Actively Recruiting

Phase 3
Age: 40Years - 80Years
All Genders
NCT07190209

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Led by Sanofi · Updated on 2026-05-08

942

Participants Needed

183

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.

CONDITIONS

Official Title

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 40 to 80 years of age
  • Physician diagnosed chronic obstructive pulmonary disease (COPD) for at least 1 year
  • Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) between 20% and 70% of predicted value
  • FEV1/FVC ratio less than 0.70
  • Former or current smokers with at least 10 pack-years
  • Chronic Airways Assessment Test (CAAT) score of 10 or higher
  • At least 2 moderate or 1 severe COPD exacerbations in the prior year
  • Using triple COPD therapy (ICS+LABA+LAMA) for at least 12 consecutive weeks
  • Blood eosinophil count of 150 cells/µL or higher
  • Body Mass Index between 18.0 and 40.0 kg/m2
Not Eligible

You will not qualify if you...

  • Diagnosis of asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
  • Significant lung diseases other than COPD
  • Long-term oxygen therapy greater than 4.0 L/min or need for more than 2.0 L/min to keep oxygen saturation above 88% at rest
  • Unstable medical conditions that could affect safety or study results
  • Active or incompletely treated tuberculosis
  • Current or past cancers
  • Use of long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless stable for more than 6 months
  • Use of any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 183 locations

