NCT07846280尚未招募3 期
A Phase 3, Multi-center Extension Study to Evaluate the Long-term Safety, Efficacy, and Maintenance of Response of KN3835 in the Treatment and Retreatment of Flexible/Semi-flexible Hammertoe
Endo USA Inc., a Keenova Therapeutics Company0 个研究点目标入组 470 人开始时间: 2026年10月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 470
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
The primary purpose of this study is to assess the long-term safety of treatment and retreatment with KN3835 for flexible/semi-flexible HMT.
详细描述
This extension study is for eligible participants who completed parent study KN3835-313 HMT. The study comprises 2 parts:
- Part I: a double-blind Observation Period from Observational Day 1 to Observational Day 360, and
- Part 2: an optional open-label Treatment/Retreatment Period from Observational Day 180 (Treatment/Retreatment Day 1) to Treatment/Retreatment Day 360 (End of Study).
研究设计
- 研究类型
- 干预性
- 分配方式
- 非随机
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 双盲 (受试者、研究者)
盲法说明
In Part 1 of the study, investigators and participants will remain blinded as per parent Study KN3835-313. Part 2 of the study will be open label.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Were enrolled in and completed Study KN3835-313 (participants who completed the study are those that completed the Day 57/End of Study Visit, were assessed for safety, and received at least 1 dose of study intervention).
- Has no significant medical history or examination findings related to the foot to be treated, which in the investigator's opinion, would make the participant unsuitable for study intervention administration or study required evaluations.
- If female, be of non-childbearing potential or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after treatment.
- Be willing and able to comply with all protocol required visits and assessments.
- Key
排除标准
- Has any significant medical condition, or a serious or severe event in the parent study or any ongoing event from the parent study, which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
- Has received or plans to receive surgical or nonsurgical treatments on the foot or toe that was treated for the duration of study participation.
- Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Observation then KN3835
Experimental
After observation during Part 1 of the study, participants will have the option to receive treatment or retreatment with KN3835 in Part 2.
干预措施: KN3835 (Biological)
Observation Only
No Intervention
Participants will be observed through Part 1. After completion of Part 1, participants will have the option to be observed only during Part 2 of the study.
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: Observational Day 1 up to Treatment/Retreatment Period Day 360
次要结局
- Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period(Baseline and up to Observational Day 360)
- Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 1 Observational Period(Baseline and up to Observational Day 360)
- Change from Baseline In Pain Intensity Numeric Rating Scale (NRS) Score In Part 1 Observational Period(Baseline and up to Observational Day 360)
- Percentage of Participants That Meet Retreatment/Treatment Criteria In Part 1 Observational Period(Observational Day 180)
- Percentage of Participants Reporting To Be "Quite Satisfied" and "Very Satisfied" On The Subject Satisfaction With Treatment Scale In Part 1 Observational Period(Up to Observational Day 360)
- Change from Baseline In Pain Intensity NRS Score In Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Percentage Participants with Investigator Reported "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the Clinician Global Impression of Change Scale (CGIC) Scale Score in Part 1 Observational Period(Up to Observational Day 360)
- Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period(Baseline and up to Observational Day 360)
- Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period(Baseline and up to Observational Day 360)
- Change from Baseline In The Patient Global Impression of Severity (PGIS) HMT Overall Scale Score in Part 1 Observational Period(Baseline and up to Observational Day 360)
- Percentage Of Participants reporting "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the Patient Global Impression of Change Scale (PGIC) HMT Overall Scale Score in Part 1 Observational Period(Up to Observational Day 360)
- Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Percentage of Participants Reporting To Be "Satisfied" and "Very Satisfied" On The Subject Satisfaction With Treatment Scale In Part 2 Treatment/Retreatment Period(Up to Treatment/Retreatment Period Day 360)
- Percentage Of Participants with Investigator Reported "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the CGIC HMT Overall Scale Score in Part 2 Treatment/Retreatment Period(Up to Treatment/Retreatment Period Day 360)
- Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Change from Baseline In The PGIS HMT Overall Scale Score in Part 2 Treatment/Retreatment Period(Baseline and up to Treatment/Retreatment Period Day 360)
- Percentage Of Participants reporting "Minimal Improvement", "Much Improvement", or "Very Much Improvement" on the PGIC HMT Overall Scale Score in Part 2 Treatment/Retreatment Period(Up to Treatment/Retreatment Period Day 360)
研究者
标识符
- NCT 编号
- NCT07846280
- 其他研究编号
- KN3835-314 HMT
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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