Lunsekimig for Sinusitis with Polyps

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Intranasal steroids

Disqualifiers: Hypersensitivity, Concurrent study, Adverse events, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 52 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207). The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.

Eligibility Criteria

This trial is for adults with chronic rhinosinusitis and nasal polyps who finished a previous study on Lunsekimig. They must be using Mometasone furoate nasal spray and willing to comply with the study requirements for about 56 weeks.

Inclusion Criteria

I am currently using a nasal spray medication called mometasone.

Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol

I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

I am not allergic to lunsekimig or its ingredients.

Concurrent participation in any clinical study other than the parent study, including non-interventional studies

Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lunsekimig subcutaneous injections every 4 weeks and intranasal mometasone furoate nasal spray daily for 52 weeks

52 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lunsekimig

Trial Overview The trial is testing the long-term safety and effectiveness of Lunsekimig in participants from an earlier study. It's a single-arm extension, meaning everyone gets Lunsekimig, without comparison to another drug or placebo.

Participant Groups

Group I: Lunsekimig Experimental Treatment 2 Interventions

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University