Actively Recruiting
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
Led by Sanofi · Updated on 2026-04-09
900
Participants Needed
118
Research Sites
329 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.
CONDITIONS
Official Title
Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed the 48-week treatment period of Study DRI16762 or ACT18301, including the end of treatment visit
- Stable background therapy with moderate or high-dose inhaled corticosteroids combined with controller medications as per parent study
- Willing and able to participate in the open-label extension study and comply with study visits and procedures
- Use contraception: females must agree to contraception/barrier methods, not be pregnant or breastfeeding, and not donate or preserve eggs; males must not donate or preserve sperm
- Capable of giving signed informed consent
You will not qualify if you...
- Developed a new medical condition or change in an existing condition requiring new treatment that may affect study participation or require stopping lunsekimig
- Diagnosed with a new lung disease impairing lung function
- Current smoker or active vaping, including marijuana use
- Significant prescription drug or substance abuse, including alcohol
- History of allergy to lunsekimig or its components, or other allergies contraindicating study participation
- Receiving prohibited medications
- Experienced adverse events related to lunsekimig in the parent study that pose risk
- Participating in another clinical study
- Legally institutionalized or prisoners
- Employees of the study site or immediate family members involved in the study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 118 locations
1
Tucson Clinical Research Institute- Site Number : 8400085
Tucson, Arizona, United States, 85712
Actively Recruiting
2
Allianz Research Institute - Aurora- Site Number : 8400026
Aurora, Colorado, United States, 80014
Actively Recruiting
3
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
4
Helix Biomedics- Site Number : 8400114
Boynton Beach, Florida, United States, 33435
Actively Recruiting
5
Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay, Florida, United States, 33157
Actively Recruiting
6
Qway Research - Hialeah- Site Number : 8400015
Hialeah, Florida, United States, 33010
Actively Recruiting
7
Clintex Research Group - Miami - Southwest 27th Avenue- Site Number : 8400048
Miami, Florida, United States, 33135
Active, Not Recruiting
8
High Quality Research- Site Number : 8400039
Miami, Florida, United States, 33184
Actively Recruiting
9
Innovations Biotech- Site Number : 8400040
Miami, Florida, United States, 33186
Actively Recruiting
10
New Access Medical Center- Site Number : 8400043
Miami, Florida, United States, 33186
Actively Recruiting
11
Deluxe Health Center- Site Number : 8400045
Miami Lakes, Florida, United States, 33014
Actively Recruiting
12
Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota, Florida, United States, 34239
Actively Recruiting
13
University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Midwest Clinical Research Center - St. Louis- Site Number : 8400006
St Louis, Missouri, United States, 63141
Actively Recruiting
15
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte, North Carolina, United States, 28287
Actively Recruiting
16
Asthma & Allergy Center - Toledo- Site Number : 8400017
Toledo, Ohio, United States, 43617
Actively Recruiting
17
OK Clinical Research- Site Number : 8400021
Edmond, Oklahoma, United States, 73034
Actively Recruiting
18
Clinical Research Associates of Central PA- Site Number : 8400116
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
19
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
20
Orion Clinical Research- Site Number : 8400001
Austin, Texas, United States, 78759
Actively Recruiting
21
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
Boerne, Texas, United States, 78006
Actively Recruiting
22
Baylor University Medical Center- Site Number : 8400002
Dallas, Texas, United States, 75246
Actively Recruiting
23
Western Sky Medical Research- Site Number : 8400023
El Paso, Texas, United States, 79903
Actively Recruiting
24
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney, Texas, United States, 75069
Actively Recruiting
25
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina, 1886
Actively Recruiting
26
Investigational Site Number : 0320003
La Plata, Buenos Aires, Argentina, 1900
Actively Recruiting
27
Investigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
28
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
29
Investigational Site Number : 0320008
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
30
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1121
Actively Recruiting
31
Investigational Site Number : 0320004
Buenos Aires, Argentina, 1414
Actively Recruiting
32
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1425
Actively Recruiting
33
Investigational Site Number : 0320011
Buenos Aires, Argentina, 1425
Actively Recruiting
34
Investigational Site Number : 0320009
Mendoza, Argentina, 5500
Actively Recruiting
35
Investigational Site Number : 0320010
Santa Fe, Argentina, 3000
Actively Recruiting
36
Associacao Proar- Site Number : 0760003
Salvador, Estado de Bahia, Brazil, 40060-330
Actively Recruiting
37
Universidade Federal de Goias- Site Number : 0760007
Goiânia, Goiás, Brazil, 74605-020
Actively Recruiting
38
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
Curitiba, Paraná, Brazil, 80030-110
Actively Recruiting
39
Instituto de Medicina Integral Professor Fernando Figueira- Site Number : 0760009
Recife, Pernambuco, Brazil, 50070-550
Actively Recruiting
40
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
41
Hospital Dia do Pulmão- Site Number : 0760005
Blumenau, Santa Catarina, Brazil, 89030-101
Actively Recruiting
42
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
Rio de Janeiro, Brazil, 22241-180
Actively Recruiting
43
Incor - Instituto do Coracao- Site Number : 0760011
São Paulo, Brazil, 05403-900
Actively Recruiting
44
Investigational Site Number : 1240003
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
45
Investigational Site Number : 1240004
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
46
Investigational Site Number : 1240001
Trois-Rivières, Quebec, Canada, G8T 7A1
Active, Not Recruiting
47
Investigational Site Number : 1520001
Talca, Maule Region, Chile, 3465584
Active, Not Recruiting
48
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile, 7500587
Active, Not Recruiting
49
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile, 7500692
Active, Not Recruiting
50
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile, 7500698
Active, Not Recruiting
51
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 7750495
Active, Not Recruiting
52
Investigational Site Number : 1520008
Quillota, Valparaiso, Chile, 2260877
Active, Not Recruiting
53
Investigational Site Number : 1520011
Viña del Mar, Valparaiso, Chile, 2531172
Active, Not Recruiting
54
Investigational Site Number : 1560011
Beijing, China, 100144
Actively Recruiting
55
Investigational Site Number : 1560010
Changchun, China, 130021
Actively Recruiting
56
Investigational Site Number : 1560017
Changsha, China, 410015
Actively Recruiting
57
Investigational Site Number : 1560053
Guangzhou, China, 510000
Actively Recruiting
58
Investigational Site Number : 1560009
Guangzhou, China, 510150
Actively Recruiting
59
Investigational Site Number : 1560001
Guangzhou, China, 510163
Actively Recruiting
60
Investigational Site Number : 1560006
Hefei, China, 230032
Actively Recruiting
61
Investigational Site Number : 1560014
Hohhot, China, 010050
Actively Recruiting
62
Investigational Site Number : 1560007
Nanchang, China, 330006
Actively Recruiting
63
Investigational Site Number : 1560002
Pingxiang, China, 337055
Actively Recruiting
64
Investigational Site Number : 1560013
Shanghai, China, 200433
Actively Recruiting
65
Investigational Site Number : 1560015
Shenyang, China, 110004
Actively Recruiting
66
Investigational Site Number : 1560005
Wenzhou, China, 325027
Actively Recruiting
67
Investigational Site Number : 1560003
Wuhan, China, 430030
Actively Recruiting
68
Investigational Site Number : 1560004
Xuzhou, China, 221006
Actively Recruiting
69
Investigational Site Number : 1560016
Yangzhou, China, 225000
Actively Recruiting
70
Investigational Site Number : 1560012
Zhanjiang, China, 524004
Actively Recruiting
71
Investigational Site Number : 3560009
Hyderabad, India, 500084
