Actively Recruiting

Phase 3
Age: 40Years - 80Years
All Genders
NCT07190222

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

194

Research Sites

226 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 and 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
  • On triple COPD therapy (ICS+LABA+LAMA) for at least 12 consecutive weeks
  • Blood eosinophil count (EOS) 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...

  • Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
  • Significant pulmonary disease other than COPD
  • Long-term oxygen therapy greater than 4.0 L/min or needing more than 2.0 L/min to keep oxygen saturation above 88% at rest
  • Unstable health 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 immunosuppressants 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: 194 locations

1

Tucson Clinical Research Institute- Site Number : 8400006

Tucson, Arizona, United States, 85712

Actively Recruiting

2

Inglewood Clinical- Site Number : 8400074

Inglewood, California, United States, 90301

Actively Recruiting

3

Ark Clinical Research- Site Number : 8400113

Long Beach, California, United States, 90815

Actively Recruiting

4

Alliance Clinical - West Hills- Site Number : 8400067

Los Angeles, California, United States, 91307

Actively Recruiting

5

California Medical Research Associates - Northridge- Site Number : 8400089

Northridge, California, United States, 91324

Actively Recruiting

6

Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005

Boulder, Colorado, United States, 80301

Actively Recruiting

7

Critical Care Pulmonary & Sleep Associates- Site Number : 8400081

Lakewood, Colorado, United States, 80228

Actively Recruiting

8

Finlay Medical Research - Greenacres- Site Number : 8400107

Greenacres City, Florida, United States, 33467

Actively Recruiting

9

Direct Helpers Research Center- Site Number : 8400057

Hialeah, Florida, United States, 33012

Actively Recruiting

10

Pulmonary Specialists of the Palm Beaches- Site Number : 8400017

Loxahatchee Groves, Florida, United States, 33470

Actively Recruiting

11

DL Research Solutions- Site Number : 8400140

Miami, Florida, United States, 33155

Actively Recruiting

12

Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027

Miami, Florida, United States, 33165

Actively Recruiting

13

Professional Research Center- Site Number : 8400046

Miami, Florida, United States, 33172

Actively Recruiting

14

Research Institute of South Florida- Site Number : 8400028

Miami, Florida, United States, 33173

Actively Recruiting

15

Innovations Biotech- Site Number : 8400019

Miami, Florida, United States, 33186

Actively Recruiting

16

Florida Institute for Clinical Research- Site Number : 8400001

Orlando, Florida, United States, 32825

Actively Recruiting

17

Avanza Medical Research Center- Site Number : 8400015

Pensacola, Florida, United States, 32503

Actively Recruiting

18

Hull and Hull Medical Specialists- Site Number : 8400002

Plantation, Florida, United States, 33324

Actively Recruiting

19

Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400041

Sarasota, Florida, United States, 34239

Actively Recruiting

20

Appalachian Clinical Research- Site Number : 8400060

Adairsville, Georgia, United States, 30103

Actively Recruiting

21

Christie Clinic in Champaign on University- Site Number : 8400023

Champaign, Illinois, United States, 61820

Actively Recruiting

22

Sneeze Wheeze & Itch Associates- Site Number : 8400020

Normal, Illinois, United States, 61761

