E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
osteoarthritis |
osteoartritis |
|
E.1.1.1 | Medical condition in easily understood language |
osteoarthritis |
osteoartritis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate knee structure changes |
Evaluar cambios en estructura de la rodilla |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate changes from baseline in OA pain - To evaluate changes from baseline in physical function - To evaluate changes from baseline the cartilage structure -To evaluate changes from baseline in physical function -To evaluate structural progression - To evaluate safety and tolerability of the various LNA043 regimens |
- Evaluar los cambios respecto a la basal en el dolor por OA -Evaluar los cambios respecto a la basal en la función física -Evaluar los cambios estructurales respecto a la basal en la estructura del cartilago -Evaluar los cambios respecto a la basal en la evaluación de la función física -Evaluar la progresión estructural -Evaluar la seguridad y tolerabilidad de las distintas pautas posológicas de LNA043. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Males and females between 40 and 75 years of age -Body mass index (BMI) < 40 kg/m2 -Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria -and other criteria as specified by the protocol |
•Pacientes de ambos sexos entre 40 y 75 años de edad. • Índice de masa corporal (IMC) <40 kg/m2. • Diagnóstico de OA primaria de rodilla que afecta al compartimento tibiofemoral según los criterios clínicos y radiográficos del Colegio Estadounidense de Reumatología (ACR). para mas criterios consultar protocolo |
|
E.4 | Principal exclusion criteria |
-Participants with radiographic knee OA K-L grade = 4 on the non-target knee -Arthroscopy of the target knee within the 6 months prior to Screening -Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/μL -and other criteria as specified by the protocol |
•Participantes con OA de grado radiológico de K-L = 4 en la rodilla no afectada. • Artroscopia de la rodilla afectada durante los 6 meses anteriores a la selección. • Hemoglobina <8.5 g/dL (85 g/L) o recuento de plaquetas <100,000/μL para mas criterios consultar protocolo
. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in the knee structure |
Cambio respecto a la basal en la estructura de la rodilla |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0 to Week 104 |
semana 0 a semana 104 |
|
E.5.2 | Secondary end point(s) |
-Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain -Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function - Change from baseline in cartilage structure - Change from baseline in physical function - Proportion of participants demonstrating structural progression - Assessing adverse events and serious adverse events |
-Cambio en dolor con respecto a la basal del índice WOMAC -Cambio en la función con respecto a la basal del índice WOMAC - Cambio respecto a la basal en la estructura del cartílago - Cambio respecto a la basal en la función física - Proporción de pacientes que demuestren progresión estructural - Evaluar efectos adversos y efectos adversos graves . |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 - Week 0 to Week 104 |
-semana 0 a semana 104 -semana 0 a semana 104 -semana 0 a semana 104 -semana 0 a semana 104 -semana 0 a semana 104 -semana 0 a semana 104 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 39 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
China |
India |
Japan |
Mexico |
Taiwan |
United States |
Austria |
Denmark |
Estonia |
Germany |
Hungary |
Lithuania |
Poland |
Spain |
United Kingdom |
Czechia |
Argentina |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 22 |