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

NCT07132827 | Recruiting Phase 3

• 1 other identifier: SHR-1905-301
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Nasal polyp scores (NPS)

  Change from baseline in NPS at Week 24.

  Baseline to Week 24

• Nasal Congestion Scores (NCS)

  from baseline in NPS at Week 24.

  Baseline to Week 24

Secondary Outcomes (5)

• Lund Mackay score (LMK) from baseline on sinus CT scan

  Baseline to Week 24

• Loss of smell

  Baseline to Week 24

• Proportion of subjects with NPS≤1 point per nostril

  Baseline to Week 24

• Sino-nasal outcome test-22 (SNOT-22) scores

  Baseline to Week 24

• Total symptoms score (TSS)

  Baseline to Week 24

Study Arms (2)

SHR-1905 Injection

EXPERIMENTAL

Drug: SHR-1905 Injection

SHR-1905 Placebo Injection

PLACEBO COMPARATOR

Drug: SHR-1905 Placebo Injection

Interventions

SHR-1905 Injection DRUG

SHR-1905 Injection

SHR-1905 Injection

SHR-1905 Placebo Injection DRUG

SHR-1905 Placebo Injection

SHR-1905 Placebo Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Central Study Contacts

HuanHuan Huang

CONTACT

+0518-81220121; huanhuan.huang.hh30@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

CN (1)