Study to Assess the Long-term Safety of KN3835 in the Treatment and Retreatment of Flexible/Semi-Flexible Hammertoe (HMT)
23 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
470
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Clinical Operations
- Número de teléfono: 800-462-3636
- Correo electrónico: clinicaltrials@endo.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
Participants will receive KN3835 in Part 2 of the Study
Otros nombres:
|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Participants with Adverse Events
Periodo de tiempo: Observational Day 1 up to Treatment/Retreatment Period Day 360
|
Observational Day 1 up to Treatment/Retreatment Period Day 360
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change from Baseline In Foot Function Index (FFI) Total Score In Part 1 Observational Period
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Observational Day 360
|
Up to Observational Day 360
|
|
Change from Baseline In FFI Total Score In Part 2 Treatment/Retreatment Period
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to Treatment/Retreatment Period Day 360
|
Up to Treatment/Retreatment Period Day 360
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Medical Director, MD, Endo USA Inc., a Keenova Therapeutics Company
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
11 de octubre de 2026
Finalización primaria (Estimado)
1 de diciembre de 2028
Finalización del estudio (Estimado)
1 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de septiembre de 2026
Publicado por primera vez (Actual)
29 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- KN3835-314 HMT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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