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

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: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Drug: SHR-1905 Injection; Drug: SHR-1905 Placebo Injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Huize Han; Phone Number: +0518-81220121; Email: huize.han@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye & ENT Hospital of Fudan University
      • Principal Investigator: Dehui Wang

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Nasal polyp scores (NPS)	Change from baseline in NPS at Week 24.	Baseline to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPS	Changes from baseline in NPS from baseline at each evaluation time point.	Baseline to Week 48
Nasal Congestion Scores (NCS)	Changes from baseline in NCS at each evaluation time point.	Baseline to Week 48
Loss of smell	Changes from baseline in scores of loss of smell at each evaluation time point.	Baseline to Week 48
Runny nose/postnasal drip	Change from baseline in scores of runny nose/postnasal drip at each evaluation time point.	Baseline to Week 48
Facial pain and/or pressure	Change from baseline in facial pain and/or pressure scores at each evaluation time point.	Baseline to Week 48
Total symptoms score (TSS)	Changes from baseline in TSS each evaluation time point.	Baseline to Week 48
Sino-nasal outcome test-22 (SNOT-22) scores	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.		Baseline to Week 24
Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone).		Baseline to Week 24

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps
• Other Study ID 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