Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
About this trial
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Weight ≥40kg
Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
NCS ≥2 at screening and baseline.
Disqualifiers
Any comorbidities that may affect the efficacy evaluation of nasal polyps.
Any comorbidities except for asthma that may affect blood EOS levels.
Concomitant with immunodeficiency.
Concomitant with contraindications or not suitable for nasal endoscopy.
Trial design
Design model
Parallel
Treatments tested in this trial
SHR-1905 Injection
DrugSHR-1905 Injection
SHR-1905 Placebo Injection
DrugSHR-1905 Placebo Injection
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: SHR-1905 InjectionExperimental treatment 1 intervention
Group B: SHR-1905 Placebo InjectionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nasal polyp scores (NPS)
Change from baseline in NPS at Week 24.
Time frame
Baseline to Week 242
Nasal Congestion Scores (NCS)
from baseline in NPS at Week 24.
Time frame
Baseline to Week 24Secondary outcomes
1
Lund Mackay score (LMK) from baseline on sinus CT scan
Time frame
Baseline to Week 242
Loss of smell
Time frame
Baseline to Week 243
Proportion of subjects with NPS≤1 point per nostril
Time frame
Baseline to Week 244
Sino-nasal outcome test-22 (SNOT-22) scores
Time frame
Baseline to Week 24Sponsors and contacts
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Source ClinicalTrials.gov