- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05100225
Efficacy and Safety Trial of PTP-001 (MOTYS) for Symptomatic Knee Osteoarthritis
A Multiple Arm, Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New South Wales
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Botany, New South Wales, Australia, 2019
- Emeritus Research Sydney
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Broadmeadow, New South Wales, Australia, 2292
- Genesis Research Services
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Saint Leonards, New South Wales, Australia
- Royal North Shore Hospital
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Sydney, New South Wales, Australia, 2010
- Holdsworth House Medical Practice
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Victoria
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Camberwell, Victoria, Australia, 3124
- Emeritus Research Melbourne
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Quebec, Canadá, G1W 4R4
- Centrede Recherche Saint-Louis
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Ontario
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Hamilton, Ontario, Canadá, L8M 1K7
- Hamilton Medical Research Group
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Hamilton, Ontario, Canadá, L8N 4A6
- McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
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Toronto, Ontario, Canadá, M3J 0K2
- Canadian Phase Onward Inc.
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Quebec
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Québec, Quebec, Canadá, G1N4V3
- Diex Recherche Quebec Inc.
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Sherbrooke, Quebec, Canadá, J1L 0H8
- DIEX Recherche Sherbrooke Inc.
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Gandrup, Dinamarca, 9362
- Sanos Clinic Nordjylland
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Herlev, Dinamarca, 2730
- Sanos Clinic
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Vejle, Dinamarca, 7100
- Sanos Clinic Syddanmark
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female, aged 40 to 80 years
- Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3 (mild or moderate) as assessed by the central reading facility
- Target knee pain ≥ 20 and ≤ 40 out of 50 the WOMAC®NRS 3.1 pain questionnaire (sum of 5 questions) at screening and baseline
- Onset of symptomatic OA of the target knee was at least 6 months prior to screening
- Insufficient or failed response or intolerance to analgesics and/or non-steroidal anti-inflammatory drugs, as reported by the participant
IF FEMALE, must meet all of the following:
- Not breast feeding
- Not planning to become pregnant during the study
- If of childbearing potential, must have a negative pregnancy test result within 72 hours prior to receiving the intra-articular injection, and must commit to the use of a highly effective form of birth control (See Appendix A) for at least 12 weeks after the injection
- Willingness to remain on the same oral "rescue" (as needed) analgesic as the only pharmacologic treatment for knee pain during the study
- Willingness to abstain from taking any illicit or unauthorized medications for treatment of OA or any other concurrent condition during the study
- Written informed consent is obtained from the participant
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Participant is non-ambulatory (unable to walk >50 feet without assistance)
- Clinically severe obesity as defined by the National Institutes of Health (body mass target ≥40 kg/m2)
- Contralateral knee pain equal to or exceeding the pain in the target knee (on the WOMAC® NRS3.1 pain questionnaire) at screening and/or baseline
- Clinically significant effusion of the target knee at either the screening or baseline visits determined by physical examination (e.g., ballotable patella or positive bulge sign). Note: Participants presenting with effusion may be enrolled in the study after undergoing knee aspiration to remove excess fluid in the target joint.
- Severe (excessive) malalignment of the tibial-femoral axis, assessed radiographically
- Presence of active infection of the target knee or systemic infection requiring treatment within the 3 months prior to screening
- Clinical diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.) established by clinical history, examination, or serology
Participant is receiving, has received, or plans to receive any of the following therapies
- Prior administration of hyaluronic acid, extended release corticosteroid (e.g., Zilretta®), platelet-rich plasma (PRP), or stem cell therapies by intra-articular injection(s) of the target knee within 6 months prior to screening
- Prior intra-articular corticosteroid within 3 months prior to screening or into any other joint within 30 days prior to screening
- Current chronic systemic use of corticosteroids in doses exceeding 10 mg prednisolone-equivalents daily
- Treatment with any investigational therapy (drug, device, or biologic) within 3 months prior to screening or is planned for the duration of the study
- Treatment with immunosuppressive medication or chemotherapy within the past 5 years
- Chronic use of narcotics or alcohol abuse within the past 6 months prior to screening
- Surgery to the target knee (including arthroscopy) within 6 months prior to receiving the intra-articular injection or planned surgery to the target knee within 6 months after the injection
- Participant previously underwent arthroplasty of the target knee
- Presence of joint instability or complaints of locking, intermittent limitation in range of motion, or loose body sensation, suggestive of internal derangement of the knee (either extremity)
- Symptomatic OA of the non-target knee that is not responsive to paracetamol (acetaminophen) or oral nonsteroidal anti-inflammatory drugs (NSAIDs).
