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
Qualifiers
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
Treatments tested in this trial
- SHR-1905 Injection
- SHR-1905 Placebo Injection
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov