The Study of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

A Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy, Safety of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873803
• Other study ID #: GR1802-005
• Status: Recruiting
• Phase: Phase 2
• Start date: February 8, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: Zhang Luo, PhD.
• Phone: 01065141136
• Email: dr.luozhang[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). Patients will receive GR1802 injection or Placebo every 2 Weeks.

Description:

This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the preliminary efficacy and safety of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps.

The study consists of a Screening/run-in Period (up to 4 weeks), a Randomized, Double Blind Treatment Period (16 weeks) and a Safety Follow-up Period (8 weeks).

70 subjects will be randomized 1:1 into the 300 mg first dose doubling Q2W group and the placebo Q2W group. Throughout the dosing period, all subjects continued treatment with standard therapy at a stable dose.

Patient-reported outcome including Nasal congestion score will be collected using patient diary. Central reading will be implemented to Nasal endoscopic nasal polyp score (NPS) and nasal polyp biopsy tissue analysis to eosinophil counts & percentage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Bilateral CRSwNP with prior treatment with systemic corticosteroids (SCS), and/or contraindicate to or intolerance to SCS, and/or with prior surgery to nasal polyps

2. Bilateral NPS of =5 with a minimum score of 2 in each nasal cavity at screening and at baseline.

3. Ongoing symptoms of nasal congestion/obstruction(NCS score of 2 or 3 at screening and at baseline).

4. Recorded use of intranasal corticosteroids for at least 4 weeks before screening

Exclusion Criteria:

1. Insufficient washout time for drugs that have an impact on the evaluation of efficacy and safety?

2. Concurrent disease that may interfere with the evaluation of safety and efficacy in subjects, or affect the risk- benefit evaluation of subjects. eg. specific ongoing nasal diseases, severe asthma, active infection, Severe cardiovascular disease, Severe laboratory test abnormalities.

3. Other.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Biological:
• GR1802 injection
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
• placebo
0mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline at Week 16 in Nasal Congestion/Obstruction Symptom(NCS) Severity Score	Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom.	at Week 16
Primary	Change From Baseline at Week 16 in Nasal Polyp Score	NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome.	at Week 16
Secondary	Time to the first response of NPS	Time to the first response of NPS (defined as bilateral endoscopic NPS improved =1).	Baseline up to Week 24
Secondary	Lund-Mackay score	Change from baseline in the Lund-Mackay score on CT scan. The range of LM score is 0-24. Higher score means worse rhinosinusitis.	at Week 16
Secondary	Bilateral endoscopic NPS	Change from baseline in the bilateral endoscopic NPS at Week 4, 8, 12, 24.	at Week 4, 8, 12, 24
Secondary	Nasal Congestion/Obstruction Symptom score(NCS)	Change from baseline in NCS at Week 4, 8, 12, 24.	at Week 4, 8, 12, 24
Secondary	University of Pennsylvania Smell Identification Test (UPSIT)	Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell.	at Week 16
Secondary	Total Nasal Symptom Score(TNSS) score	Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.	at Week 16
Secondary	Visual Analogue Scale (VAS) for Rhinosinusitis	Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.	at Week 16
Secondary	Proportion of subjects receiving rescue therapy for nasal polyps	Rescue therapy includes Systemic Corticosteroids and endoscopic surgery	Baseline up to Week 24
Secondary	Pharmacokinetics(PK)	Plasma concentration of GR1802 injection. PK parameter including trough concentration and exposure(CL/F, Vz/F etc.)	Baseline up to Week 24
Secondary	Pharmacodynamics(PD)	Change from baseline in serum biomarker level (Periostin, TARC, total IgE and eosinophil level) and biomarkers in nasal secretions and nasal exfoliated cells?	at Week 16
Secondary	Anti-drug antibodies(ADA)	Incidence of ADA	Baseline up to Week 24
Secondary	Safety parameters	Incidence of treatment-emergent adverse events (TEAEs), of treatment-emergent serious AEs (TESAEs), etc.	Baseline up to Week 24