Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT06516302
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06516302
Study Brief:
Protocol Section:
NCT06516302