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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Lunsekimig

Study type: Interventional

Funder types: Industry

Identifiers

NCT06609239

LTS17231 (Other 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 moderate-to-severe asthma who have previously completed the parent study. 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.

Full description

Enter Intervention Groups

Enrollment: 467 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Participants who completed the 48-week treatment period of DRI16762 study, including EOT visit, as per protocol

2. 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) in combination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone as maintained during the parent study in which they have participated

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:

   • incapable of becoming pregnant
   • 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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467 participants in 1 patient group

Lunsekimig

Experimental group

Description:

Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval

Treatment:

Drug: Lunsekimig