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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, United States
RECRUITINGTreasure Valley Medical Research- Site Number : 8400002
Boise, Idaho, United States
RECRUITINGEssential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, United States
RECRUITINGMcGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire, Texas, United States
RECRUITINGPharmaceutical Research & Consulting- Site Number : 8400004
Dallas, Texas, United States
RECRUITINGENT Associates of Texas - McKinne- Site Number : 8400014
McKinney, Texas, United States
RECRUITINGAlamo ENT Associates- Site Number : 8400001
San Antonio, Texas, United States
RECRUITINGInvestigational Site Number : 0320002
Rosario, Santa Fe Province, Argentina
RECRUITINGInvestigational Site Number : 0320001
Buenos Aires, Argentina
RECRUITINGInvestigational Site Number : 0320003
Mendoza, Argentina
RECRUITING...and 7 more locations
Incidence of participants with treatment-emergent adverse events (TEAEs) including
Time frame: From baseline to end of study (approximately 56 weeks)
Change in 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 Week 52
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 Week 52
Change in 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 Week 52
Serum lunsekimig concentrations
Time frame: From baseline to end of study (approximately 56 weeks)
Anti-drug antibodies (ADA) against lunsekimig
Time frame: From baseline to end of study (approximately 56 weeks)
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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