031
Cleveland

United States, Ohio
Investigational Site Number 8400040
Dayton

United States, Ohio
Investigational Site Number 8400024
Dublin

United States, Oklahoma
Investigational Site Number 8400005
Edmond

United States, Oregon
Investigational Site Number 8400001
Medford

United States, Pennsylvania
Investigational Site Number 8400037
Clairton

United States, Pennsylvania
Investigational Site Number 8400009
Philadelphia

United States, Pennsylvania
Investigational Site Number 8400033
Pittsburgh

United States, Pennsylvania
Investigational Site Number 8400063
Wyomissing

United States, South Carolina
Investigational Site Number 8400022
Easley

United States, South Carolina
Investigational Site Number 8400047
Gaffney

United States, South Carolina
Investigational Site Number 8400007
Greenville

United States, South Carolina
Investigational Site Number 8400044
Mount Pleasant

United States, South Carolina
Investigational Site Number 8400046
Rock Hill

United States, South Carolina
Investigational Site Number 8400048
Spartanburg

United States, Tennessee
Investigational Site Number 8400073
Franklin

United States, Texas
Investigational Site Number 8400002
Galveston

United States, Texas
Investigational Site Number 8400018
Houston

United States, Texas
Investigational Site Number 8400021
McKinney

United States, Texas
Investigational Site Number 8400027
Sherman

United States, Washington
Investigational Site Number 8400036
Tacoma

United States, Wisconsin
Investigational Site Number 8400008
Greenfield

Argentina
Investigational Site Number 0320001
Buenos Aires

Argentina
Investigational Site Number 0320005
Buenos Aires

Argentina
Investigational Site Number 0320002
Caba

Argentina
Investigational Site Number 0320003
Caba

Argentina
Investigational Site Number 0320004
Caba

Argentina
Investigational Site Number 0320008
Mar Del Plata

Argentina
Investigational Site Number 0320010
Mendoza

Argentina
Investigational Site Number 0320007
Quilmes

Argentina
Investigational Site Number 0320006
Rosario

Argentina
Investigational Site Number 0320009
San Miguel De Tucumán

Bulgaria
Investigational Site Number 1001004
Haskovo

Bulgaria
Investigational Site Number 1001003
Montana

Bulgaria
Investigational Site Number 1001006
Ruse

Bulgaria
Investigational Site Number 1001009
Sofia

Bulgaria
Investigational Site Number 1001002
Sofia

Bulgaria
Investigational Site Number 1001001
Sofia

Bulgaria
Investigational Site Number 1001005
Stara Zagora

Bulgaria
Investigational Site Number 1001010
Troyan

Canada
Investigational Site Number 1240002
Burlington

Canada
Investigational Site Number 1240021
Edmonton

Canada
Investigational Site Number 1240015
Edmonton

Canada
Investigational Site Number 1240009
Montreal

Canada
Investigational Site Number 1240003
Montreal

Canada
Investigational Site Number 1240001
Montreal

Canada
Investigational Site Number 1240005
Quebec

Canada
Investigational Site Number 1240004
Quebec

Canada
Investigational Site Number 1240019
Quebec

Canada
Investigational Site Number 1240018
Quebec

Canada
Investigational Site Number 1240014
Saskatoon

Canada
Investigational Site Number 1240010
Sherbrooke

Canada
Investigational Site Number 1240011
Sherbrooke

Canada
Investigational Site Number 1240016
Sherwood Park

Canada
Investigational Site Number 1240006
St-Charles Borrommee

Canada
Investigational Site Number 1240012
Toronto

Canada
Investigational Site Number 1240008
Trois-Rivieres

Canada
Investigational Site Number 1240017
Vancouver

Canada
Investigational Site Number 1240007
Vancouver

Canada
Investigational Site Number 1240020
Victoriaville

Canada