Actively Recruiting

23

Peoria Pulmonary Associates Ltd- Site Number : 8400095

Peoria, Illinois, United States, 61603

Actively Recruiting

24

Asha Clinical Research - Munster- Site Number : 8400115

Hammond, Indiana, United States, 46324

Actively Recruiting

25

Care Access - Shreveport - Youree Drive- Site Number : 8400007

Shreveport, Louisiana, United States, 71105

Actively Recruiting

26

Lucida Clinical Trials- Site Number : 8400101

New Bedford, Massachusetts, United States, 02740

Actively Recruiting

27

Vitalis Clinical Research Center- Site Number : 8400040

Allen Park, Michigan, United States, 48101

Actively Recruiting

28

Bolt Clinical Research- Site Number : 8400086

Brighton, Michigan, United States, 48116

Actively Recruiting

29

Hannibal Regional Healthcare System- Site Number : 8400035

Hannibal, Missouri, United States, 63401

Actively Recruiting

30

Excel Clinical Research - Las Vegas- Site Number : 8400070

Las Vegas, Nevada, United States, 89109

Actively Recruiting

31

AB Clinical Trials- Site Number : 8400075

Las Vegas, Nevada, United States, 89119

Completed

32

Bioluminux Clinical Research - Hamilton, New Jersey- Site Number : 8400037

Hamilton, New Jersey, United States, 08690

Actively Recruiting

33

Mid Hudson Medical Research - New Windsor- Site Number : 8400004

New Windsor, New York, United States, 12553

Actively Recruiting

34

East Carolina University- Site Number : 8400102

Greenville, North Carolina, United States, 27858

Actively Recruiting

35

Piedmont Healthcare - Family Medicine- Site Number : 8400022

Statesville, North Carolina, United States, 28625

Actively Recruiting

36

All-Trials Clinical Research- Site Number : 8400008

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

37

Asthma & Allergy Center - Toledo- Site Number : 8400110

Toledo, Ohio, United States, 43617

Actively Recruiting

38

Layrek Clinical Research- Site Number : 8400066

Tulsa, Oklahoma, United States, 74133

Actively Recruiting

39

The Oregon Clinic, PC- Site Number : 8400065

Portland, Oregon, United States, 97232

Actively Recruiting

40

MedTrial- Site Number : 8400010

Columbia, South Carolina, United States, 29204

Actively Recruiting

41

Chattanooga Research and Medicine- Site Number : 8400026

Chattanooga, Tennessee, United States, 37404

Actively Recruiting

42

IntraCare- Site Number : 8400034

Dallas, Texas, United States, 75254

Actively Recruiting

43

Premier Pulmonary Critical Care and Sleep- Site Number : 8400111

Denison, Texas, United States, 75020

Actively Recruiting

44

El Paso Pulmonary Association- Site Number : 8400033

El Paso, Texas, United States, 79902

Actively Recruiting

45

Axsendo Clinical Research - Houston- Site Number : 8400054

Houston, Texas, United States, 77058

Actively Recruiting

46

SE Houston- Site Number : 8400120

Houston, Texas, United States, 77061

Actively Recruiting

47

Synergy Group US - Missouri City- Site Number : 8400119

Missouri City, Texas, United States, 77459

Actively Recruiting

48

Synergy Group US - Missouri City- Site Number : 8400133

Missouri City, Texas, United States, 77459

Actively Recruiting

49

Elligo Health Care, Hillcroft Medical Clinic Association- Site Number : 8400053

Sugar Land, Texas, United States, 77478

Actively Recruiting

50

Medrasa Clinical Research - Wylie- Site Number : 8400124

Wylie, Texas, United States, 75098

Actively Recruiting

51

Dominion Medical Associates - Richmond - East Leigh Street- Site Number : 8400154