1

Chandler Clinical Research Trials- Site Number : 8400025

Chandler, Arizona, United States, 85224

Actively Recruiting

2

Pulmonary Associates - Phoenix - East Bell Road- Site Number : 8400114

Phoenix, Arizona, United States, 85032

Actively Recruiting

3

Epic Medical Research - Surprise- Site Number : 8400096

Surprise, Arizona, United States, 85378

Actively Recruiting

4

IMAX Clinical Trials- Site Number : 8400109

La Palma, California, United States, 90623

Actively Recruiting

5

Long Beach Research Institute- Site Number : 8400027

Long Beach, California, United States, 90805

Actively Recruiting

6

Downtown L.A. Research Center- Site Number : 8400009

Los Angeles, California, United States, 90017

Actively Recruiting

7

Newport Native MD- Site Number : 8400003

Newport Beach, California, United States, 92663

Actively Recruiting

8

Paradigm Research - Redding- Site Number : 8400108

Redding, California, United States, 96001

Actively Recruiting

9

Amicis Research Center - Valencia- Site Number : 8400119

Valencia, California, United States, 91355

Actively Recruiting

10

Helix Biomedics- Site Number : 8400065

Boynton Beach, Florida, United States, 33435

Actively Recruiting

11

Beautiful Minds Clinical Research Center- Site Number : 8400017

Cutler Bay, Florida, United States, 33157

Actively Recruiting

12

Eastern Medical Group Research- Site Number : 8400020

Fort Myers, Florida, United States, 33908

Actively Recruiting

13

Premier Medical Associates- Site Number : 8400012

Lady Lake, Florida, United States, 32159

Actively Recruiting

14

MCR Research- Site Number : 8400004

Miami, Florida, United States, 33126

Actively Recruiting

15

Nuren Medical & Research Center- Site Number : 8400030

Miami, Florida, United States, 33144

Actively Recruiting

16

Deluxe Health Center- Site Number : 8400010

Miami Lakes, Florida, United States, 33014

Actively Recruiting

17

Omega Research Consultants - Orlando - Forest City- Site Number : 8400015

Orlando, Florida, United States, 32810

Actively Recruiting

18

Broward Research Center - Pembroke Pines- Site Number : 8400053

Pembroke Pines, Florida, United States, 33024

Actively Recruiting

19

Clinical Research Trials of Florida- Site Number : 8400011

Tampa, Florida, United States, 33607

Actively Recruiting

20

Deluxe Health Center-Tampa- Site Number : 8400056

Tampa, Florida, United States, 33607

Actively Recruiting

21

Private Practice - Dr. David Kavtaradze- Site Number : 8400006

Cordele, Georgia, United States, 31015

Actively Recruiting

22

Primeway Clinical Research- Site Number : 8400121

Fayetteville, Georgia, United States, 30214

Actively Recruiting

23

University of Illinois-Chicago - College of Medicine- Site Number : 8400055

Chicago, Illinois, United States, 60612

Actively Recruiting

24

Avicenna Clinical Research- Site Number : 8400126

Chicago Ridge, Illinois, United States, 60415

Actively Recruiting

25

Indy Clinical Research- Site Number : 8400071

Indianapolis, Indiana, United States, 46268

Actively Recruiting

26

University of Kansas Medical Center- Site Number : 8400054

Kansas City, Kansas, United States, 66103

Actively Recruiting

27

Southern Clinical Research - Zachary- Site Number : 8400113

Zachary, Louisiana, United States, 70791

Actively Recruiting

28

Pulmonary and Medicine Associates- Site Number : 8400007

Warren, Michigan, United States, 48088

Actively Recruiting

29

Henderson Clinical Trials- Site Number : 8400026

Henderson, Nevada, United States, 89052

Actively Recruiting

30

Sierra Clinical Research - Las Vegas- Site Number : 8400028

Las Vegas, Nevada, United States, 89106

Actively Recruiting

31

New York Hospital Queens- Site Number : 8400058

Flushing, New York, United States, 11355

Actively Recruiting

32

Advanced Respiratory and Sleep Medicine - Hickory- Site Number : 8400013

Hickory, North Carolina, United States, 28601

Actively Recruiting

33

Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400048

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

34

Dayton Clinical Research- Site Number : 8400124

Dayton, Ohio, United States, 45409

Actively Recruiting

35

Epic Medical Research - Chickasha- Site Number : 8400097

Chickasha, Oklahoma, United States, 73018

Actively Recruiting

36

Temple University Hospital - Main Campus- Site Number : 8400059

Philadelphia, Pennsylvania, United States, 19140-5103

Actively Recruiting

37

Preferred Primary Care Physicians - Pleasant Hills- Site Number : 8400092

Pittsburgh, Pennsylvania, United States, 15236

Actively Recruiting

38

AnMed Oglesby Center- Site Number : 8400074

Anderson, South Carolina, United States, 29621

Actively Recruiting

39

MD First Research - Lancaster- Site Number : 8400102

Lancaster, South Carolina, United States, 29720

Actively Recruiting

40

