Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
2026年9月23日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (推定)
470
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clinical Operations
- 電話番号：800-462-3636
- メール：clinicaltrials@endo.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants with Adverse Events
時間枠：Observational Day 1 up to Treatment/Retreatment Period Day 360
|
Observational Day 1 up to Treatment/Retreatment Period Day 360
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
時間枠：Baseline and up to Observational Day 360
|
Baseline and up to Observational Day 360
|
|
Change from Baseline In FFI Subscales (Difficulty, Pain and Activity Limitation) Scores In Part 1 Observational Period
時間枠：Baseline and up to Observational Day 360
|
Baseline and up to Observational Day 360
|
|
Change from Baseline In Pain Intensity Numeric Rating Scale (NRS) Score In Part 1 Observational Period
時間枠：Baseline and up to Observational Day 360
|
Baseline and up to Observational Day 360
|
|
Percentage of Participants That Meet Retreatment/Treatment Criteria In Part 1 Observational Period
時間枠：Observational Day 180
|
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
時間枠：Up to Observational Day 360
|
Up to Observational 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
時間枠：Up to Observational Day 360
|
Up to Observational Day 360
|
|
Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
時間枠：Baseline and up to Observational Day 360
|
Baseline and up to Observational Day 360
|
|
Percent Change from Baseline In Flexion Contracture As Measured By Goniometer in Part 1 Observational Period
時間枠：Baseline and up to Observational Day 360
|
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
時間枠：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
時間枠：Up to Observational Day 360
|
Up to Observational Day 360
|
|
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to Treatment/Retreatment Period Day 360
|
Up to Treatment/Retreatment Period Day 360
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Medical Director, MD、Endo USA Inc., a Keenova Therapeutics Company
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月11日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年9月23日
QC基準を満たした最初の提出物
2026年9月23日
最初の投稿 (実際)
2026年9月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月29日
QC基準を満たした最後の更新が送信されました
2026年9月23日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- KN3835-314 HMT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。