SHR-1905 injection for chronic rhinosinusitis with nasal polyps

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

This trial will test whether SHR-1905 injections help adults with chronic rhinosinusitis with nasal polyps reduce polyp size and symptoms compared with placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07132827 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial enrolls adults with bilateral nasal polyps and significant symptoms who will receive either SHR-1905 injection or a matching placebo. Outcomes will include symptom measures (such as SNOT-22 and nasal congestion score), nasal polyp score (NPS), and safety monitoring. Eligible participants must have NPS ≥5, NCS ≥2, SNOT-22 ≥30, weigh ≥40 kg, and have used intranasal corticosteroids; many will have prior surgery or systemic corticosteroid use. The study is sponsored by Guangdong Hengrui Pharmaceutical with the lead site listed as Eye & ENT Hospital of Fudan University in Shanghai.

Who should consider this trial

Good fit: Adults with bilateral CRSwNP who have significant symptoms (NPS ≥5, NCS ≥2, SNOT-22 ≥30), weigh at least 40 kg, have used intranasal corticosteroids, and may have prior nasal surgery or systemic corticosteroid use are ideal candidates.

Not a fit: Patients with mild disease or non-polyp chronic rhinosinusitis, those with comorbidities that affect nasal evaluation or eosinophil counts, uncontrolled hypertension or diabetes, immunodeficiency, recent infection, or who cannot undergo nasal endoscopy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, SHR-1905 could reduce nasal polyp size and symptoms and decrease the need for systemic steroids or surgery.

How similar studies have performed: Other biologic therapies targeting type 2 inflammation have shown benefit in Phase 3 trials for CRSwNP, so this approach builds on prior successes.

Eligibility criteria

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≥30 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) prior to randomization.
8. NP surgery in the past and/or SCS use within 1 years before screening(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 and/or uncontrolled diabetes.
6. Concomitant with infection within 4 weeks prior to randomization.
7. Uncontrolled epistaxis within 4 weeks prior to randomization.
8. Major surgery performed within 3 months prior to randomization, or surgery planned during the study, or treatments that may affect evaluations according to investigators.
9. Parasitic infection within 6 months before randomization.
10. 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.
11. Malignancies diagnosed within 5 years before randomization (except those with a low risk of metastasis or death).
12. Abnormalities of laboratory tests at screening or baseline.
13. Concomitant with active hepatitis B, positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, or positive treponema pallidum antibodies.
14. Prolonged QTc interval or other clinically significant abnormal results of ECG at screening or baseline that may cause significant safety risks to subjects.
15. FEV1 before the use of bronchodilator (pre-BD) was less than 50% at screening.
16. Transfusion of blood products or immunoglobulin within 4 weeks prior to randomization.
17. SCS or additional INCS use within 4 weeks before randomization, or planned use during treatment period.
18. Regular use of decongestants (local or systemic) within 4 weeks before randomization, except for during the endoscopic procedure.
19. Adnimistration of live vaccine or viral vector vaccine within 4 weeks before randomization.
20. Allergen immunotherapy within 8 weeks before randomization.
21. Smoking at screening, or smoking cessation less than 6 months at screening.
22. 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Eye & Ent Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: HuanHuan Huang

Conditions Chronic Rhinosinusitis With Nasal Polyps