A Study of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （NEZHA-1）
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
with chronic rhinosinusitis with nasal polyposis (CRSwNP).
Nasal Polyp Score (NPS) of ≥5 with a minimum score of 2 in each nasal cavity.
Nasal Congestion Score of 2 or 3 at screening period, and at least 2 at baseline.
Contraception.
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.
Vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
Trial design
Design model
Parallel
Treatments tested in this trial
CM512
Biological/VaccineAdministered subcutaneous injection
Placebo
DrugAdministered subcutaneous injection
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: CM512 Dose 1Experimental treatment 1 intervention
Group B: CM512 Dose 2Experimental treatment 1 intervention
Group C: CM512 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nasal Polyps Score (NPS)
Change from baseline in the Nasal Polyps Score (NPS) at week 24. NPS score ranges from 0-8 (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.
Time frame
at week 24Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: