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

NCT05891483 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-1905-202
• Study Type: interventional
• Target: 114
• 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), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Nasal polyp scores (NPS)

  Change from baseline in NPS at Week 24.

  Baseline to Week 24

Secondary Outcomes (9)

• NPS

  Baseline to Week 48

• Nasal Congestion Scores (NCS)

  Baseline to Week 48

• Loss of smell

  Baseline to Week 48

• Runny nose/postnasal drip

  Baseline to Week 48

• Facial pain and/or pressure

  Baseline to Week 48

Study Arms (4)

Treatment group A: SHR-1905 Injection（dose 1）

EXPERIMENTAL

Drug: SHR-1905 Injection

Treatment group B: SHR-1905 Injection（dose 2）

EXPERIMENTAL

Drug: SHR-1905 Injection

Treatment group C: SHR-1905 Injection（dose 3）

EXPERIMENTAL

Drug: SHR-1905 Injection

Placebo Group

PLACEBO COMPARATOR

Drug: SHR-1905 Placebo Injection

Interventions

SHR-1905 Injection DRUG

SHR-1905 Injection

Treatment group A: SHR-1905 Injection（dose 1）; Treatment group B: SHR-1905 Injection（dose 2）; Treatment group C: SHR-1905 Injection（dose 3）

SHR-1905 Placebo Injection DRUG

SHR-1905 Placebo Injection

Placebo Group

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≥20 at screening period and baseline.
• Recorded persistent NP symptoms for over 4 weeks prior to screening.
• Subjects received standard therapy with intranasal corticosteroids (INCS) and remained stable during the 4 weeks prior to randomization.
• NP surgery in the past and/or ACERS treated with SCS occurred within 2 years before randomization (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.
• Uncontrolled diabetes.
• Infection within 2 weeks prior to screening to randomization that is clinically significant and/or should be treated with systemic antibiotics.
• 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 (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.
• 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 (\>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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Eye & Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: May 25, 2023
• First Posted: June 7, 2023
• Study Start: September 4, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)