- Diagnosis of lower extremity gout or pseudo-gout in the past 6 months
- Osteonecrosis of either knee
- Significant acute (within the past 3 months) injury to the target knee
- History of receiving a solid organ or hematologic transplant
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years, except for basal or squamous cell carcinoma of the skin
- History of prior radiation therapy of the target knee
- History of autoimmune disease affecting the musculoskeletal system
- Known (documented) history of acquired immune deficiency syndrome or human immunodeficiency virus
- Any condition causing pain in or around the target knee (e.g., radiating pain, pain in another region of the ipsilateral lower extremity) that may interfere with assessment(s) of the target knee
- Other chronic pain anywhere in the body that requires the chronic use of analgesic medications, such as fibromyalgia, neuropathic pain, low back pain, etc.
- Presence of contraindications for use of 3 g/day of orally administered paracetamol/acetaminophen due to known hypersensitivity or hepatic impairment.
- Known presence of any concurrent medical condition (e.g., hematologic renal, hepatic, cardiac, or coagulation abnormalities) that in the investigator's judgment would interfere with the required study assessments and study participation
- Participant is involved in litigation (e.g., worker's compensation) for a medical condition or injury at any anatomical site
Plan de estudios
¿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 |
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Experimental: PTP-001 200 mg
A single intra-articular injection in the target knee of PTP-001 200 mg.
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Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
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Experimental: PTP-001 100 mg
A single intra-articular injection in the target knee of PTP-001 100 mg.
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Allogeneic human placental tissue particulate (PTP-001) is administered as a single intra-articular injection to the target knee after resuspension with saline.
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Comparador de placebos: Placebo/saline
A single intra-articular injection in the target knee of 4mL of placebo control - physiological saline (0.9% sodium chloride injection, USP).
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The placebo control, physiological saline (0.9% sodium chloride injection, USP), is administered as an intra-articular injection to the target knee.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Efficacy - Change from pretreatment baseline in the WOMAC pain subscale
Periodo de tiempo: At 6 months
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To evaluate the change from pretreatment baseline in the WOMAC pain sub-score in the target knee on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized on scales of 0-100.
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At 6 months
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Safety - Incidence of local and systemic AEs
Periodo de tiempo: Over 6 months
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To assess the long-term (6 months) incidence of local and systemic AEs, and consists of physical examination, laboratory values, AEs, AESI, and immunogenicity testing.
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Over 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from pretreatment baseline in pain intensity assessed by participant self report (WOMAC Pain subscale).
Periodo de tiempo: At 2 weeks, 3 months, 4 months, 5 months.
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WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function).
WOMAC A (measure of pain) is measured on an 11-box numerical rating scale, with categories from 0 (none) to 10 (extreme), normalized to a scale of 0-100, where higher score represents higher pain.
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At 2 weeks, 3 months, 4 months, 5 months.
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Change from pretreatment baseline in function assessed by participant self-report (WOMAC Function subscale).
Periodo de tiempo: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function).
WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher difficulties in physical function.
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Change from pretreatment baseline in the weekly average of daily pain assessed by patient self report (NRS).
Periodo de tiempo: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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The question is an average daily (24-h) pain intensity score on a 0 to 10 NRS scale with 0 indicating 'no pain' and 10 indicating 'pain as bad as you can imagine'.
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Change from pretreatment baseline in patient global assessment of OA (PGA-OA) assessed by participant self report.
Periodo de tiempo: At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Considering all the ways knee osteoarthritis affects the participants, the question is an average daily (24-h) self-reported global assessment on an 11-box numerical rating scale, with 0 indicating "very good" and 10 indicating "very poor".
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At 2 weeks, 3 months, 4 months, 5 months, and 6 months.
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Change from pretreatment baseline in participant self-reported quality of life measured by SF-36 overall score, PCS, and MCS.
Periodo de tiempo: At 3 months and 6 months.
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The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health, and has 2 summary scores (physical and mental). The physical health measure includes 4 scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). The assessment is performed on a scale of 0 (maximum disability)-100 (no disability) with higher scores indicating better health status. |
At 3 months and 6 months.
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Response to PTP-001 on the OMERACT-OARSI responder criteria.
Periodo de tiempo: At 2 weeks, 3 months, and 6 months.
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The OMERACT-OARSI responder criteria involve changes that are deemed to be clinically relevant in the three domains: pain, function, and Patient Global Assessment.
For each of these domains, ranges are defined for absolute and percent changes from baseline that correspond to "high improvement" and "moderate improvement".
OMERACT-OARSI response is defined as either i) improvement in pain or physical function ≥50% and an absolute change ≥20 mm on a 100-mm visual analog scale; or (2) improvement of ≥20% and with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment (PGA).
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At 2 weeks, 3 months, and 6 months.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Moin Khan, MD, McMaster University Department of Surgery St. Joseph's Healthcare Hamilton
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KOA-21-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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