This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 injection compared with placebo in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving background treatment with mometasone furoate nasal spray (MFNS).
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AK139 in participants with chronic rhinosinusitis with nasal polyps (CRSwNP). Eligible participants will be randomized to receive AK139 or placebo in addition to background treatment with mometasone furoate nasal spray (MFNS). The study will assess the effect of AK139 on nasal polyp burden, disease symptoms, health-related quality of life, safety, PK, PD, and immunogenicity throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Eye & ENT Hospital of Fudan University
Shanghai, China
Nasal Polyp Score (NPS)
Change from baseline in Nasal Polyp Score (NPS). NPS is a bilateral endoscopic assessment scale for nasal polyposis, where each nasal cavity is scored from 0 to 4. The total score is the sum of the left and right sides, ranging from 0 to 8, with higher scores indicating more severe nasal polyp disease.
Time frame: Baseline and Week 16
Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS). NCS is a patient-reported outcome measure using a 4-point Verbal Rating Scale (VRS) ranging from 0 to 3. Higher scores indicate more severe nasal congestion.
Time frame: Baseline and Week 16
Nasal Polyp Score (NPS)
Change from baseline in Nasal Polyp Score (NPS) at each assessment visit.
Time frame: From baseline to Week 20 (excluding Week 16)
Nasal Congestion Score (NCS)
Change from baseline in Nasal Congestion Score (NCS) at each assessment visit.
Time frame: From baseline through Week 20 (excluding Week 16)
Total Symptom Score (TSS)
Change from baseline in Total Symptom Score (TSS) at each assessment visit. TSS ranged from 0 to 9, with higher scores indicating greater nasal symptom severity.
Time frame: From baseline to Week 20
Sino-Nasal Outcome Test-22 (SNOT-22)
Change from baseline in Total Score of Sino-Nasal Outcome Test-22 (SNOT-22) at each assessment visit. SNOT-22 is a validated patient-reported questionnaire used to assess symptom severity and health-related quality of life (HRQoL) in patients with chronic rhinosinusitis (CRS). Scores range from 0 to 110, with higher scores indicating greater symptom burden and poorer HRQoL.
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Time frame: From baseline to Week 20
Lund-Mackay Score
Change from baseline in Lund-Mackay Score on CT scan. The Lund-Mackay score ranges from 0 to 24, with higher scores indicating more severe sinonasal disease.
Time frame: Baseline and Week 16
Safety parameters
Assessment of safety, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant findings from physical examinations, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs).
Time frame: Up to Week 20
Pharmacokinetics (PK)
Serum concentrations of AK139 following administration.
Time frame: Up to Week 20
Pharmacodynamics (PD)
Change from baseline in serum biomarker levels.
Time frame: From baseline to Week 20
Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb)
Incidence of Anti-drug antibodies(ADA) and Neutralizing antibody (Nab) after treatment.
Time frame: Up to Week 20