NCT06015243尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Adverse events
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •the investigator judges that the subject may benefit from continued use of the test drug.
- •Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form
排除标准
- •Poor compliance in the GR1802-005 trial and in the judgment of the investigator is unable to complete this continuation trial;
- •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.
- •The time to first dosing in the extension trial program was greater than 4 weeks from the GR1802-005 study W16 visit;
- •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;
- •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;
- •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;
研究组 & 干预措施
Experimental: GR1802
Experimental
GR1802 injection 300mg every two weeks for 16-week treatment
干预措施: GR1802 injection (Drug)
结局指标
主要结局
Adverse events
时间窗: Baseline up to Week 24
to characterise the safety and tolerability of GR1802 injection, including abnormal vital signs, laboratory tests, electrocardiogram.
次要结局
- Change From Baseline at each evaluation time point in Nasal Polyp Score(Baseline up to Week 24)
- Change From Baseline at each evaluation time in Nasal Congestion/Obstruction Symptom(NCS) Severity Score(Baseline up to Week 24)
- Total Nasal Symptom Score(TNSS) score(Baseline up to Week 24)
- University of Pennsylvania Smell Identification Test (UPSIT)(Baseline up to Week 24)
- Visual Analogue Scale (VAS) for Rhinosinusitis(Baseline up to Week 24)
- Proportion of subjects receiving rescue therapy for nasal polyps(Baseline up to Week 24)
- Ctrough(Baseline up to Week 24)
- Vz/F(Baseline up to Week 24)
- CL/F(Baseline up to Week 24)
- Anti-drug antibodies(ADA)(Baseline up to Week 24)
研究者
相似试验
已完成
2 期
The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal PolypsChronic Rhinosinusitis With Nasal PolypsNCT05131464Keymed Biosciences Co.Ltd46
招募中
3 期
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUSAtypical Hemolytic Uremic SyndromeNCT05795140Novartis Pharmaceuticals65
已完成
3 期
A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01655381Hoffmann-La Roche15
已完成
3 期
A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisRheumatoid ArthritisNCT01772316Hoffmann-La Roche47
已完成
3 期
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926Rheumatoid ArthritisNCT01730456Hoffmann-La Roche13