NCT05131464已完成2 期
An Open-label, Single-arm, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Keymed Biosciences Co.Ltd3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
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 CM310 in patients with CRSwNP.
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
- •The patient must be able to understand and voluntarily sign an ICF.
- •Participated in the clinical study of CM310 in patients with CRSwNP (Study No. of CM310NP001) and meet the criterion "a" or "b" as below:
- •Patients have completed the treatment as required by the protocol and completed the EOS (V12) visit;
- •Early withdrawal from the visit due to poor compliance or other objective reasons other than CM310-related AE, and the patient have completed early withdraw visit as per protocol, and, as assessed by the investigator and sponsor, the factors resulting in early termination of main study treatment have disappeared/will not affect the patient's participation in this extension study.
- •Patients must have received INCS at a relatively stable dose for at least 4 weeks upon the screening visit.
排除标准
- •Patients who are considered ineligible for continuous CM310 treatment by the investigator and the sponsor due to CM310-related* SAE or discontinuation caused by CM310-related* AE developed in the main study.
- •Patients who had poor compliance in the main study and are judged unable to complete this study by the investigator.
- •Not enough washing-out period for previous therapy.
- •Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
- •Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN) or serum creatinine level > ULN.
- •Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
研究组 & 干预措施
CM310
Experimental
干预措施: CM310 (Drug)
结局指标
主要结局
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
时间窗: approximately 2 years
Incidences of TEAE, SAE and AESI related to CM310; Abnormalities in laboratory tests, physical examination, vital sign and 12-lead electrocardiogram.
次要结局
- Changes from baseline in total scores of NPS and NCS in patients with a nasal polyp surgery history or complication with asthma at each evaluation time point.(approximately 2 years)
- PK endpoint: steady-state trough concentration (CtroughSS) of CM310.(approximately 2 years)
- Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point.(approximately 2 years)
- Changes from baseline in weekly average nasal congestion score (NCS) at each evaluation time point.(approximately 2 years)
- Changes from baseline in total nasal polyp score (NPS) from both sides at each evaluation time point.(approximately 2 years)
- PD endpoint: Changes from baseline in eosinophils levels in plasma and nasal polyp biopsy samples at each evaluation time point.(approximately 2 years)
- Immunogenicity endpoint: generation of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs).(approximately 2 years)
- Changes from baseline in patient's nasal total symptom score (TSS) at each evaluation timepoint.(approximately 2 years)
- Changes from baseline in Lund-Mackay score of sinus CT scan at each evaluation time point.(approximately 2 years)
- Percentage of patients receiving rescue therapy.(approximately 2 years)
- Changes from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at each evaluation time point.(approximately 2 years)
- Changes from baseline in three-dimensional sinus inflammation volume of sinus CT scan performed sat each evaluation time point.(approximately 2 years)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
2 期
The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal PolypsChronic Rhinosinusitis With Nasal PolypsNCT06015243Genrix (Shanghai) Biopharmaceutical Co., Ltd.70
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