A Controlled Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
9 de septiembre de 2026 actualizado por: IBSA Institut Biochimique SA
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single Intra-Articular Injection of a Solution of High and Low Molecular Weight Sodium Hyaluronate (HL-01) in the Treatment of Pain in Symptomatic Knee Osteoarthritis
The goal of this clinical trial is to test HL-01 in patients with knee osteoarthritis pain. The main question[s] it aims to answer are:
- Measure the change in average daily knee pain intensity scores from baseline to the end of the study using a pain scale that measures pain on a scale of 0 to 10
- Measure the change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scales measuring knee pain, stiffness, and function from baseline to the end of the study
- Measure the change in EuroQol EQ-5D-5L quality of life assessments from baseline to end of the study
- Measure change of participant and physician assessment of how the target knee pain and function are affected by the condition from baseline to end of the study
- Measure how often rescue medication is taken from baseline to end of the study
- Assess how well participants tolerate the study medication injection (investigational drug or placebo)
- Assess whether there are any adverse reactions or side effects from the study medication injection
Participants will be asked to complete the following:
- Provide informed consent
- Knee X-ray of target knee
- Complete physical health assessments (e.g., target knee assessment, height, weight, physical exam) at several timepoints throughout the study
- Provide demographic information and their medical/surgical history
- Provide blood and urine samples at several timepoints throughout the study
- Injection of study medication (investigational drug or placebo)
Complete electronic diaries for the following:
- Record average daily knee pain intensity scores during screening to confirm eligibility for the study
- Record average daily knee pain intensity scores after receiving the study medication injection until they complete the study
- Complete WOMAC scales assessing knee pain, stiffness, and function at baseline, Week 6, Week 12 and/or the end of the study
- Complete EuroQol EQ-5D-5L quality of life assessments at baseline, Week 6, Week 12 and/or the end of the study
- Complete global assessment of how the target knee pain and function are affected by the condition at baseline, Week 6, Week 12 and/or the end of the study
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
704
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: Marta Bignamini
- Número de teléfono: +4 158 360 1666
- Correo electrónico: marta.bignamini@ibsa.ch
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age is between 40 and 80 years of age
- Have symptoms of knee osteoarthritis (OA) for at least 6 months
- Meet American College of Rheumatology criteria (clinical and radiological) for knee OA
- Body mass index (BMI) is less than or equal to 40 kg/m2
- Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3
- Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications
- The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees
- Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study
- Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study
- Must use a highly effective birth control method if sexually active
Exclusion Criteria:
- Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details.
- Have active infections or target knee conditions that may compromise study drug administration
- Have exclusionary lab values determined during Screening
- Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee
- Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions
- Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety
- Received another clinical trial therapy, medication, or product with 90 days of Screening
- Have non-compliance with study diaries during Screening
- Involved in litigation, disability, or worker's compensation matters based on OA pain
- Allergic to study drug, HA, placebo, or acetaminophen
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: High and Low Molecular Weight Sodium Hyaluronate (HL-01)
Patients will receive single intra-articular knee injection of 3.36% HL-01.
|
Sodium hyaluronate solution, 3.36%, for intra-articular injection.
|
|
Comparador de placebos: Sterile buffered solution
Patients randomized to placebo will receive single intra-articular knee injection of 3.36% sterile buffered solution (sodium chloride).
|
Sodium chloride, for intra-articular injection.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline of the average daily pain intensity score.
Periodo de tiempo: From Baseline to Week 12
|
The average daily (24 hour) pain intensity score will be measured on a numeric rating scale (NRS) ranging from 0 to 10.
The Baseline value will be the mean of the daily records over the 7-day period before Day 1.
|
From Baseline to Week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Periodo de tiempo: Baseline to Week 12.
|
Change in WOMAC function subscale from Baseline to Week 12.
|
Baseline to Week 12.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
30 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Publicado por primera vez (Actual)
15 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24US-Hai08
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
producto fabricado y exportado desde los EE. UU.
No
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