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

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: SHR-1905 Injection; Drug: SHR-1905 Placebo Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07132827

SHR-1905-301

Details and patient eligibility

About

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

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups, including a placebo group

SHR-1905 Injection

Experimental group

Treatment:

Drug: SHR-1905 Injection

SHR-1905 Placebo Injection

Placebo Comparator group

Treatment:

Drug: SHR-1905 Placebo Injection