Osteoarthritis MedDRA version: 20.0 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: S201086
Product Code: S201086
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
Current Sponsor code: S201086
Other descriptive name: S201086
Concentration unit: mg milligr
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male patients or female patients of non-childbearing potential Age between 40 to 75 years (both inclusive) Body weight > 40 kg, body mass index (BMI) 50%) during the preceding month Symptoms severity defined by a pain = 40 mm and = 90 mm on VAS (100 mm) Documented need for symptomatic as needed-treatment for OA in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 502 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: Severe clinical knee malalignment according to the investigator Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side) Knee prosthesis already foreseen within the study period (whichever side) Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side) Previous osteotomy on the inferior limbs (whichever side) Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study Arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study Other pathologies affecting the knee Any contraindication to MRI including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of at least one dose (among 3 doses) of S201086 compared to placebo after 52 weeks of treatment in reducing cartilage loss measured by cartilage thickness using quantitative magnetic resonance imaging (qMRI) of the central medial tibiofemoral compartment (cMTFC) of the target knee.;Primary end point(s): Cartilage thickness of the central medial tibiofemoral compartment (cMTFC) of the target knee;Timepoint(s) of evaluation of this end point: Change from baseline to W052;Secondary Objective: To assess the safety and tolerability of 3 doses of S201086 To assess efficacy of 3 doses of S201086 versus placebo after 52 weeks of treatment on: - the proportion of structural progressors based on cartilage thickness using qMRI of the cMTFC of the target knee - pain, function, and stiffness measured with WOMAC - pain measured with a 100-mm VAS - patient global assessment (PGA) of disease activity measured with 100-mm VAS - reduction of cartilage loss measured by cartilage thickness using qMRI of the total tibiofemoral compartment (tTFC) of the target knee - Joint Space Width (JSW) measured by x-ray To assess efficacy of 3 doses of S201086 versus placebo after 28 and 52 weeks of treatment on bone area using qMRI of the medial femoral condyle surface of the target knee To assess the pharmacokinetics of S201086 To assess efficacy of 3 doses of S201086 versus placebo after 52 weeks of treatment on analgesic consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: Proportion of structural progressors based on cartilage thickness of the cMTFC of the target knee WOMAC subscales scores of the target knee for pain, function and stiffness Pain of the target knee PGA of disease activity of the target knee Proportion of Outcome Measures in Rheumatology (OMERACT)-OARSI responders Cartilage thickness of the total tibiofemoral compartment (tTFC) of the target knee Bone area of the medial femoral condyle surface of the target knee JSW of the target knee Analgesic consumption Safety endpoints: Adverse events Physical examination Body weight Vital signs Laboratory examinations ECG Pharmacokinetic parameters of S201086;Timepoint(s) of evaluation of this end point: Proportion of structural progressors based on cartilage thickness of the cMTFC of the target knee, cartilage thickness of the tTFC of the target knee, bone area of the medial femoral condyle surface of the target knee : W000, W028, W052 WOMAC subscales scores, PGA of disease activity of the target knee, proportion of OMERACT-OARSI responders: W000, W012, W028, W040, W052 Pain of the target knee: ASSE, W000, W004, W008, W012, W020, W028, W040, W052 JSW of the target knee: ASSE, W052 Analgesic consumption: all over the study Adverse events, Physical examination, Vital signs, Laboratory examinations: all over the study Body weight: ASSE, W000, W012, W028, W052 ECG: ASSE, W000, W004, W028, W052 Pharmacokinetic parameters of S201086: W004, W012, W028, W040, W052 | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Denmark, Hungary, Japan, Korea, Democratic People's Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, United States
Contacts
Public ContactDpto. Investigación y Desarrollo
Laboratorios Servier S.L.
Outcome results
None listed