REX Clinical Trials - Beaumont- Site Number : 8400014

Beaumont, Texas, United States, 77701

Actively Recruiting

41

South Texas Medical Research Institute - TTS Research- Site Number : 8400018

Boerne, Texas, United States, 78006

Actively Recruiting

42

TEN20 Clinical Research - Carrollton- Site Number : 8400141

Carrollton, Texas, United States, 75010

Actively Recruiting

43

Corsicana Medical Research- Site Number : 8400134

Corsicana, Texas, United States, 75110

Actively Recruiting

44

Texas Health Presbyterian Hospital Dallas- Site Number : 8400032

Dallas, Texas, United States, 75231

Actively Recruiting

45

Epic Medical Research - De Soto- Site Number : 8400095

DeSoto, Texas, United States, 75115

Actively Recruiting

46

Valley Institute of Research- Site Number : 8400118

Harlingen, Texas, United States, 78550

Actively Recruiting

47

Trio Clinical Trials- Site Number : 8400106

Houston, Texas, United States, 77008

Actively Recruiting

48

HDH Research- Site Number : 8400104

Houston, Texas, United States, 77022

Actively Recruiting

49

Baylor College of Medicine- Site Number : 8400076

Houston, Texas, United States, 77030

Actively Recruiting

50

Gulf Coast Clinical Research - Houston- Site Number : 8400049

Houston, Texas, United States, 77070

Actively Recruiting

51

Lumi Research - Kingwood- Site Number : 8400120

Kingwood, Texas, United States, 77339

Actively Recruiting

52

Radiance Clinical Research - Lampasas - West Avenue East- Site Number : 8400063

Lampasas, Texas, United States, 76550

Actively Recruiting

53

Discovery Clinical Trials - San Antonio- Site Number : 8400031

San Antonio, Texas, United States, 78229

Actively Recruiting

54

Bandera Family Health Care - San Antonio- Site Number : 8400021

San Antonio, Texas, United States, 78249

Actively Recruiting

55

TPMG Clinical Research Division - Williamsburg- Site Number : 8400081

Williamsburg, Virginia, United States, 23188

Actively Recruiting

56

Investigational Site Number : 0320007

La Plata, Buenos Aires, Argentina, 1900

Actively Recruiting

57

Investigational Site Number : 0320008

Lobos, Buenos Aires, Argentina, 7240

Actively Recruiting

58

Investigational Site Number : 0320004

Rosario, Santa Fe Province, Argentina, 2000

Actively Recruiting

59

Investigational Site Number : 0320012

Rosario, Santa Fe Province, Argentina, 2000

Actively Recruiting

60

Investigational Site Number : 0320006

San Miguel de Tucumán, Tucumán Province, Argentina, 4000

Actively Recruiting

61

Investigational Site Number : 0320003

San Miguel de Tucumán, Tucumán Province, Argentina, T4000

Actively Recruiting

62

Investigational Site Number : 0320011

Buenos Aires, Argentina, 1012

Actively Recruiting

63

Investigational Site Number : 0320005

Buenos Aires, Argentina, 1122

Actively Recruiting

64

Investigational Site Number : 0320010

Buenos Aires, Argentina, 1128

Actively Recruiting

65

Investigational Site Number : 0320001

Buenos Aires, Argentina, 1425

Actively Recruiting

66

Investigational Site Number : 0320002

Buenos Aires, Argentina, 1425

Actively Recruiting

67

Investigational Site Number : 0320009

Buenos Aires, Argentina, 1427

Actively Recruiting

68

Chronos Pesquisa Clínica- Site Number : 0760012

Brasília, Federal District, Brazil, 72145-450

Actively Recruiting

69

Centro de Estudos em Terapias Inovadoras- Site Number : 0760013

Curitiba, Paraná, Brazil, 80030-110

Actively Recruiting

70

Hospital Universitário Onofre Lopes- Site Number : 0760016

Natal, Rio Grande do Norte, Brazil, 59012-300

Actively Recruiting

71

LMK Servicos Medicos- Site Number : 0760018

Porto Alegre, Rio Grande do Sul, Brazil, 90480-000

Actively Recruiting

72

Instituto Ceos- Site Number : 0760005

Porto Alegre, Rio Grande do Sul, Brazil, 90480-020

Actively Recruiting

73

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001

Porto Alegre, Rio Grande do Sul, Brazil, 90610-000

Actively Recruiting

74

Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760011

São José do Rio Preto, São Paulo, Brazil, 15090-000

Actively Recruiting

75

Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760008

São José dos Campos, São Paulo, Brazil, 12230-001

Actively Recruiting

76

Hospital Copa D'Or- Site Number : 0760017

Rio de Janeiro, Brazil, 22031-011

Actively Recruiting

77

Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760010

São Paulo, Brazil, 01323-001

Actively Recruiting

78

Investigational Site Number : 1240010

Ajax, Ontario, Canada, L1S 2J5

Actively Recruiting

79

Investigational Site Number : 1240004

Guelph, Ontario, Canada, N1h 6j2

Actively Recruiting

80

Investigational Site Number : 1240012

Ottawa, Ontario, Canada, K1G 6C6

Actively Recruiting

81

Investigational Site Number : 1240009

Stoney Creek, Ontario, Canada, L8G 2V6

Actively Recruiting

82

Investigational Site Number : 1240001

Toronto, Ontario, Canada, M5T 3A9

Actively Recruiting

83

Investigational Site Number : 1520002

Valdivia, Los Ríos Region, Chile, 5110683

Actively Recruiting

84

Investigational Site Number : 1520006

Talca, Maule Region, Chile, 3465584

Active, Not Recruiting

85

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, Chile, 7500010

Actively Recruiting

86

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile, 7500692

Actively Recruiting

87

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile, 7500698

Actively Recruiting

88

Investigational Site Number : 1520007

Santiago, Reg Metropolitana de Santiago, Chile, 8320325

Actively Recruiting

89

Investigational Site Number : 1520005

Viña del Mar, Valparaiso, Chile, 2531172

Actively Recruiting

90

Investigational Site Number : 1560035

Beijing, China, 100034

Actively Recruiting

91

Investigational Site Number : 1560013

Beijing, China, 100144

Actively Recruiting

92

Investigational Site Number : 1560054

Changchun, China, 130021

Actively Recruiting

93

Investigational Site Number : 1560010

Changsha, China, 410011

Actively Recruiting

94

Investigational Site Number : 1560032

Changsha, China, 410015

Actively Recruiting

95

Investigational Site Number : 1560018

Chengdu, China, 610041

Actively Recruiting

96

Investigational Site Number : 1560004

Chengdu, China, 610072

Actively Recruiting

97

Investigational Site Number : 1560005

Chengdu, China, 611130

Actively Recruiting

98

Investigational Site Number : 1560062

Foshan, China, 528041

Actively Recruiting

99

Investigational Site Number : 1560021

Guangzhou, China, 510150

Actively Recruiting

100

Investigational Site Number : 1560001

Guangzhou, China, 510163

Actively Recruiting

101

Investigational Site Number : 1560030

Hangzhou, China, 310006

Actively Recruiting

102

Investigational Site Number : 1560024

Harbin, China, 150001

Actively Recruiting

103

Investigational Site Number : 1560012

Hefei, China, 230032

Actively Recruiting

104

Investigational Site Number : 1560046

Hefei, China, 231220

Actively Recruiting

105

Investigational Site Number : 1560044

Huizhou, China, 516001

Actively Recruiting

106

Investigational Site Number : 1560026

Jiaozuo, China, 454001

Actively Recruiting

107

Investigational Site Number : 1560039

Jinan, China, 250014

Actively Recruiting

108

Investigational Site Number : 1560049

Jinhua, China, 321000

Actively Recruiting

109

Investigational Site Number : 1560056

Jining, China, 272011

Actively Recruiting

110

Investigational Site Number : 1560023

Langfang, China, 065000

Actively Recruiting

111

Investigational Site Number : 1560033

Linhai, China, 317000

Actively Recruiting

112

Investigational Site Number : 1560002

Nanchang, China, 330006

Actively Recruiting

113

Investigational Site Number : 1560003

Nanchang, China, 330006

Actively Recruiting

114

Investigational Site Number : 1560051

Nanning, China, 530021

Actively Recruiting

115

Investigational Site Number : 1560017

Ningbo, China, 315041

Actively Recruiting

116

Investigational Site Number : 1560031

Pingxiang, China, 337055

Actively Recruiting

117

Investigational Site Number : 1560007

Shanghai, China, 200240

Actively Recruiting

118

Investigational Site Number : 1560008

Shanghai, China, 200433

Actively Recruiting

119

Investigational Site Number : 1560036

Shenyang, China, 110004

Actively Recruiting

120

Investigational Site Number : 1560037

Shenzhen, China, 518020

Actively Recruiting

121

Investigational Site Number : 1560027

Shihezi, China, 832008

Actively Recruiting

122

Investigational Site Number : 1560015

Suining, China, 629000

Actively Recruiting

123

Investigational Site Number : 1560022

Taiyuan, China, 030001

Actively Recruiting

124

Investigational Site Number : 1560034

Taizhou, China, 318000

Actively Recruiting

125

Investigational Site Number : 1560019

Tianjin, China, 300192

Actively Recruiting

126

Investigational Site Number : 1560016

Ürümqi, China, 830054

Actively Recruiting

127

Investigational Site Number : 1560029

Wenzhou, China, 325035

Actively Recruiting

128

Investigational Site Number : 1560025

Wuhan, China, 430030

Actively Recruiting

129

Investigational Site Number : 1560050

Wuxi, China, 214023

Actively Recruiting

130

Investigational Site Number : 1560052

Xi'an, China, 710004

Actively Recruiting

131

Investigational Site Number : 1560020

Xiamen, China, 361004

Actively Recruiting

132

Investigational Site Number : 1560011

Xiangtan, China, 411100

Actively Recruiting

133

Investigational Site Number : 1560055

Xianyang, China, 712000

Actively Recruiting

134

Investigational Site Number : 1560058

Xinxiang, China, 453100

Actively Recruiting

135

Investigational Site Number : 1560040