Investigational Site Number 1240013
Windsor

Chile
Investigational Site Number 1520006
Curicó

Chile
Investigational Site Number 1520004
Quillota

Chile
Investigational Site Number 1520009
Santiago

Chile
Investigational Site Number 1520003
Santiago

Chile
Investigational Site Number 1520005
Santiago

Chile
Investigational Site Number 1520008
Santiago

Chile
Investigational Site Number 1520002
Santiago

Chile
Investigational Site Number 1520001
Talca

China
Investigational Site Number 1560037
Baotou

China
Investigational Site Number 1560006
Beijing

China
Investigational Site Number 1560003
Changchun

China
Investigational Site Number 1560022
Changsha

China
Investigational Site Number 1560021
Changsha

China
Investigational Site Number 1560001
Chengdu

China
Investigational Site Number 1560017
Chengdu

China
Investigational Site Number 1560012
Chongqing

China
Investigational Site Number 1560005
Chongqing

China
Investigational Site Number 1560019
Guangzhou

China
Investigational Site Number 1560036
Guangzhou

China
Investigational Site Number 1560018
Haikou

China
Investigational Site Number 1560046
Hangzhou

China
Investigational Site Number 1560009
Hefei

China
Investigational Site Number 1560041
Hefei

China
Investigational Site Number 1560015
Hohhot

China
Investigational Site Number 1560008
Hohhot

China
Investigational Site Number 1560027
Nanchang

China
Investigational Site Number 1560034
Nanjing

China
Investigational Site Number 1560032
Shanghai

China
Investigational Site Number 1560013
Shanghai

China
Investigational Site Number 1560007
Shanghai

China
Investigational Site Number 1560014
Shenyang

China
Investigational Site Number 1560004
Shenyang

China
Investigational Site Number 1560051
Shenzhen

China
Investigational Site Number 1560016
Shijiazhuang

China
Investigational Site Number 1560024
Taiyuan

China
Investigational Site Number 1560010
Tianjin

China
Investigational Site Number 1560028
Urumchi

China
Investigational Site Number 1560020
Xi'An

China
Investigational Site Number 1560054
Xuzhou

China
Investigational Site Number 1560011
Yangzhou

China
Investigational Site Number 1560047
Yinchuan

China
Investigational Site Number 1560002
Zhengzhou

Czechia
Investigational Site Number 2030002
Jindrichuv Hradec III

Czechia
Investigational Site Number 2030005
Karlovy Vary

Czechia
Investigational Site Number 2030009
Miroslav

Czechia
Investigational Site Number 2030001
Novy Bor

Czechia
Investigational Site Number 2030003
Praha 4

Czechia
Investigational Site Number 2030008
Praha 6 - Brevnov

Czechia
Investigational Site Number 2030004
Rokycany

Czechia
Investigational Site Number 2030006
Strakonice

Denmark
Investigational Site Number 2080001
Copenhagen Nv

Denmark
Investigational Site Number 2080008
Hellerup

Denmark
Investigational Site Number 2080002
Hvidovre

Denmark
Investigational Site Number 2080006
Naestved

Denmark
Investigational Site Number 2080005
Odense C

Denmark
Investigational Site Number 2080004
Roskilde

Denmark
Investigational Site Number 2080007
Vejle

Denmark
Investigational Site Number 2080003
Ålborg

Finland
Investigational Site Number 2460003
Pori

Finland
Investigational Site Number 2460002
Tampere

Finland
Investigational Site Number 2460001
Turku

Germany
Investigational Site Number 2760006
Berlin

Germany
Investigational Site Number 2760009
Frankfurt Am Main

Germany
Investigational Site Number 2760002
Hamburg

Germany
Investigational Site Number 2760007
Koblenz

Germany
Investigational Site Number 2760011
Leipzig

Germany
Investigational Site Number 2760010
Lübeck

Germany
Investigational Site Number 2760008
Marburg

Hungary
Investigational Site Number 3480007
Balassagyarmat

Hungary
Investigational Site Number 3480011
Budapest

Hungary
Investigational Site Number 3480008
Edelény

Hungary
Investigational Site Number 3480001
Gödöllö

Hungary
Investigational Site Number 3480010
Hajdunánás

Hungary
Investigational Site Number 3480002
Komarom

Hungary
Investigational Site Number 3480003
Makó

Hungary
Investigational Site Number 3480006
Mohács

Hungary
Investigational Site Number 3480012
Püspökladány

Hungary
Investigational Site Number 3480005
Szombathely

Hungary
Investigational Site Number 3480004
Százhalombatta

Israel
Investigational Site Number 3760006
Ashkelon

Israel
Investigational Site Number 3760007
Beer Sheva

Israel
Investigational Site Number 3760003
Haifa

Israel
Investigational Site Number 3760005
Jerusalem

Israel
Investigational Site Number 3760004
Jerusalem

Israel
Investigational Site Number 3760001
Petah-Tikva

Israel
Investigational Site Number 3760002
Rehovot

Italy
Investigational Site Number 3800006
Bologna

Italy
Investigational Site Number 3800002
Catania

Italy
Investigational Site Number 3800004
Cona

Italy
Investigational Site Number 3800007
Pisa

Italy
Investigational Site Number 3800001
Reggio Emilia

Italy
Investigational Site Number 3800005
Roma

Italy
Investigational Site Number 3800003
Rozzano

Japan
Investigational Site Number 3920005
Chuo-Ku

Japan
Investigational Site Number 3920008
Chuo-Ku

Japan
Investigational Site Number 3920030
Chuo-Ku

Japan
Investigational Site Number 3920021
Hamamatsu-Shi

Japan
Investigational Site Number 3920023
Higashiibaraki-Gun

Japan
Investigational Site Number 3920011
Himeji-Shi

Japan
Investigational Site Number 3920003
Joyo-Shi

Japan
Investigational Site Number 3920013
Kasuga-Shi

Japan
Investigational Site Number 3920018
Kawachinagano-Shi

Japan
Investigational Site Number 3920001
Kishiwada-Shi

Japan
Investigational Site Number 3920015
Kokubunji-Shi

Japan
Investigational Site Number 3920017
Kyoto-Shi

Japan
Investigational Site Number 3920014
Naka-Gun

Japan
Investigational Site Number 3920028
Osaka-Shi

Japan
Investigational Site Number 3920012
Sakai-Shi

Japan
Investigational Site Number 3920016
Shinagawa-Ku

Japan
Investigational Site Number 3920019
Takamatsu-Shi

Japan
Investigational Site Number 3920004
Toshima-Ku

Japan
Investigational Site Number 3920026
Toshima-Ku

Japan
Investigational Site Number 3920006
Ueda-Shi

Japan
Investigational Site Number 3920029
Urasoe-Shi

Japan
Investigational Site Number 3920027
Yokohama-Shi

Korea, Republic of
Investigational Site Number 4100008
Incheon

Korea, Republic of
Investigational Site Number 4100004
Seongnam-Si

Korea, Republic of
Investigational Site Number 4100005
Seoul

Korea, Republic of
Investigational Site Number 4100001
Seoul

Korea, Republic of
Investigational Site Number 4100009
Seoul

Korea, Republic of
Investigational Site Number 4100006
Seoul

Korea, Republic of
Investigational Site Number 4100007
Seoul

Korea, Republic of
Investigational Site Number 4100003
Wonju

Mexico
Investigational Site Number 4840004
Chihuahua

Mexico
Investigational Site Number 4840003
Durango

Mexico
Investigational Site Number 4840002
Guadalajara

Mexico
Investigational Site Number 4840006
Mexico Distrito Federal

Mexico
Investigational Site Number 4840001
Monterrey

Mexico
Investigational Site Number 4840007
Oaxaca

Mexico
Investigational Site Number 4840005
Veracruz

Poland
Investigational Site Number 6160008
Bialystok

Poland
Investigational Site Number 6160014
Elblag

Poland
Investigational Site Number 6160015
Grodzisk Mazowiecki

Poland
Investigational Site Number 6160009
