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Recruiting NCT07132827

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

Phase III Interventional Chronic Rhinosinusitis With Nasal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1905 Injection, SHR-1905 Placebo Injection.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyps. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps

Overview

The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)

Interventions

  • Drug SHR-1905 Injection
    SHR-1905 Injection
  • Drug SHR-1905 Placebo Injection
    SHR-1905 Placebo Injection

Primary outcome measures

  • Nasal polyp scores (NPS) [Time frame: Baseline to Week 24]
  • Nasal Congestion Scores (NCS) [Time frame: Baseline to Week 24]
Secondary outcome measures (5)
  • Lund Mackay score (LMK) from baseline on sinus CT scan [Time frame: Baseline to Week 24]
  • Loss of smell [Time frame: Baseline to Week 24]
  • Proportion of subjects with NPS≤1 point per nostril [Time frame: Baseline to Week 24]
  • Sino-nasal outcome test-22 (SNOT-22) scores [Time frame: Baseline to Week 24]
  • Total symptoms score (TSS) [Time frame: Baseline to Week 24]

Eligibility criteria

Inclusion criteria

  • 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.
  • SNOT-22≥30 at screening period and baseline.
  • Recorded persistent NP symptoms for over 4 weeks prior to screening.
  • Subjects received standard therapy with intranasal corticosteroids (INCS) prior to randomization.
  • NP surgery in the past and/or SCS use within 1 years before screening(or with contraindications/ intolerances).

Exclusion criteria

  • 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.
  • Uncontrolled hypertension and/or uncontrolled diabetes.
  • Concomitant with infection within 4 weeks prior to randomization.
  • Uncontrolled epistaxis within 4 weeks prior to randomization.
  • Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
  • Parasitic infection within 6 months before randomization.
  • Sinus or intranasal surgery within 6 months prior to screening, or changes in the nasal walls caused by sinus or intranasal surgery that made NPS evaluation impossible.
  • Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
  • Abnormalities of laboratory tests at screening or baseline.
  • Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
  • Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
  • FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
  • Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
  • SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
  • Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
  • Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
  • Allergen immunotherapy within 8 weeks before randomization.
  • Smoking at screening, or smoking cessation less than 6 months at screening.
  • Substance abuse, drug abuse, and/or excessive alcohol consumption within 1 year prior to randomization.

Pregnancy (including positive pregnancy test at screening or baseline), lactation, or pregnancy plan during study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Eye & Ent Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT07132827 · SHR-1905-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