Xuzhou, China, 221006

Actively Recruiting

136

Investigational Site Number : 1560041

Yangzhou, China, 225000

Actively Recruiting

137

Investigational Site Number : 1560060

Yichang, China, 443003

Actively Recruiting

138

Investigational Site Number : 1560059

Zhanjiang, China, 524004

Actively Recruiting

139

Investigational Site Number : 1560057

Zhengzhou, China, 450052

Actively Recruiting

140

Investigational Site Number : 1560048

Zunyi, China, 563003

Actively Recruiting

141

Investigational Site Number : 2680001

Tbilisi, Georgia, 0159

Actively Recruiting

142

Investigational Site Number : 3920042

Kōnan, Aichi-ken, Japan, 483-8704

Actively Recruiting

143

Investigational Site Number : 3920032

Nagoya, Aichi-ken, Japan, 457-8511

Actively Recruiting

144

Investigational Site Number : 3920053

Kure, Hiroshima, Japan, 737-0811

Actively Recruiting

145

Investigational Site Number : 3920009

Kobe, Hyōgo, Japan, 650-0017

Actively Recruiting

146

Investigational Site Number : 3920008

Kita, Kagawa-ken, Japan, 761-0701

Actively Recruiting

147

Investigational Site Number : 3920030

Sakaidechō, Kagawa-ken, Japan, 762-8550

Actively Recruiting

148

Investigational Site Number : 3920040

Kamakura, Kanagawa, Japan, 247-8533

Actively Recruiting

149

Investigational Site Number : 3920035

Yokohama, Kanagawa, Japan, 221-0855

Actively Recruiting

150

Investigational Site Number : 3920054

Yokohama, Kanagawa, Japan, 234-0054

Actively Recruiting

151

Investigational Site Number : 3920015

Yokohama, Kanagawa, Japan, 236-0004

Actively Recruiting

152

Investigational Site Number : 3920045

Matsusaka, Mie-ken, Japan, 515-0073

Actively Recruiting

153

Investigational Site Number : 3920001

Kashihara, Nara, Japan, 634 8522

Actively Recruiting

154

Investigational Site Number : 3920012

Okayama, Okayama-ken, Japan, 701-1192

Actively Recruiting

155

Investigational Site Number : 3920043

Sakai, Osaka, Japan, 591-8555

Actively Recruiting

156

Investigational Site Number : 3920020

Ureshino, Saga-ken, Japan, 843-0393

Actively Recruiting

157

Investigational Site Number : 3920033

Hachiōji, Tokyo, Japan, 193-0998

Actively Recruiting

158

Investigational Site Number : 3920003

Ube, Yamaguchi, Japan, 755-8505

Actively Recruiting

159

Investigational Site Number : 3920021

Chiba, Japan, 260-0852

Actively Recruiting

160

Investigational Site Number : 3920026

Fukuoka, Japan, 819-0055

Actively Recruiting

161

Investigational Site Number : 3920002

Fukushima, Japan, 960-1295

Actively Recruiting

162

Investigational Site Number : 3920029

Hiroshima, Japan, 734-0004

Actively Recruiting

163

Investigational Site Number : 3920039

Kagoshima, Japan, 892-0847

Actively Recruiting

164

Investigational Site Number : 3920018

Kumamoto, Japan, 862-0909

Actively Recruiting

165

Investigational Site Number : 3920004

Osaka, Japan, 545-8586

Actively Recruiting

166

Investigational Site Number : 3920007

Saga, Japan, 849-0937

Actively Recruiting

167

Investigational Site Number : 3920028

Tokyo, Japan, 150-8935

Actively Recruiting

168

Investigational Site Number : 3920023

Tokyo, Japan, 173-8610

Actively Recruiting

169

Investigational Site Number : 7920002

Adana, Turkey (Türkiye), 01330

Actively Recruiting

170

Investigational Site Number : 7920006

Ankara, Turkey (Türkiye), 06010

Actively Recruiting

171

Investigational Site Number : 7920003

Ankara, Turkey (Türkiye), 06620

Actively Recruiting

172

Investigational Site Number : 7920004

Gaziantep, Turkey (Türkiye), 27310

Actively Recruiting

173

Investigational Site Number : 7920005

Istanbul, Turkey (Türkiye), 34020

Actively Recruiting

174

Investigational Site Number : 7920007

Izmir, Turkey (Türkiye), 35340

Actively Recruiting

175

Investigational Site Number : 7920001

Mersin, Turkey (Türkiye), 33070

Actively Recruiting

176

Investigational Site Number : 8260014

Bristol, Bristol, City of, United Kingdom, BS37 4AX

Actively Recruiting

177

Investigational Site Number : 8260015

London, Hammersmith and Fulham, United Kingdom, W6 7HY

Actively Recruiting

178

Investigational Site Number : 8260003

Leicester, Leicestershire, United Kingdom, LE1 5WW

Actively Recruiting

179

Investigational Site Number : 8260009

Harrow, London, City of, United Kingdom, HA1 3UJ

Actively Recruiting

180

Investigational Site Number : 8260031

London, London, City of, United Kingdom, Se1 7eh

Actively Recruiting

181

Investigational Site Number : 8260034

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

182

Investigational Site Number : 8260032

Worthing, West Sussex, United Kingdom, BN11 2DH

Actively Recruiting

183

Investigational Site Number : 8260002

Bradford, United Kingdom, BD9 6RJ

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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