Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
2026년 9월 23일 업데이트: Endo USA Inc., a Keenova Therapeutics Company
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
The primary purpose of this study is to assess the long-term safety of treatment and retreatment with KN3835 for flexible/semi-flexible HMT.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (추정된)
470
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Clinical Operations
- 전화번호: 800-462-3636
- 이메일: clinicaltrials@endo.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Observation then KN3835
After observation during Part 1 of the study, participants will have the option to receive treatment or retreatment with KN3835 in Part 2. |
Participants will receive KN3835 in Part 2 of the Study
다른 이름들:
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간섭 없음: Observation Only
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Number of Participants with Adverse Events
기간: Observational Day 1 up to Treatment/Retreatment Period Day 360
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Observational Day 1 up to Treatment/Retreatment Period Day 360
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
기간: Baseline and up to Observational Day 360
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Baseline and up to Observational Day 360
|
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Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 1 Observational Period
기간: Baseline and up to Observational Day 360
|
Baseline and up to Observational Day 360
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Change from Baseline In Pain Intensity Numeric Rating Scale (NRS) Score In Part 1 Observational Period
기간: Baseline and up to Observational Day 360
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Baseline and up to Observational Day 360
|
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Percentage of Participants That Meet Retreatment/Treatment Criteria In Part 1 Observational Period
기간: Observational Day 180
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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
기간: Up to Observational Day 360
|
Up to Observational Day 360
|
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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
기간: Up to Observational Day 360
|
Up to Observational Day 360
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Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
기간: Baseline and up to Observational Day 360
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Baseline and up to Observational Day 360
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Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
기간: Baseline and up to Observational Day 360
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Baseline and up to Observational Day 360
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Change from Baseline In The Patient Global Impression of Severity (PGIS) HMT Overall Scale Score in Part 1 Observational Period
기간: Baseline and up to Observational Day 360
|
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
기간: Up to Observational Day 360
|
Up to Observational Day 360
|
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Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
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
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
Baseline and up to Treatment/Retreatment Period Day 360
|
|
Change from Baseline In Pain Intensity NRS Score In Part 2 Treatment/Retreatment Period
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
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
기간: Up to Treatment/Retreatment Period Day 360
|
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
기간: Up to Treatment/Retreatment Period Day 360
|
Up to Treatment/Retreatment Period Day 360
|
|
Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 2 Treatment/Retreatment Period
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
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
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
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
기간: Baseline and up to Treatment/Retreatment Period Day 360
|
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
기간: Up to Treatment/Retreatment Period Day 360
|
Up to Treatment/Retreatment Period Day 360
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 11일
기본 완료 (추정된)
2028년 12월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 9월 23일
QC 기준을 충족하는 최초 제출
2026년 9월 23일
처음 게시됨 (실제)
2026년 9월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 23일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KN3835-314 HMT
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
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