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.
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
Aurora 5412347, Colorado 5417618 80014
Wheat Ridge 5443948, Colorado 5417618 80033
Boynton Beach 4148677, Florida 4155751 33435
Cutler Bay 6332309, Florida 4155751 33157
Hialeah 4158476, Florida 4155751 33010
Miami 4164138, Florida 4155751 33184
Miami 4164138, Florida 4155751 33186
Miami 4164138, Florida 4155751 33186
Miami Lakes 4164186, Florida 4155751 33014
Sarasota 4172131, Florida 4155751 34239
Ann Arbor 4984247, Michigan 5001836 48109
St Louis 4407066, Missouri 4398678 63141
Charlotte 4460243, North Carolina 4482348 28287
Toledo 5174035, Ohio 5165418 43617
Edmond 4535740, Oklahoma 4544379 73034
Pittsburgh 5206379, Pennsylvania 6254927 15241
Austin 4671654, Texas 4736286 78759
Boerne 4675373, Texas 4736286 78006
Dallas 4684888, Texas 4736286 75246
El Paso 5520993, Texas 4736286 79903
McKinney 4710178, Texas 4736286 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