An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301

Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol

• Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:

‣ For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone

⁃ For Study ACT18301: LABA with or without LTRA

• Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures

• Contraception for male and female participants

• For female participants:

⁃ must agree to use contraception/barrier

⁃ not pregnant or breast feeding

⁃ no eggs donation or cryopreserving eggs

• For male participants:

⁃ No sperm donation or cryopreserving sperm

• Capable of giving signed informed consent

Locations
United States
Colorado
Allianz Research Institute CO- Site Number : 8400026
RECRUITING
Aurora
Western States Clinical Research Inc- Site Number : 8400014
RECRUITING
Wheat Ridge
Florida
Beautiful Minds Clinical Research Center- Site Number : 8400049
RECRUITING
Cutler Bay
Qway Research LLC- Site Number : 8400015
RECRUITING
Hialeah
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
ACTIVE_NOT_RECRUITING
Miami
High Quality Research- Site Number : 8400039
RECRUITING
Miami
Innovations Biotech- Site Number : 8400040
RECRUITING
Miami
New Access Research & Medical Center- Site Number : 8400043
RECRUITING
Miami
Deluxe Health Center- Site Number : 8400045
RECRUITING
Miami Lakes
Massachusetts
Brigham and Women's Hospital- Site Number : 8400034
RECRUITING
Boston
Michigan
University of Michigan- Site Number : 8400004
RECRUITING
Ann Arbor
North Carolina
Tryon Medical Research- Site Number : 8400029
RECRUITING
Charlotte
Ohio
Toledo Institute of Clinical Research- Site Number : 8400017
RECRUITING
Toledo
Oklahoma
OK Clinical Research, LLC- Site Number : 8400021
RECRUITING
Edmond
Pennsylvania
Allergy and Clinical Immunology Associates- Site Number : 8400007
RECRUITING
Pittsburgh
Texas
Orion Clinical Research- Site Number : 8400001
RECRUITING
Austin
South Texas Medical Research Institute, Inc., DBA TTS Research- Site Number : 8400010
RECRUITING
Boerne
Baylor Martha Foster Lung Care Center- Site Number : 8400002
RECRUITING
Dallas
Western Sky Medical Research- Site Number : 8400023
RECRUITING
El Paso
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
RECRUITING
Mckinney
Other Locations
Argentina
Investigational Site Number : 0320007
RECRUITING
Berazategui
Investigational Site Number : 0320005
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Ciudad Autonoma Bs As
Investigational Site Number : 0320001
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Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320004
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Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320009
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Mendoza
Investigational Site Number : 0320006
RECRUITING
Rosario
Investigational Site Number : 0320008
RECRUITING
San Miguel De Tucumán
Brazil
Hospital Dia do Pulmão- Site Number : 0760005
RECRUITING
Blumenau
Centro de Estudos em Terapias Inovadoras- Site Number : 0760002
RECRUITING
Curitiba
HC UFG - Hospital Das Clinicas de Goias- Site Number : 0760007
RECRUITING
Goiânia
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760006
RECRUITING
Rio De Janeiro
Proar- Site Number : 0760003
RECRUITING
Salvador
Canada
Investigational Site Number : 1240001
RECRUITING
Trois-rivières
Chile
Investigational Site Number : 1520008
ACTIVE_NOT_RECRUITING
Quillota
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520004
RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Santiago
Investigational Site Number : 1520006
ACTIVE_NOT_RECRUITING
Santiago
Investigational Site Number : 1520001
ACTIVE_NOT_RECRUITING
Talca
Investigational Site Number : 1520011
RECRUITING
Viña Del Mar
China
Investigational Site Number : 1560011
RECRUITING
Beijing
Investigational Site Number : 1560010
RECRUITING
Changchun
Investigational Site Number : 1560017
RECRUITING
Changsha
Investigational Site Number : 1560001
RECRUITING
Guangzhou
Investigational Site Number : 1560009
RECRUITING
Guangzhou
Investigational Site Number : 1560006
RECRUITING
Hefei
Investigational Site Number : 1560014
RECRUITING
Hohhot
Investigational Site Number : 1560007
RECRUITING
Nanchang
Investigational Site Number : 1560002
RECRUITING
Pingxiang
Investigational Site Number : 1560015
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Shenyang
Investigational Site Number : 1560005
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Wenzhou
Investigational Site Number : 1560003
RECRUITING
Wuhan
Investigational Site Number : 1560004
RECRUITING
Xuzhou
Investigational Site Number : 1560016
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Yangzhou
India
Investigational Site Number : 3560009
RECRUITING
Hyderabad
Investigational Site Number : 3560008
RECRUITING
Kanpur
Investigational Site Number : 3560007
RECRUITING
Kozhikode
Investigational Site Number : 3560001
RECRUITING
Nagpur
Investigational Site Number : 3560004
RECRUITING
Pune
Israel
Investigational Site Number : 3760001
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Haifa
Investigational Site Number : 3760008
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Haifa
Investigational Site Number : 3760002
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Jerusalem
Investigational Site Number : 3760003
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Jerusalem
Investigational Site Number : 3760010
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Petah Tikva
Investigational Site Number : 3760004
RECRUITING
Rehovot
Investigational Site Number : 3760007
RECRUITING
Tel Aviv
Japan
Investigational Site Number : 3920011
RECRUITING
Chuo-ku
Investigational Site Number : 3920008
RECRUITING
Fukushima
Investigational Site Number : 3920006
RECRUITING
Kyoto
Investigational Site Number : 3920009
RECRUITING
Kyoto
Investigational Site Number : 3920012
ACTIVE_NOT_RECRUITING
Miyazaki
Investigational Site Number : 3920002
RECRUITING
Sakaide-shi
Investigational Site Number : 3920005
RECRUITING
Ube
Mexico
Investigational Site Number : 4840002
RECRUITING
Chihuahua City
Investigational Site Number : 4840007
RECRUITING
Mérida
Investigational Site Number : 4840004
RECRUITING
Monterrey
Investigational Site Number : 4840005
RECRUITING
San Juan Del Río
Republic of Korea
Investigational Site Number : 4100001
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Seoul
Investigational Site Number : 4100002
RECRUITING
Seoul
Investigational Site Number : 4100004
RECRUITING
Seoul
Investigational Site Number : 4100006
RECRUITING
Seoul
South Africa
Investigational Site Number : 7100003
RECRUITING
Cape Town
Investigational Site Number : 7100001
RECRUITING
Durban
Turkey
Investigational Site Number : 7920006
RECRUITING
Bursa
Investigational Site Number : 7920002
RECRUITING
Istanbul
Investigational Site Number : 7920003
RECRUITING
Istanbul
Investigational Site Number : 7920007
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Kayseri
Investigational Site Number : 7920001
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Mersin
United Kingdom
Investigational Site Number : 8260008
RECRUITING
Bradford
Investigational Site Number : 8260001
RECRUITING
Cambridge
Investigational Site Number : 8260005
RECRUITING
Chertsey
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2031-01-20
Participants
Target number of participants: 900
Treatments
Experimental: Lunsekimig
Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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