Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

July 20, 2026 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200031
        • Eye & ENT Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Weight ≥40kg
  2. Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP).
  3. Bilateral nasal polyps at screening and baseline, total NPS ≥5, ≥2 points for each nostril.
  4. NCS ≥2 at screening and baseline.
  5. SNOT-22≥20 at screening period and baseline.
  6. Recorded persistent NP symptoms for over 4 weeks prior to screening.
  7. Subjects received standard therapy with intranasal corticosteroids (INCS) and remained stable during the 4 weeks prior to randomization.
  8. NP surgery in the past and/or ACERS treated with SCS occurred within 2 years before randomization (or with contraindications/ intolerances).

Exclusion Criteria:

  1. Any comorbidities that may affect the efficacy evaluation of nasal polyps.
  2. Any comorbidities except for asthma that may affect blood EOS levels.
  3. Concomitant with immunodeficiency.
  4. Concomitant with contraindications or not suitable for nasal endoscopy.
  5. Uncontrolled hypertension.
  6. Uncontrolled diabetes.
  7. Infection within 2 weeks prior to screening to randomization that is clinically significant and/or should be treated with systemic antibiotics.
  8. Uncontrolled epistaxis within 4 weeks prior to randomization.
  9. Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
  10. Parasitic infection within 6 months before randomization.
  11. Sinus or intranasal surgery (except for diagnostic biopsy) within 6 months prior to randomization, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
  12. Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
  13. Abnormalities of laboratory tests at screening or baseline.
  14. Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
  15. Prolonged QTc interval (>450ms for male and >470ms for female) or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
  16. FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
  17. Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
  18. SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
  19. Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
  20. Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
  21. Allergen immunotherapy within 8 weeks before randomization.
  22. Smoking history ≥10 pack-years, smoking at screening, or smoking cessation less than 6 months at screening.
  23. Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.
  24. Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
Drug: SHR-1905 Placebo Injection
SHR-1905 Placebo Injection
Experimental: Treatment group A: SHR-1905 Injection（dose 1）
Drug: SHR-1905 Injection
SHR-1905 Injection
Experimental: Treatment group B: SHR-1905 Injection（dose 2）
Drug: SHR-1905 Injection
SHR-1905 Injection
Experimental: Treatment group C: SHR-1905 Injection（dose 3）
Drug: SHR-1905 Injection
SHR-1905 Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nasal polyp scores (NPS)
Time Frame: Baseline to Week 24
Change from baseline in NPS at Week 24.
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NPS
Time Frame: Baseline to Week 48
Changes from baseline in NPS from baseline at each evaluation time point.
Baseline to Week 48
Nasal Congestion Scores (NCS)
Time Frame: Baseline to Week 48
Changes from baseline in NCS at each evaluation time point.
Baseline to Week 48
Loss of smell
Time Frame: Baseline to Week 48
Changes from baseline in scores of loss of smell at each evaluation time point.
Baseline to Week 48
Runny nose/postnasal drip
Time Frame: Baseline to Week 48
Change from baseline in scores of runny nose/postnasal drip at each evaluation time point.
Baseline to Week 48
Facial pain and/or pressure
Time Frame: Baseline to Week 48
Change from baseline in facial pain and/or pressure scores at each evaluation time point.
Baseline to Week 48
Total symptoms score (TSS)
Time Frame: Baseline to Week 48
Changes from baseline in TSS each evaluation time point.
Baseline to Week 48
Sino-nasal outcome test-22 (SNOT-22) scores
Time Frame: Baseline to Week 48
Changes from baseline in SNOT-22 scores at each evaluation time point.
Baseline to Week 48
Proportion of subjects exposed to SCS for acute exacerbation of chronic rhinosinusitis (AECRS) over 24 weeks.
Time Frame: Baseline to Week 24
Baseline to Week 24
Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone).
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-1905-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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