Chronic Rhinosinusitis With Nasal Polyps
Conditions
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 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.
Interventions
DRUGLunsekimig
* Pharmaceutical form: solution for injection * Route of administration: subcutaneous
* Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of participants with treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESI), and serious adverse events (SAEs) | From baseline to Week 148 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sino-nasal Outcome Test 22 (SNOT-22) total score | From the parent study baseline to Weeks 52, 96 and 144 | 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). |
| Change in Rhinosinusitis visual analog scale (VAS) | From the parent study baseline to Weeks 52, 96 and 144 | 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. |
| Change in The University of Pennsylvania Smell Identification Test (UPSIT) score | From the parent study baseline to Weeks 52, 96 and 144 | 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. |
| Serum lunsekimig concentrations | From baseline to Week 144 | — |
| Anti-drug antibodies (ADA) against lunsekimig | From baseline to Week 144 | — |
Countries
Argentina, Belgium, Bulgaria, Poland, United Kingdom, United States
Outcome results
None listed