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

NCT06914908 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: LTS183002024-515912-27U1111-1308-9807
• Study Type: interventional
• Target: 64
• Locations: 6 countries
• Sites: 24

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Incidence of participants with treatment-emergent adverse events (TEAEs) including

  From baseline to end of study (approximately 56 weeks)

Secondary Outcomes (5)

• Change in SNOT-22 total score

  From the parent study baseline to Week 52

• Change in rhinosinusitis visual analog scale (VAS)

  From the parent study baseline to Week 52

• Change in University of Pennsylvania Smell Identification Test (UPSIT) score

  From the parent study baseline to Week 52

• Serum lunsekimig concentrations

  From baseline to end of study (approximately 56 weeks)

• Anti-drug antibodies (ADA) against lunsekimig

  From baseline to end of study (approximately 56 weeks)

Study Arms (1)

Lunsekimig

EXPERIMENTAL

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

Drug: lunsekimig; Drug: Mometasone furoate nasal spray (MFNS)

Interventions

lunsekimig DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: SAR443765

Lunsekimig

Mometasone furoate nasal spray (MFNS) DRUG

Pharmaceutical form: Intranasal spray Route of administration: intranasal

Lunsekimig

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol.
• Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS).
• Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Prior hypersensitivity reaction 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.
• 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.
• NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Sponsors & Collaborators

• Sanofi: lead

Study Sites (24)

Modena Allergy + Asthma- Site Number : 8400005

La Jolla, California, 92037, United States

RECRUITING

Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003

Roseville, California, 95661, United States

RECRUITING

Treasure Valley Medical Research- Site Number : 8400002

Boise, Idaho, 83706, United States

ACTIVE NOT RECRUITING

Essential Medical Research- Site Number : 8400020

Tulsa, Oklahoma, 74137, United States

RECRUITING

McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017

Bellaire, Texas, 77401, United States

RECRUITING

Pharmaceutical Research & Consulting- Site Number : 8400004

Dallas, Texas, 75231, United States

RECRUITING

ENT Associates of Texas - McKinne- Site Number : 8400014

McKinney, Texas, 75070, United States

RECRUITING

Alamo ENT Associates- Site Number : 8400001

San Antonio, Texas, 78258, United States

RECRUITING

Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008

Norfolk, Virginia, 23510, United States

RECRUITING

Investigational Site Number : 0320002

Rosario, Santa Fe Province, 2000, Argentina

ACTIVE NOT RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1121, Argentina

ACTIVE NOT RECRUITING

Investigational Site Number : 0320003

Mendoza, 5500, Argentina

ACTIVE NOT RECRUITING

Investigational Site Number : 0560002

Ghent, 9000, Belgium

ACTIVE NOT RECRUITING

Investigational Site Number : 0560001

Leuven, 3000, Belgium

ACTIVE NOT RECRUITING

Investigational Site Number : 1000001

Sofia, 1612, Bulgaria

RECRUITING

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, 60-693, Poland

RECRUITING

Investigational Site Number : 6160002

Krakow, Lesser Poland Voivodeship, 30-033, Poland

RECRUITING

Investigational Site Number : 6160007

Wroclaw, Lower Silesian Voivodeship, 50-750, Poland

RECRUITING

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, 00-909, Poland

RECRUITING

Investigational Site Number : 6160005

Warsaw, Masovian Voivodeship, 02-507, Poland

RECRUITING

Investigational Site Number : 6160003

Katowice, Silesian Voivodeship, 40-611, Poland

RECRUITING

Investigational Site Number : 8260004

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

RECRUITING

Investigational Site Number : 8260003

Manchester, M13 9wl, United Kingdom

ACTIVE NOT RECRUITING

Investigational Site Number : 8260001

Newcastle upon Tyne, NE7 7DN, United Kingdom

ACTIVE NOT RECRUITING

Related Links

• LTS18300 Plain Language Results Summary

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 7, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): January 29, 2031
• Study Completion (Estimated): January 29, 2031
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); GB (3); PL (6); AR (3); US (9); BU (1)