Suspended

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps

What is being tested

SHR-1905 Injection

+ SHR-1905 Placebo Injection

Drug

Who is being recruted

From 18 to 75 Years

+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: September 2023

See protocol details

Summary

Principal SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 4, 2023

Actual date on which the first participant was enrolled.

The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.

Official TitleA Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps

NCT05891483

Principal SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

114 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate

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.

Show More Criteria

24 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Eye & Ent Hospital of Fudan University

Shanghai, ChinaOpen Eye & Ent Hospital of Fudan University in Google Maps

SuspendedOne Study Center