Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.
Purpose
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.
Condition
- Asthma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol 2. 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 3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures 4. 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 5. Capable of giving signed informed consent
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: 1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures 2. Participant who was diagnosed with a new pulmonary disease which may impair lung function 3. Current smoker or active vaping of any products and/or marijuana smoking 4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator 5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study 6. Participants who are receiving prohibited concomitant medications 7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant 8. Concurrent participation in any other clinical study, including non-interventional studies 9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized 10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lunsekimig |
Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval |
|
Recruiting Locations
Tucson, Arizona 85712
Aurora, Colorado 80014
Wheat Ridge, Colorado 80033
Boynton Beach, Florida 33435
Cutler Bay, Florida 33157
Hialeah, Florida 33010
Miami, Florida 33184
Miami, Florida 33186
Miami, Florida 33186
Miami Lakes, Florida 33014
Sarasota, Florida 34239
Ann Arbor, Michigan 48109
St Louis, Missouri 63141
Charlotte, North Carolina 28287
Toledo, Ohio 43617
Edmond, Oklahoma 73034
DuBois, Pennsylvania 15801
Pittsburgh, Pennsylvania 15241
Austin, Texas 78759
Boerne, Texas 78006
Dallas, Texas 75246
El Paso, Texas 79903
McKinney, Texas 75069
More Details
- Status
- Recruiting
- Sponsor
- Sanofi
Study Contact
Trial Transparency email recommended (Toll free for US & Canada)800-633-1610
contact-us@sanofi.com
Detailed Description
Enter Intervention Groups