Richmond, Virginia, United States, 23219

Active, Not Recruiting

52

Rheumatology & Pulmonary Clinic- Site Number : 8400012

Beckley, West Virginia, United States, 25801

Actively Recruiting

53

Investigational Site Number : 0320011

Berazategui, Buenos Aires, Argentina, 1886

Actively Recruiting

54

Investigational Site Number : 0320004

Buenos Aires, Argentina, 1006

Actively Recruiting

55

Investigational Site Number : 0320002

Buenos Aires, Argentina, 1023

Actively Recruiting

56

Investigational Site Number : 0320005

Buenos Aires, Argentina, 1121

Actively Recruiting

57

Investigational Site Number : 0320006

Buenos Aires, Argentina, 1280

Actively Recruiting

58

Investigational Site Number : 0320001

Buenos Aires, Argentina, 1414

Actively Recruiting

59

Investigational Site Number : 0320012

Buenos Aires, Argentina, 1638

Actively Recruiting

60

Investigational Site Number : 0320003

Buenos Aires, Argentina, 1650

Actively Recruiting

61

Investigational Site Number : 0320009

Córdoba, Argentina, 5003

Actively Recruiting

62

Investigational Site Number : 0320007

Mendoza, Argentina, 5500

Actively Recruiting

63

Investigational Site Number : 0320008

Mendoza, Argentina, 5500

Actively Recruiting

64

Investigational Site Number : 0320010

Santa Fe, Argentina, 3000

Actively Recruiting

65

Investigational Site Number : 0360006

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

66

Investigational Site Number : 0360004

Townsville, Queensland, Australia, 4814

Actively Recruiting

67

Investigational Site Number : 0360002

Traralgon, Victoria, Australia, 3844

Actively Recruiting

68

Investigational Site Number : 0360001

Osborne Park, Western Australia, Australia, 6017

Actively Recruiting

69

Investigational Site Number : 5540004

Dunedin, Australia, 9016

Actively Recruiting

70

Universidade Federal de Goias- Site Number : 0760002

Goiânia, Goiás, Brazil, 74605-020

Actively Recruiting

71

Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760004

Belo Horizonte, Minas Gerais, Brazil, 30150-221

Actively Recruiting

72

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil, 91010-006

Actively Recruiting

73

Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760001

São Bernardo do Campo, São Paulo, Brazil, 09715-090

Actively Recruiting

74

IBCC - Núcleo de Pesquisa e Ensino- Site Number : 0760005

São Paulo, Brazil, 04014-002

Actively Recruiting

75

Investigational Site Number : 1240051

Kelowna, British Columbia, Canada, V1Y 4N7

Actively Recruiting

76

Investigational Site Number : 1240052

West Vancouver, British Columbia, Canada, V7T 2Z3

Actively Recruiting

77

Investigational Site Number : 1240041

Windsor, Ontario, Canada, N8X 1T3

Actively Recruiting

78

Investigational Site Number : 1240049

Longueuil, Quebec, Canada, J4K 1C8

Actively Recruiting

79

Investigational Site Number : 1240055

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

80

Investigational Site Number : 1240047

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

81

Investigational Site Number : 1240053

Québec, Quebec, Canada, G2J 0C4

Actively Recruiting

82

Investigational Site Number : 1240050

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

Actively Recruiting

83

Investigational Site Number : 1240054

Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

Actively Recruiting

84

Investigational Site Number : 1240048

Trois-Rivières, Quebec, Canada, G8T 7A1

Actively Recruiting

85

Investigational Site Number : 1240042

Victoriaville, Quebec, Canada, G6P 3Z8

Actively Recruiting

86

Investigational Site Number : 1520006

Temuco, La Araucanía, Chile, 4810345

Actively Recruiting

87

Investigational Site Number : 1520004

Recoleta, Reg Metropolitana de Santiago, Chile, 8420000

Actively Recruiting

88

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile, 7500587

Actively Recruiting

89

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile, 7750495

Actively Recruiting

90

Investigational Site Number : 1520009

Santiago, Reg Metropolitana de Santiago, Chile, 8380453

Actively Recruiting

91

Investigational Site Number : 1520003

Viña del Mar, Valparaiso, Chile, 2540364

Actively Recruiting

92

Investigational Site Number : 1520007

Chillan, Chile, 3800761

Actively Recruiting

93

Investigational Site Number : 1560003

Baotou, China, 014010

Actively Recruiting

94

Investigational Site Number : 1560022

Beijing, China, 100020

Actively Recruiting

95

Investigational Site Number : 1560001

Beijing, China, 100029

Actively Recruiting

96

Investigational Site Number : 1560023

