Clinical trial NCT05891483: Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.


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≥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.

Primary outcomes:
measure: Nasal polyp scores (NPS)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: NPS
timeFrame: Baseline to Week 48
measure: Nasal Congestion Scores (NCS)
timeFrame: Baseline to Week 48
measure: Loss of smell
timeFrame: Baseline to Week 48
measure: Runny nose/postnasal drip
timeFrame: Baseline to Week 48
measure: Facial pain and/or pressure
timeFrame: Baseline to Week 48
measure: Total symptoms score (TSS)
timeFrame: Baseline to Week 48
measure: Sino-nasal outcome test-22 (SNOT-22) scores
timeFrame: Baseline to Week 48
measure: Proportion of subjects exposed to SCS for acute exacerbation of chronic rhinosinusitis (AECRS) over 24 weeks.
timeFrame: Baseline to Week 24
measure: Dose of SCS used for AECRS over 24 weeks (converted to equivalent dose of prednisone).
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
state: Shanghai
Study officials:
References: