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)

PHASE2CompletedINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

July 16, 2018

Primary Completion Date

October 3, 2019

Study Completion Date

February 21, 2020

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

SAR440340

Pharmaceutical form: Solution for injection; Route of administration: SC

DRUG

Placebo

Pharmaceutical form: Solution for injection; Route of administration: SC

DRUG

Any Inhaled Corticosteroids as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled

DRUG

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

DRUG

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

DRUG

Any short-acting β agonist as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled

Trial Locations (83)

2000

Investigational Site Number 0320003, Rosario

3168

Investigational Site Number 0360004, Clayton

3199

Investigational Site Number 0360003, Frankston

4032

Investigational Site Number 0360002, Chermside

5042

Investigational Site Number 0360005, Bedford Park

5067

Investigational Site Number 0360006, Kent Town

6150

Investigational Site Number 0360001, Murdoch

10787

Investigational Site Number 2760006, Berlin

15562

Investigational Site Number 2760005, Rüdersdorf Bei Berlin

19140

Investigational Site Number 8400009, Philadelphia

20354

Investigational Site Number 2760002, Hamburg

21001

Investigational Site Number 8040005, Vinnytsia

21044

Investigational Site Number 8400012, Columbia

22927

Investigational Site Number 2760001, Großhansdorf

27517

Investigational Site Number 8400019, Chapel Hill

27607

Investigational Site Number 8400004, Raleigh

32216

Investigational Site Number 8400013, Jacksonville

33070

Investigational Site Number 7920002, Mersin

34098

Investigational Site Number 7920001, Istanbul

35040

Investigational Site Number 7920006, Izmir

35110

Investigational Site Number 7920007, Izmir

46000

Investigational Site Number 8040003, Ternopil

53228

Investigational Site Number 8400008, Greenfield

55407

Investigational Site Number 8400011, Minneapolis

56068

Investigational Site Number 2760007, Koblenz

58001

Investigational Site Number 8040008, Chernivtsi

61039

Investigational Site Number 8040002, Kharkiv

61166

Investigational Site Number 8040011, Kharkiv

65025

Investigational Site Number 8040006, Odesa

71450

Investigational Site Number 7920008, Kırıkkale

75093

Investigational Site Number 8400007, Plano

76000

Investigational Site Number 8040012, Ivano-Frankivsk

76018

Investigational Site Number 8040004, Ivano-Frankivsk

81377

Investigational Site Number 2760004, München

90025

Investigational Site Number 8400002, Los Angeles

90274

Investigational Site Number 8400006, Rolling Hills Estates

92506

Investigational Site Number 8400003, Riverside

92683

Investigational Site Number 8400015, Westminster

97504

Investigational Site Number 8400001, Medford

109240

Investigational Site Number 6430003, Moscow

109544

Investigational Site Number 6430001, Moscow

115280

Investigational Site Number 6430005, Moscow

117546

Investigational Site Number 6430002, Moscow

193231

Investigational Site Number 6430007, Saint Petersburg

194291

Investigational Site Number 6430010, Saint Petersburg

194354

Investigational Site Number 6430006, Saint Petersburg

355030

Investigational Site Number 6430009, Stavropol

432017

Investigational Site Number 6430004, Ulyanovsk

2260877

Investigational Site Number 1520002, Quillota

7500692

Investigational Site Number 1520001, Santiago

8330336

Investigational Site Number 1520007, Santiago

8910131

Investigational Site Number 1520004, Santiago

02747

Investigational Site Number 8400016, North Dartmouth

Investigational Site Number 8400020, South Dartmouth

11418-2619

Investigational Site Number 8400005, Jamaica

C1121ABE

Investigational Site Number 0320001, Buenos Aires

C1414AIF

Investigational Site Number 0320005, Caba

C1425BEN

Investigational Site Number 0320002, Caba

C1425FVH

Investigational Site Number 0320004, Caba

B1878FNR

Investigational Site Number 0320006, Quilmes

L7N 3V2

Investigational Site Number 1240002, Burlington

L8N 4A6

Investigational Site Number 1240009, Hamilton

H2X 3E4

Investigational Site Number 1240003, Montreal

H4A 3J1

Investigational Site Number 1240001, Montreal

G1V 4G5

Investigational Site Number 1240005, Québec

J6E 2B4

Investigational Site Number 1240006, Saint-Charles-Borromée

G8T 7A1

Investigational Site Number 1240008, Trois-Rivières

V6Z 1Y6

Investigational Site Number 1240007, Vancouver

G6P 6P6

Investigational Site Number 1240004, Victoriaville

Unknown

Investigational Site Number 1520005, Talca

Investigational Site Number 1520003, Talcahuano

15-010

Investigational Site Number 6160001, Bialystok

15-044

Investigational Site Number 6160008, Bialystok

85-079

Investigational Site Number 6160005, Bydgoszcz

86-300

Investigational Site Number 6160009, Grudziądz

31-559

Investigational Site Number 6160007, Krakow

60-693

Investigational Site Number 6160002, Poznan

60-823

Investigational Site Number 6160006, Poznan

35-205

Investigational Site Number 6160010, Rzeszów

88-400

Investigational Site Number 6160003, Żnin

06100

Investigational Site Number 7920004, Ankara

02091

Investigational Site Number 8040007, Kyiv

02125

Investigational Site Number 8040001, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT03546907 - 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) | Biotech Hunter | Biotech Hunter