Beijing, China, 100038

Actively Recruiting

97

Investigational Site Number : 1560005

Beijing, China, 100191

Actively Recruiting

98

Investigational Site Number : 1560090

Changde, China, 415000

Actively Recruiting

99

Investigational Site Number : 1560057

Changsha, China, 410008

Actively Recruiting

100

Investigational Site Number : 1560052

Chengdu, China, 610000

Actively Recruiting

101

Investigational Site Number : 1560032

Chengdu, China, 610081

Actively Recruiting

102

Investigational Site Number : 1560037

Chongqing, China, 400010

Actively Recruiting

103

Investigational Site Number : 1560074

Chongqing, China

Actively Recruiting

104

Investigational Site Number : 1560051

Foshan, China, 528399

Actively Recruiting

105

Investigational Site Number : 1560042

Ganzhou, China, 341000

Actively Recruiting

106

Investigational Site Number : 1560015

Guangzhou, China, 510180

Actively Recruiting

107

Investigational Site Number : 1560034

Guangzhou, China, 511400

Actively Recruiting

108

Investigational Site Number : 1560038

Guiyang, China, 550004

Actively Recruiting

109

Investigational Site Number : 1560016

Haikou, China, 570216

Actively Recruiting

110

Investigational Site Number : 1560009

Hangzhou, China, 310009

Actively Recruiting

111

Investigational Site Number : 1560066

Hangzhou, China, 310009

Actively Recruiting

112

Investigational Site Number : 1560054

Hebei, China, 050051

Actively Recruiting

113

Investigational Site Number : 1560059

Hefei, China, 230011

Actively Recruiting

114

Investigational Site Number : 1560007

Hohhot, China, 010070

Actively Recruiting

115

Investigational Site Number : 1560050

Honghehanizu, China, 654400

Actively Recruiting

116

Investigational Site Number : 1560046

Huaian City, China

Actively Recruiting

117

Investigational Site Number : 1560004

Huizhou, China, 516002

Actively Recruiting

118

Investigational Site Number : 1560021

Huzhou, China, 313000

Actively Recruiting

119

Investigational Site Number : 1560065

Jiangyin, China, 214400

Actively Recruiting

120

Investigational Site Number : 1560081

Jiaxing, China, 314001

Actively Recruiting

121

Investigational Site Number : 1560055

Jinan, China, 250001

Actively Recruiting

122

Investigational Site Number : 1560028

Jinan, China, 250013

Actively Recruiting

123

Investigational Site Number : 1560013

Jinan, China, 250014

Actively Recruiting

124

Investigational Site Number : 1560079

Jingzhou, China, 434020

Actively Recruiting

125

Investigational Site Number : 1560040

Jining, China, 272029

Actively Recruiting

126

Investigational Site Number : 1560061

Kunming, China, 650011

Actively Recruiting

127

Investigational Site Number : 1560077

Luoyang, China, 471002

Actively Recruiting

128

Investigational Site Number : 1560063

Meihekou, China, 135022

Actively Recruiting

129

Investigational Site Number : 1560014

Nanchang, China, 330006

Actively Recruiting

130

Investigational Site Number : 1560087

Nanchang, China, 330008

Actively Recruiting

131

Investigational Site Number : 1560047

Nanjing, China, 210006

Actively Recruiting

132

Investigational Site Number : 1560082

Nanjing, China, 211100

Actively Recruiting

133

Investigational Site Number : 1560018

Nanyang, China, 473014

Actively Recruiting

134

Investigational Site Number : 1560073

Panjin, China, 422000

Actively Recruiting

135

Investigational Site Number : 1560043

Qingyuan, China, 511518

Actively Recruiting

136

Investigational Site Number : 1560025

Qinhuangdao, China, 066000

Actively Recruiting

137

Investigational Site Number : 1560031

Qiqihar, China, 161000

Actively Recruiting

138

Investigational Site Number : 1560045

Quzhou, China, 324000

Actively Recruiting

139

Investigational Site Number : 1560008

Shanghai, China, 200025

Actively Recruiting

140

Investigational Site Number : 1560017

Shanghai, China, 201200

Actively Recruiting

141

Investigational Site Number : 1560072

Shaoyang, China, 422000

Actively Recruiting

142

Investigational Site Number : 1560035

Shenyang, China, 110000

Actively Recruiting

143

Investigational Site Number : 1560053

Shijiazhuang, China, 050031

Actively Recruiting

144

Investigational Site Number : 1560002

Suzhou, China, 215006

Actively Recruiting

145

Investigational Site Number : 1560024

Taiyuan, China, 030032

Actively Recruiting

146

Investigational Site Number : 1560075

Ürümqi, China, 830001

Actively Recruiting

147

Investigational Site Number : 1560033

Weifang, China, 261041

Actively Recruiting

148

Investigational Site Number : 1560036

