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

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lunsekimig — DRUG
  * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection

Study Details

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.

Key Dates

Start date

Sep 30, 2024

Status verified

May 2026

Primary completion

Jan 20, 2031

Completion

Jan 20, 2031

Study Design

Enrollment

900 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lunsekimig
  Participants will receive subcutaneous injection of lunsekimig according to established dosing interval

Primary Outcome Measure

Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE) [ Time Frame: From study baseline to week 148 ]

Locations (27)

Find similar trials in Chandler, AZ

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