This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks, till End-of-Treatment Visit) and a Safety Follow-up Period (8 weeks, till End-of-Study Visit). 56 patients who meet eligibility criteria will be randomized 1:1 to receive either CM310 300mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All patients will receive MFNS on a daily basis as a background treatment throughout the study. MFNS is required to use no less than 14 days during Screening/run-in Period. Central reading will be implemented to nasal endoscopic nasal polyp score (NPS) , CT scans to Lund-Mackay score and volume of the involved area of nasosinusitis on 3D-construction images, and nasal polyp biopsy tissue analysis to eosinophil counts \& percentage.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Beijing Chaoyang Hospital, CMU
Beijing, Beijing Municipality, China
Beijing Hospital
Bilateral endoscopic Nasal Polyps Score (NPS)
Change from baseline in the bilateral endoscopic NPS.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 16
Nasal Congestion/Obstruction SymptomSeverity (NCS) Score
Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.
Time frame: at Week 16
Time to the first response of NPS
Time to the first response of NPS (defined as bilateral endoscopic NPS improved ≥1).
Time frame: Baseline up to Week 24
Lund-Mackay score
Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse nasosinusitis.
Time frame: at Week 16
Volume of the involved area of nasosinusitis on 3D-construction CT scan
Change from baseline in the volume of the involved area of nasosinusitis on 3D-construction CT scan.
Time frame: at Week 16
Bilateral endoscopic NPS
Change from baseline in the bilateral endoscopic NPS.
Time frame: at Week 8
Proportion of subjects receiving rescue therapy for nasal polyps
Proportion of subjects receiving rescue therapy for nasal polyps.
Time frame: Baseline up to Week 24
University of Pennsylvania Smell Identification Test (UPSIT)
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Beijing, Beijing Municipality, China
Beijing Renmin Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
...and 9 more locations
Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.
Time frame: at Week 16
22-item Sino-nasal Outcome Test Scores(SNOT-22) score
Change from baseline in SNOT-22 score. SNOT-22 score (0-110). Higher score means a worse outcome.
Time frame: at Week 16
Total Symptom Score(TSS) score
Change from baseline in TSS score. TSS score (0-9). Higher score means worse nasal symptom.
Time frame: at Week 16
Bilateral endoscopic NPS
Change from baseline in the bilateral endoscopic NPS in subjects with concurrent asthma.
Time frame: at Week 16
Bilateral endoscopic NCS
Change from baseline in the NCS in subjects with concurrent asthma.
Time frame: at Week 16
Safety parameters
Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.
Time frame: Baseline up to Week 24
Pharmacokinetics(PK)
Trough concentration and exposure.
Time frame: Baseline up to Week 24
Pharmacodynamics(PD)
Change from baseline in serum biomarker level (TARC, total IgE and eosinophil level).
Time frame: Baseline up to Week 24
PD(eosinophil level in nasal polyps biospy tissue)
Change from baseline of eosinophil level in nasal polyps biospy tissue.
Time frame: at Week 16
Anti-drug antibodies(ADA)
Incidence of ADA.
Time frame: Baseline up to Week 24
Neutralizing antibody (Nab)
Incidence of Nab.
Time frame: Baseline up to Week 24