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

Sanofi

Status and phase

Invitation-only

Phase 2

Conditions

Asthma

Treatments

Drug: Lunsekimig

Study type

Interventional

Funder types

Industry

Identifiers

NCT06609239

LTS17231 (Other Identifier)

2025-522896-27 (Registry Identifier)

U1111-1303-3645 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.