The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of GR1802 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015243
• Other study ID #: GR1802-010
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 18, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: August 2023
• Source: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single-arm, multicenter, extension study to evaluate the long-term safety and efficacy of GR1802 injection in patients with Chronic Rhinosinusitis With Nasal Polyps

Description:

This trial was designed as an open, extension trial with the primary objective of evaluating the safety of long-term administration of GR1802 injection in patients with chronic rhinosinusitis with nasal polyps, and to a lesser extent, also evaluating the efficacy, immunogenicity, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participation in a clinical study of GR1802 injection for the treatment of chronic rhinosinusitis with nasal polyps (Protocol No. GR1802-005) and fulfillment of the following: completion of prescribed treatment as required by the protocol and completion of the W16 visit.

2. the investigator judges that the subject may benefit from continued use of the test drug.

3. Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form

Exclusion Criteria:

1. Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial;

2. Use of any protocol-specified prohibited medication/treatment during the GR1802-005 trial and prior to the first dose of this study that, in the judgment of the investigator, makes continued participation in the continuation trial unsuitable.

3. The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit;

4. Nasal polyp scoring is not available for nasal polyp scores for nasal or sinus surgery (e.g., nasal polypectomy, balloon dilatation, or intranasal stent placement) that was performed prior to the first administration of the drug in the extension trial that alters the structure of the nasal sidewall;

5. Individuals who have received live/attenuated vaccination within 8 weeks prior to the first dose of the extension trial or who plan to receive live/attenuated vaccination during the trial;

6. Any serious progressive or poorly controlled concomitant disease (e.g., asthma exacerbation requiring adjustment of background medication) identified during the GR1802-005 study period for which, in the judgment of the Principal Investigator, the subject is considered unsuitable for participation in the trial;

7. Other.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.	Baseline up to Week 24
Secondary	Change From Baseline at each evaluation time point 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.	Baseline up to Week 24
Secondary	Change From Baseline at each evaluation time 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.	Baseline up to Week 24
Secondary	Total Nasal Symptom Score(TNSS) score	Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom.	Baseline up to Week 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.	Baseline up to Week 24
Secondary	Visual Analogue Scale (VAS) for Rhinosinusitis	Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom.	Baseline up to Week 24
Secondary	Proportion of subjects receiving rescue therapy for nasal polyps	Rescue therapy includes Systemic Corticosteroids and endoscopic surgery	Baseline up to Week 24
Secondary	Ctrough	PK parameter: trough concentration of GR1802 injection. and exposure(CL/F, Vz/F etc.)	Baseline up to Week 24
Secondary	Vz/F	PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability.	Baseline up to Week 24
Secondary	CL/F	PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability.	Baseline up to Week 24
Secondary	Anti-drug antibodies(ADA)	Incidence of ADA	Baseline up to Week 24