Grudziadz

Poland
Investigational Site Number 6160011
Katowice

Poland
Investigational Site Number 6160007
Krakow

Poland
Investigational Site Number 6160016
Poznan

Poland
Investigational Site Number 6160006
Poznan

Poland
Investigational Site Number 6160012
Warszawa

Romania
Investigational Site Number 6420001
Bucharest

Romania
Investigational Site Number 6420009
Bucuresti

Romania
Investigational Site Number 6420008
Bucuresti

Romania
Investigational Site Number 6420003
Cluj-Napoca

Romania
Investigational Site Number 6420004
Cluj-Napoca

Romania
Investigational Site Number 6420007
Constanta

Romania
Investigational Site Number 6420006
Timisoara

Romania
Investigational Site Number 6420010
Timisoara

Russian Federation
Investigational Site Number 6430003
Chelyabinsk

Russian Federation
Investigational Site Number 6430004
Kazan

Russian Federation
Investigational Site Number 6430006
Moscow

Russian Federation
Investigational Site Number 6430001
Moscow

Russian Federation
Investigational Site Number 6430005
Moscow

Russian Federation
Investigational Site Number 6430008
Moscow

Russian Federation
Investigational Site Number 6430002
Moscow

Russian Federation
Investigational Site Number 6430009
Moscow

Russian Federation
Investigational Site Number 6430007
St-Petersburg

Slovakia
Investigational Site Number 7030007
Banska Bystrica

Slovakia
Investigational Site Number 7030006
Humenne

Slovakia
Investigational Site Number 7030003
Levice

Slovakia
Investigational Site Number 7030001
Poprad

Slovakia
Investigational Site Number 7030002
Spisska Nova Ves

Spain
Investigational Site Number 7240002
Barcelona

Spain
Investigational Site Number 7240003
Madrid

Spain
Investigational Site Number 7240001
Málaga

Spain
Investigational Site Number 7240005
Mérida

Spain
Investigational Site Number 7240010
Palma De Mallorca

Spain
Investigational Site Number 7240006
Pozuelo De Alarcón

Spain
Investigational Site Number 7240007
Sant Boi De Llobregat

Spain
Investigational Site Number 7240096
Santiago De Compostela

Spain
Investigational Site Number 7240004
Valencia

Sweden
Investigational Site Number 7520001
Lund

Sweden
Investigational Site Number 7520002
Stockholm

Sweden
Investigational Site Number 7520003
Örebro

Turkey
Investigational Site Number 7920004
Ankara

Turkey
Investigational Site Number 7920001
Istanbul

Turkey
Investigational Site Number 7920006
Izmir

Turkey
Investigational Site Number 7920007
Izmir

Turkey
Investigational Site Number 7920008
Kirikkale

Turkey
Investigational Site Number 7920005
Manisa

Turkey
Investigational Site Number 7920002
Mersin

Ukraine
Investigational Site Number 8040003
Chernivtsi

Ukraine
Investigational Site Number 8040001
Ivano-Frankivsk

Ukraine
Investigational Site Number 8040006
Kharkiv

Ukraine
Investigational Site Number 8040004
Kyiv

Ukraine
Investigational Site Number 8040009
Odesa

Ukraine
Investigational Site Number 8040002
Ternopil

Ukraine
Investigational Site Number 8040005
Vinnytsya

Ukraine
Investigational Site Number 8040007
Zhytomyr

Sponsors and Collaborators

Sanofi

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Sciences & Operations Sanofi

More Information

  • Responsible Party: Sanofi
  • ClinicalTrials.gov Identifier: NCT03930732 History of Changes
  • Other Study ID Numbers: EFC15804, 2018-001953-28, U1111-1211-8804
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: June 2, 2021
  • Last Verified: June 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: 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://www.clinicalstudydatarequest.com/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Inflammation