Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

Part of paid clinical trials in La Jolla, California.

Sponsor
Sanofi
Study ID
NCT06914908
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lunsekimig — DRUG
    * Pharmaceutical form: solution for injection * Route of administration: subcutaneous
  • Mometasone furoate nasal spray (MFNS) — DRUG
    * Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray

Study Details

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 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.

Key Dates

First listed
Apr 7, 2025
Start date
May 12, 2025
Status verified
Jun 2026
Primary completion
Jan 29, 2031
Completion
Jan 29, 2031

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lunsekimig
    Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 144 weeks

Primary Outcome Measure

Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs) [ Time Frame: From baseline to Week 148 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Modena Allergy + Asthma- Site Number : 8400005La JollaCalifornia92037-
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003RosevilleCalifornia95661-
Treasure Valley Medical Research- Site Number : 8400002BoiseIdaho83706-
Essential Medical Research- Site Number : 8400020TulsaOklahoma74137-
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017BellaireTexas77401-
Pharmaceutical Research & Consulting- Site Number : 8400004DallasTexas75231-
ENT Associates of Texas - McKinne- Site Number : 8400014McKinneyTexas75070-
Alamo ENT Associates- Site Number : 8400001San AntonioTexas78258-
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008NorfolkVirginia23510-

Find similar trials in La Jolla, CA

By research site
Modena Allergy + Asthma· La Jolla, CASacramento Ear Nose & Throat - Roseville· Roseville, CATreasure Valley Medical Research· Boise, IDEssential Medical Research· Tulsa, OKMcGovern Medical School - UT Physicians Dermatology - Bellaire Station· Bellaire, TXPharmaceutical Research & Consulting· Dallas, TX

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