Chronic Rhinosinusitis With Nasal Polyps
Conditions
Brief 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
Detailed 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.
Interventions
DRUGGR1802 injection
150mg/1ml. 2 ml every two weeks Route of administration: Subcutaneous
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Baseline up to Week 24 | to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score | Baseline up to Week 24 | Change from baseline in the NCS score. NCS score (0-3), higher score means worse nasal symptom. |
| Total Nasal Symptom Score(TNSS) score | Baseline up to Week 24 | Change from baseline in TNSS score. TNSS score (0-9). Higher score means worse nasal symptom. |
| University of Pennsylvania Smell Identification Test (UPSIT) | Baseline up to Week 24 | Change from baseline in UPSIT. UPSIT score (0-40). Higher score means better sense of smell. |
| Visual Analogue Scale (VAS) for Rhinosinusitis | Baseline up to Week 24 | Change from baseline in VAS score. VAS score (0-10). Higher score means worse nasal symptom. |
| Change From Baseline at each evaluation time point in Nasal Polyp Score | Baseline up to Week 24 | NPS score ranges from 0-8. (sum of 0-4 for each nasal passage scores), higher score means a worse outcome. |
| Ctrough | Baseline up to Week 24 | PK parameter: trough concentration of GR1802 injection. and exposure（CL/F, Vz/F etc.） |
| Vz/F | Baseline up to Week 24 | PK parameter: The volume of distribution based on the terminal elimination phase adjusted by bioavailability. |
| CL/F | Baseline up to Week 24 | PK parameter: The apparent volume of the central compartment cleared of drug per unit time adjusted by bioavailability. |
| Anti-drug antibodies(ADA) | Baseline up to Week 24 | Incidence of ADA |
| Proportion of subjects receiving rescue therapy for nasal polyps | Baseline up to Week 24 | Rescue therapy includes Systemic Corticosteroids and endoscopic surgery |
Outcome results
None listed