Status:
RECRUITING
A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps
Lead Sponsor:
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 questio...
Detailed Description
A randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. The clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , m...
Eligibility Criteria
Inclusion
- 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
- 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.
- Presence of another diagnosis associated with nasal polyps (i.e., eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, cystic fibrosis).
- Rhinitis medicamentosa.
- Nasal septal deviation occluding at least one nostril.
- Antrochoanal polyps.
- Pregnant or lactating woman.
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06516302
Start Date
September 19 2024
End Date
October 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Beijing Tongren Hospital, Capital Medical University
Beijing, China