A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-2）
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
Participated in the clinical study of CM512 in patients with Chronic Rhinosinusitis with Nasal Polyposis (Study No. of CM512-102101) .
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
CM512
Biological/VaccineAdministered subcutaneous injection
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: CM512Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of adverse events
Incidences of adverse events
Time frame
Up to week 60Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: