A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (NCT05865496) | Clinical Trial Compass
UnknownPhase 2
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
China90 participantsStarted 2023-06-30
Plain-language summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
. Bilateral CRSwNP.
. Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
. Nasal Congestion Score of \> 2 at screening and a weekly average severity of \> 1 at time of randomization.
. Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
Exclusion criteria
. Patients with other nasal diseases or symptoms.
. Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
. History of cancer.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS)
Timeframe: Up to 16 weeks
2
Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS)