Phase
Condition
Asthma
Treatment
Lunsekimig
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who completed the 48-week treatment period of DRI16762 study, includingEOT visit, as per protocol
Participants with stable background therapy of moderate to high ICS therapy (≥500 µg/day to 2000 µg/day fluticasone propionate or equivalent ICS dosage daily) incombination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone asmaintained during the parent study in which they have participated
Participants who are able and willing to participate in the open-label extensionstudy, 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
Exclusion
Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
Participant who developed a new medical condition or a change in status of anestablished medical condition or requires a new treatment or medication prior toenrollment that, per Investigator's medical judgement would adversely affectparticipation of the participant in this study or would require permanent lunsekimigdiscontinuation, or participants potentially at risk of noncompliance to studyprocedures
Participant who was diagnosed with a new pulmonary disease which may impair lungfunction
Current smoker or active vaping of any products and/or marijuana smoking
Prescription drug or substance abuse, including alcohol, considered significant bythe Investigator
History of hypersensitivity or allergy to lunsekimig or to any of the excipientsused in the presentation or in preparation for administration of lunsekimig, orother allergy that, in the opinion of the Investigator, contraindicatesparticipation in the study
Participants who are receiving prohibited concomitant medications
Participants who, during their participation in the parent study, developed an AE oran SAE deemed related to lunsekimig, which in the opinion of the Investigator couldindicate that continued treatment with lunsekimig may present an unreasonable riskfor the participant
Concurrent participation in any other clinical study, including non-interventionalstudies
Individuals accommodated in an institution because of regulatory or legal order;prisoners or participants who are legally institutionalized
Participants are employees of the investigative site or other individuals directlyinvolved in the conduct of the study, or immediate family members of suchindividuals.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0320008
San Miguel de Tucumán, Tucumán 4000
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1425
ArgentinaActive - Recruiting
Investigational Site Number : 0320004
Buenos Aires, 1414
ArgentinaActive - Recruiting
Investigational Site Number : 1520001
Talca, Maule 3465584
ChileActive - Recruiting
Investigational Site Number : 1520002
Santiago, Reg Metropolitana De Santiago 7750495
ChileActive - Recruiting
Investigational Site Number : 1520004
Santiago, Reg Metropolitana De Santiago 7500698
ChileActive - Recruiting
Investigational Site Number : 1520005
Santiago, Reg Metropolitana De Santiago 7500692
ChileActive - Recruiting
Investigational Site Number : 1520006
Santiago, Reg Metropolitana De Santiago 7500587
ChileActive - Recruiting
Investigational Site Number : 1520008
Quillota, Valparaíso 2260877
ChileActive - Recruiting
Investigational Site Number : 1520011
Viña Del Mar, Valparaíso 2520598
ChileActive - Recruiting
Investigational Site Number : 1560001
Guangzhou, 510120
ChinaActive - Recruiting
Investigational Site Number : 1560014
Hohhot, 010050
ChinaActive - Recruiting
Investigational Site Number : 1560005
Wenzhou, 325027
ChinaActive - Recruiting
Investigational Site Number : 3760003
Jerusalem, 9103102
IsraelActive - Recruiting
Investigational Site Number : 3760004
Rehovot, 7610001
IsraelActive - Recruiting
Investigational Site Number : 3920002
Sakaide, Kagawa 762-8550
JapanSite Not Available
Investigational Site Number : 3920002
Sakaide-shi, Kagawa 762-8550
JapanActive - Recruiting
Investigational Site Number : 3920006
Kyoto, 610-0113
JapanActive - Recruiting
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi 03722
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi 03080
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi 05030
Korea, Republic ofActive - Recruiting
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi 05505
Korea, Republic ofActive - Recruiting
Investigational Site Number : 7920001
Akdeniz, 33070
TurkeyActive - Recruiting
Investigational Site Number : 7920002
Istanbul, 34098
TurkeyActive - Recruiting
Investigational Site Number : 7920007
Kayseri, 38039
TurkeyActive - Recruiting
Allianz Research Institute CO- Site Number : 8400026
Aurora, Colorado 80014
United StatesActive - Recruiting
Western States Clinical Research- Site Number : 8400014
Wheat Ridge, Colorado 80033
United StatesActive - Recruiting
Qway Research - Hialeah- Site Number : 8400015
Hialeah, Florida 33010
United StatesActive - Recruiting
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
Miami, Florida 33145
United StatesActive - Recruiting
High Quality Research- Site Number : 8400039
Miami, Florida 33184
United StatesActive - Recruiting
Innovations Biotech- Site Number : 8400040
Miami, Florida 33186
United StatesActive - Recruiting
New Access Medical Center- Site Number : 8400043
Miami, Florida 33186
United StatesActive - Recruiting
Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte, North Carolina 28287
United StatesActive - Recruiting
OK Clinical Research, LLC Site Number : 8400021
Edmond, Oklahoma 73034
United StatesActive - Recruiting
OK Clinical Research- Site Number : 8400021
Edmond, Oklahoma 73034
United StatesActive - Recruiting
Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh, Pennsylvania 15241
United StatesActive - Recruiting
South Texas Medical Research Institute - TTS Research- Site Number : 8400010
Boerne, Texas 78006
United StatesActive - Recruiting
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