Wenzhou, China, 325027

Actively Recruiting

149

Investigational Site Number : 1560019

Wuhan, China, 430014

Actively Recruiting

150

Investigational Site Number : 1560071

Wuhan, China, 430022

Actively Recruiting

151

Investigational Site Number : 1560070

Xi'an, China, 710004

Actively Recruiting

152

Investigational Site Number : 1560020

Xi'an, China, 710126

Actively Recruiting

153

Investigational Site Number : 1560083

Xiangyang, China, 441021

Actively Recruiting

154

Investigational Site Number : 1560006

Xinxiang, China, 453000

Actively Recruiting

155

Investigational Site Number : 1560058

Xuzhou, China, 221018

Actively Recruiting

156

Investigational Site Number : 1560089

Yinchuan, China, 750004

Actively Recruiting

157

Investigational Site Number : 1560076

Yiyang, China, 413000

Actively Recruiting

158

Investigational Site Number : 1560044

Zhangzhou, China, 363000

Actively Recruiting

159

Investigational Site Number : 1560084

Zigong, China, 643000

Actively Recruiting

160

Investigational Site Number : 1560039

Zunyi, China, 563002

Actively Recruiting

161

Investigational Site Number : 4580005

Miri, Malaysia, 98000

Actively Recruiting

162

Investigational Site Number : 4580007

Sibu, Malaysia, 96000

Actively Recruiting

163

Investigational Site Number : 5540003

Christchurch, Canterbury, New Zealand, 8011

Actively Recruiting

164

Investigational Site Number : 5540002

Ebdentown, Wellington Region, New Zealand, 5018

Actively Recruiting

165

Investigational Site Number : 5540001

Auckland, New Zealand, 0622

Actively Recruiting

166

Investigational Site Number : 7020001

Singapore, Singapore, 529889

Actively Recruiting

167

Investigational Site Number : 7100001

Cape Town, Alberta, South Africa, 7530

Actively Recruiting

168

Investigational Site Number : 7100003

Cape Town, South Africa, 7764

Actively Recruiting

169

Investigational Site Number : 7100013

Krugersdorp, South Africa, 1739

Actively Recruiting

170

Investigational Site Number : 7100012

Pretoria, South Africa, 0084

Actively Recruiting

171

Investigational Site Number : 4100007

Anyang-si, Gyeonggi-do, South Korea, 14068

Actively Recruiting

172

Investigational Site Number : 4100005

Daegu, Gyeongsangbuk-do, South Korea, 42415

Actively Recruiting

173

Investigational Site Number : 4100003

Jeonju, Jeollabuk-do, South Korea, 54907

Actively Recruiting

174

Investigational Site Number : 4100004

Seoul, Seoul-teukbyeolsi, South Korea, 05030

Actively Recruiting

175

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea, 05355

Actively Recruiting

176

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea, 06591

Actively Recruiting

177

Investigational Site Number : 4100006

Seoul, Seoul-teukbyeolsi, South Korea, 07061

Actively Recruiting

178

Investigational Site Number : 1580007

Changhua, Taiwan, 500

Actively Recruiting

179

Investigational Site Number : 1580006

Guishan, Taiwan, 333

Actively Recruiting

180

Investigational Site Number : 1580008

Hsinchu, Taiwan, 300

Actively Recruiting

181

Investigational Site Number : 1580001

Kaohsiung City, Taiwan, 807

Actively Recruiting

182

Investigational Site Number : 1580005

Taipei, Taiwan, 100

Actively Recruiting

183

Investigational Site Number : 1580002

Taipei, Taiwan, 110

Actively Recruiting

184

Investigational Site Number : 1580003

Taipei, Taiwan, 112

Actively Recruiting

185

Investigational Site Number : 8260035

Milton Keynes, Buckinghamshire, United Kingdom, MK19 6FG

Actively Recruiting

186

Investigational Site Number : 8260007

London, England, United Kingdom, E11 1NR

Actively Recruiting

187

Investigational Site Number : 8260008

London, Hammersmith and Fulham, United Kingdom, W6 8RF

Actively Recruiting

188

Investigational Site Number : 8260006

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

189

Investigational Site Number : 8260001

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

Actively Recruiting

190

Investigational Site Number : 8260016

London, London, City of, United Kingdom, SW1P 2PF

Actively Recruiting

191

Investigational Site Number : 8260030

Salford, Manchester, United Kingdom, M6 8HD

Actively Recruiting

192

Investigational Site Number : 8260013

Chertsey, Surrey, United Kingdom, KT16 0PZ

Actively Recruiting

193

Investigational Site Number : 8260005

Reading, United Kingdom, RG1 5AN

Actively Recruiting

194

Investigational Site Number : 8260017

Rotherham, United Kingdom, S61 1AH

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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