Actively Recruiting
72
Investigational Site Number : 3560008
Kanpur, India, 208001
Actively Recruiting
73
Investigational Site Number : 3560007
Kozhikode, India, 673008
Actively Recruiting
74
Investigational Site Number : 3560001
Nagpur, India, 441203
Active, Not Recruiting
75
Investigational Site Number : 3560004
Pune, India, 411057
Actively Recruiting
76
Investigational Site Number : 3760006
Ashkelon, Israel, 7830604
Actively Recruiting
77
Investigational Site Number : 3760001
Haifa, Israel, 3104802
Actively Recruiting
78
Investigational Site Number : 3760008
Haifa, Israel, 3436212
Actively Recruiting
79
Investigational Site Number : 3760003
Jerusalem, Israel, 9103102
Actively Recruiting
80
Investigational Site Number : 3760002
Jerusalem, Israel, 9112001
Actively Recruiting
81
Investigational Site Number : 3760010
Petah Tikva, Israel, 4941492
Actively Recruiting
82
Investigational Site Number : 3760004
Rehovot, Israel, 7610001
Actively Recruiting
83
Investigational Site Number : 3760007
Tel Aviv, Israel, 6423906
Actively Recruiting
84
Investigational Site Number : 3920002
Sakaidechō, Kagawa-ken, Japan, 762-8550
Actively Recruiting
85
Brigham & Women's Hospital- Site Number : 8400034
Joso-Shi, Massachusetts, Japan, 3030005
Actively Recruiting
86
Investigational Site Number : 3920011
Chūō, Tokyo, Japan, 104-0031
Active, Not Recruiting
87
Investigational Site Number : 3920005
Ube, Yamaguchi, Japan, 755-8505
Actively Recruiting
88
Investigational Site Number : 3920008
Fukushima, Japan, 960-1295
Active, Not Recruiting
89
Investigational Site Number : 3920006
Kyoto, Japan, 610-0113
Actively Recruiting
90
Investigational Site Number : 3920009
Kyoto, Japan, 612-8555
Actively Recruiting
91
Investigational Site Number : 3920012
Miyazaki, Japan, 889-1692
Active, Not Recruiting
92
Investigational Site Number : 4840004
Monterrey, Nuevo León, Mexico, 66465
Actively Recruiting
93
Investigational Site Number : 4840005
San Juan del Río, Querétaro, Mexico, 76800
Actively Recruiting
94
Investigational Site Number : 4840007
Mérida, Yucatán, Mexico, 97070
Actively Recruiting
95
Investigational Site Number : 4840002
Chihuahua City, Mexico, 31000
Actively Recruiting
96
Investigational Site Number : 4840003
Durango, Mexico, 34000
Actively Recruiting
97
Investigational Site Number : 4840008
Veracruz, Mexico, 91900
Actively Recruiting
98
Investigational Site Number : 7100004
Benoni, South Africa, 1500
Actively Recruiting
99
Investigational Site Number : 7100005
Benoni, South Africa, 1500
Actively Recruiting
100
Investigational Site Number : 7100003
Cape Town, South Africa, 7530
Actively Recruiting
101
Investigational Site Number : 7100002
Cape Town, South Africa, 7700
Actively Recruiting
102
Investigational Site Number : 7100001
Durban, South Africa, 4001
Actively Recruiting
103
Investigational Site Number : 7100006
Pretoria, South Africa, 0157
Actively Recruiting
104
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea, 03080
Actively Recruiting
105
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea, 03722
Actively Recruiting
106
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea, 05030
Actively Recruiting
107
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea, 05505
Actively Recruiting
108
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, South Korea, 06351
Actively Recruiting
109
Investigational Site Number : 7920006
Bursa, Turkey (Türkiye), 16059
Actively Recruiting
110
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
111
Investigational Site Number : 7920003
Istanbul, Turkey (Türkiye), 34854
Actively Recruiting
112
Investigational Site Number : 7920005
İzmit, Turkey (Türkiye), 41001
Actively Recruiting
113
Investigational Site Number : 7920007
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
114
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye), 33070
Actively Recruiting
115
Investigational Site Number : 8260001
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
116
Investigational Site Number : 8260004
Glasgow, Glasgow City, United Kingdom, G12 0YN
Actively Recruiting
117
Investigational Site Number : 8260005
Chertsey, Surrey, United Kingdom, KT16 0PZ
Actively Recruiting
118
Investigational Site Number : 8260008
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here