Clinical trial NCT06015243: The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Change From Baseline at each evaluation time point in Nasal Polyp Score
timeFrame: Baseline up to Week 24
measure: Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score
timeFrame: Baseline up to Week 24
measure: Total Nasal Symptom Score(TNSS) score
timeFrame: Baseline up to Week 24
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: Baseline up to Week 24
measure: Visual Analogue Scale (VAS) for Rhinosinusitis
timeFrame: Baseline up to Week 24
measure: Proportion of subjects receiving rescue therapy for nasal polyps
timeFrame: Baseline up to Week 24
measure: Ctrough
timeFrame: Baseline up to Week 24
measure: Vz/F
timeFrame: Baseline up to Week 24
measure: CL/F
timeFrame: Baseline up to Week 24
measure: Anti-drug antibodies(ADA)
timeFrame: Baseline up to Week 24
Other outcomes:
Locations:
Study officials:
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