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

Phase 2Enrolling By InvitationNCT06914908

Sanofi71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

LunsekimigDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Locations (24)

Modena Allergy + Asthma- Site Number : 8400005

La Jolla, California, United States

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

Roseville, California, United States

Treasure Valley Medical Research- Site Number : 8400002

Boise, Idaho, United States

Essential Medical Research- Site Number : 8400020

Tulsa, Oklahoma, United States

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

Bellaire, Texas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Change in Sino-nasal Outcome Test 22 (SNOT-22) total score

The SNOT-22 is a 22-item health-related outcomes assessment. The 22-question SNOT-22 is scored as 0 (no problem) to 5 (problem as bad as it can be) with a total range from 0 to 110 (higher scores indicate poorer outcomes).

Time frame: From the parent study baseline to Weeks 52, 96 and 144

Change in Rhinosinusitis visual analog scale (VAS)

The VAS for rhinosinusitis is used to evaluate the total severity. The participant is asked to indicate along a 10 centimeter straight horizontal line (VAS) the answer to the question: "How troublesome are your symptoms of your rhinosinusitis". The VAS ranks from 0 (Not troublesome) to 10 (Worst thinkable troublesome) and is measured in centimeters.

Time frame: From the parent study baseline to Weeks 52, 96 and 144

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

The UPSIT test is a rapid and easy-to-administer method to quantitatively assess human olfactory function. The test consists of four booklets, each containing 10 odorants with one odorant per page. Above each odorant strip is a multiple-choice question with four alternative words to describe the odor. Score depends on the amount of answers out of 40 possible correct answers.

Time frame: From the parent study baseline to Weeks 52, 96 and 144

Serum lunsekimig concentrations

Time frame: From baseline to Week 144

Anti-drug antibodies (ADA) against lunsekimig

Time frame: From baseline to Week 144