Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)

23. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

470

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Biologisch: KN3835

Participants will receive KN3835 in Part 2 of the Study

Andere Namen:
  • EN3835
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Number of Participants with Adverse Events
Zeitfenster: Observational Day 1 up to Treatment/Retreatment Period Day 360
Observational Day 1 up to Treatment/Retreatment Period Day 360

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Observational Day 360
Up to Observational Day 360
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to Treatment/Retreatment Period Day 360
Up to Treatment/Retreatment Period Day 360

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Ermittler

  • Studienleiter: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

11. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

23. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2026

Zuerst gepostet (Tatsächlich)

29. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • KN3835-314 HMT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren