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NCT07519577
A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis (NEZHA-2)
Conditions: Chronic Rhinosinusitis With Nasal Polyposis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Keymed Biosciences Co.Ltd
Location: Beijing Tong-Ren hospital Beijing
Summary
This is an open-label, single-arm, multicenter, extension study to evaluate the safety and efficacy of CM512 in patients With Chronic Rhinosinusitis with Nasal Polyposis
Eligibility Criteria
Inclusion Criteria:
* Participated in the clinical study of CM512 in patients with Chronic Rhinosinusitis with Nasal Polyposis (Study No. of CM512-102101) .
Exclusion Criteria:
* Not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for Interleukin (IL)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).With malignant or benign tumor of nasal cavity.
* Administration of a live attenuated vaccine within 30 days prior to baseline or planning to receive one during the study period.
Source: ClinicalTrials.gov (NCT07519577). StuddyBuddy aggregates publicly available trial information.