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Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma

Enrolling By InvitationPhase 2

Sponsor: Sanofi

Conditions: Asthma

Interventions: Lunsekimig

Countries: United States, Argentina, Brazil, Canada, Chile, China, India, Israel

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 148 weeks with a treatment duration being up to 144 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who completed the 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 during the study intervention period and during 8 weeks following the last administration of study intervention. And:

For female participants:

* incapable of becoming pregnant, or
* 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 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 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
* Participant who was diagnosed with a new pulmonary disease which may impair lung function
* Current smoker or active vaping of any products and/or marijuana smoking
* Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
* 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
* Participants who are receiving prohibited concomitant medications
* 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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (127)

Chandler, Arizona, United States
Tucson, Arizona, United States
Aurora, Colorado, United States
Wheat Ridge, Colorado, United States
Boynton Beach, Florida, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Saint Cloud, Florida, United States
Sarasota, Florida, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Charlotte, North Carolina, United States
Toledo, Ohio, United States
Edmond, Oklahoma, United States
DuBois, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
Boerne, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
McKinney, Texas, United States
Berazategui, Buenos Aires, Argentina
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