A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps (NCT06516302) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
China228 participantsStarted 2024-09-19
Plain-language summary
The goal of this clinical trial is to learn if GR1802 works to treat severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. It will also learn about the safety of GR1802. The main questions it aims to answer are:
1. Does GR1802 reduce the need for surgery and systemic corticosteroid use？
2. What medical problems do participants have when taking GR1802?
Researchers will compare GR1802 to a placebo (a look-alike substance that contains no drug) to see if GR1802 works to treat CRSwNP.
Participants will:
Take GR1802 or a placebo once every 2 weeks for 13months. Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.
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:
* Diagnosed as CRSwNP and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening.
* An endoscopic bilateral NPS at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity).
* Nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) .
* Willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol.
Exclusion Criteria:
* Biologic therapy within 5 half-lives or within 10 weeks before baseline.
* Anti-IL-4Rα antibody before screening.
* An experimental drug within 5 half-lives or 1 months before baseline.
* Systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline.
* Initiation of allergen immunotherapy within 3 months before screening.
* Participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days.
* Participants with FEV1 50% or less of predicted normal were excluded.
* Participants who have undergone any intranasal and/or sinus surgery within 6 months before screening.
* Acute sinusitis or upper respiratory infection within a defined time period before screening.
* A nasal cavity tumor (malignant or benign).
* Evidence of fungal rhinosinusitis.
…
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 in nasal polyps score at week 24.
Timeframe: At week 24
2
Change from baseline in nasal congestion score at week 24.