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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lunsekimig, Mometasone furoate nasal spray (MFNS).
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis With Nasal Polyps. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Bulgaria, Poland +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
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.
Interventions
- Drug Lunsekimig
* Pharmaceutical form: solution for injection * Route of administration: subcutaneous - Drug Mometasone furoate nasal spray (MFNS)
* Pharmaceutical form: Solution for administration via spray pump * Route of administration: intranasal spray
Primary outcome measures
- 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 outcome measures (5)
- Change in Sino-nasal Outcome Test 22 (SNOT-22) total score [Time frame: From the parent study baseline to Weeks 52, 96 and 144]
- Change in Rhinosinusitis visual analog scale (VAS) [Time frame: From the parent study baseline to Weeks 52, 96 and 144]
- Change in The University of Pennsylvania Smell Identification Test (UPSIT) score [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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Modena Allergy + Asthma- Site Number : 8400005 — La Jolla
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 — Roseville
- Treasure Valley Medical Research- Site Number : 8400002 — Boise
- Essential Medical Research- Site Number : 8400020 — Tulsa
- McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400 — Bellaire
- Pharmaceutical Research & Consulting- Site Number : 8400004 — Dallas
- ENT Associates of Texas - McKinne- Site Number : 8400014 — McKinney
- Alamo ENT Associates- Site Number : 8400001 — San Antonio
- … and 1 more center
Poland · 6 centers
- Investigational Site Number : 6160004 — Poznan
- Investigational Site Number : 6160002 — Krakow
- Investigational Site Number : 6160007 — Wroclaw
- Investigational Site Number : 6160001 — Warsaw
- Investigational Site Number : 6160005 — Warsaw
- Investigational Site Number : 6160003 — Katowice
Argentina · 3 centers
- Investigational Site Number : 0320002 — Rosario
- Investigational Site Number : 0320001 — Buenos Aires
- Investigational Site Number : 0320003 — Mendoza
United Kingdom · 3 centers
- Investigational Site Number : 8260004 — Gloucester
- Investigational Site Number : 8260003 — Manchester
- Investigational Site Number : 8260001 — Newcastle upon Tyne
Belgium · 2 centers
- Investigational Site Number : 0560002 — Ghent
- Investigational Site Number : 0560001 — Leuven
Bulgaria · 1 center
- Investigational Site Number : 1000001 — Sofia
Identifiers
NCT: NCT06914908 · LTS18300 · 2024-515912-27 · U1111-1308-9807