A double-blind, randomised placebo-controlled

INTERVENTION: Product Name: ESBA105 Product Code: ESBA105 Pharmaceutical Form: Solution for injection Current Sponsor code: ESBA105 Other descriptive name: humanised single‐chain (scFv) antibody directed against human TNF‐alpha Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 0.16‐0.24 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use Product Name: ESBA105 Product Code: ESBA105 Pharmaceutical Form: Solution for injection Current Sponsor code: ESBA105 Other descriptive name: humanised single‐chain (scFv) antibody directed against human TNF‐alpha Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 0.9‐1.1 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use Product Name: ESBA105 Product Code: ESBA105 Pharmaceutical Form: Solution for injection Current Sponsor code: ESBA105 Other descriptive name: humanised single‐chain (scFv) antibody directed against human TNF‐alpha Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 4.5‐5.5 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use Product Name: ESBA105 Product Code: ESBA105 Pharmaceutical Form: Solution for injection Current Sponsor code: ESBA105 Other descriptive name: humanised single‐chain (scFv) antibody directed against human TNF‐alpha Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 9.0‐11.0 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intraarticular use CONDITION: Osteoarthritis of the knee ; MedDRA version: 9.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee PRIMARY OUTCOME: Main Objective: Part A; • To investigate the safety and tolerability of ESBA105 administered by intraarticular injection into the osteoarthritic knee joint; • To determine the systemic exposure to ESBA105 upon intra‐articular injection into the osteoarthritic knee joint; • To determine the appropriate doses of ESBA105 for Part B of the study; ; Part B; • To investigate the safety and tolerability of ESBA105 administered by intraarticular injection into the osteoarthritic knee joint; • To determine the systemic exposure to ESBA105 upon intra‐articular injection into the osteoarthritic knee joint; • To evaluate the extent and explore the duration of effect on signs and symptoms of osteoarthritis of the knee of two different doses of ESBA105; Primary end point(s): Primary efficacy endpoint is the change from Baseline (Day 0) to Day 7 in Visual Analogue Scale (VAS) to assess the intensity of knee pain. The VAS pain intensity score will be determined by measuring the change in millimetres on a 100 mm scale, as indicated by the patient marks. Secondary Objective: INCLUSION CRITERIA: • Signed and dated Informed Consent. • Male or female. • >= 40 years of age. • Body mass index < 30. • Negative pregnancy test for females of child bearing potential (pre‐menopausal, < 2 years post‐menopausal, not surgically sterile). Female patients of childbearing potential and their partners must to use 2 forms of contraception (including 1 barrier method), from screening until 2 months after the injection with ESBA105. Primary forms of contraception include intrauterine devices, oral contraceptive agents that the patient has already been using for at least 90 days before screening, and injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms, and cervical caps. • Patients with diagnosed OA of the knee (unilateral or bilateral) according to the American College of Rheumatology (ACR) Criteria for classification of idiopathic OA (clinical and radiological criteria)