A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps

Launched by GENRIX (SHANGHAI) BIOPHARMACEUTICAL CO., LTD. · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GR1802 for adults with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition that causes ongoing nasal congestion and can lead to surgery if not managed effectively. The main goals are to find out if GR1802 can help reduce the need for surgery and steroid medications while also monitoring any side effects participants might experience. To do this, researchers will compare GR1802 to a placebo, which looks like the medication but contains no active ingredients.

Participants in the trial will need to be adults aged 18 to 75 who have been diagnosed with CRSwNP and have had treatment with steroids or surgery in the past. If chosen, they will take GR1802 or a placebo every two weeks for 13 months and will attend regular clinic visits for check-ups. Participants will also keep a diary to track their symptoms and any nasal spray use. It’s important to note that there are specific criteria for joining the trial, such as not having certain other medical conditions or recent treatments that may affect eligibility. If you're interested in participating, it’s a great opportunity to help researchers learn more about this potential new treatment!

Gender

ALL

Eligibility criteria

• 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.
• • 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.