Osteoarthritis of the knee MedDRA version: 9.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee
Conditions
Interventions
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 hu
Sponsors
Delenex Therapeutics AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated Informed Consent. • Male or female. • >= 40 years of age. • Body mass index = 60 mm on a 100 mm (linear) VAS at Screening. • Paracetamol and NSAIDs (apart from acetyl salicylic acid = 100 mg/day) must be withdrawn at least 24 hours prior to Screening (Day -7 [-3 days]). • Paracetamol, which is allowed to be re-initiated after completion of Screening assessments (Day -7 [-3 days]), must be withdrawn again as of Day -3. • Doses of “chondroprotective” agents containing glucosamine and/or chondroitin sulphate must be stable for at least 3 months prior to Screening. • Doses of any non-prescription medication claiming effects on signs or symptoms of OA (e.g., Rosa canina (lithocin), Perna canaliculus (“Grünlippenmuschelextrakt”), Harpagophytum procumbens (“Teufelskralle”)) must be stable for at least 3 months prior to Screening. • Use of non-pharmacological treatment modalities (e.g., physical therapy, biomechanical devices, magnetic therapy, ointments, and heating pads) must be stable for at least 3 months prior to Screening. • Negative QuantiFERON-TB Gold test. • Ability to comply with the study requirements 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Radiographic evidence of tibiofemoral OA within the last 6 months before Screening, consisting of Grade IV, according to Kellgren-Lawrence grading system. • Instability of the index knee joint of > 10° as assessed by goniometer at Screening. • Arthroscopic or open surgery to the index knee joint within 6 months prior to Screening. • Post-traumatic or any other secondary OA of the knee (e.g., hemochromatosis, severe chondrocalcinosis characterised by linear calcification of the hyaline cartilage, major knee trauma (e.g., rupture of cruciate ligaments, joint fractures)). • Relevant complex, radial or vertical meniscal tears if documented by pre-existing MRI scans. • Isolated OA of the patello-femoral joint. • Pain in the hip as assessed upon internal and external rotation of the hip joint that would confound measurement of the knee pain. • Co-morbidity that would confound measurement of knee pain (i.e., myopathy, spinal canal stenosis, radiculopathy) at Screening, if documented by pre-existing imaging. • More significant pain from the back than the knee that would confound measurement of knee pain. • Evidence of any inflammatory arthritis. • History of Reiter’s Syndrome, RA, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis, or any other inflammatory disease (immune mediated inflammatory disease) that may affect the knee. • Clinical signs or symptoms of active knee infection at Screening or Baseline. • Planned knee replacement during the course of the study. • Local or systemic contraindication for an i.a. injection at Screening or Baseline. • Treatment within 3 months prior to the injection with anticoagulant therapy. • Treatment within 3 months prior to Screening or concomitant treatment with neuroleptic agents, monoamine oxidase inhibitors, serotonin/norepinephrine re uptake inhibitor, tricyclic antidepressants, anticonvulsants, or anti-parkinsonian drugs, potent analgesic agents (i.e., opiates). • Treatment within 3 months prior to Screening or concomitant treatment with systemic corticosteroids. • Skin barrier breakdown (e.g., psoriasis) at the knee where the injection would take place at Screening or Baseline. • Any known sensitivity to E. coli derived products. • Any i.a. injection (corticosteroids, hyaluronic acid, etc.) within the 3 months prior to Screening. • History of high risk exposure to Mycobacterium tuberculosis. • Positive urine opiate test. • History of, or known current problems with drug or alcohol abuse at Screening. • History or suspicion of unreliability, poor cooperation or non-compliance with medical treatment at Screening. • HIV, hepatitis B or C infection. • Uncontrolled diabetes mellitus or cardiovascular disease (NYHA criteria III + IV), incl. uncontrolled hypertension (> 160/100 mmHg). • Active infectious episodes, or history of recurrent or chronic systemic infections. • Malignancy within 5 years prior to Screening, except for surgically-cured non melanoma skin cancer or cervical carcinoma in situ. • Significant haematological disease including leukopenia (total white blood cell count 3 x upper limit of normal in ALT and AST at Screening). • Received any live vaccine within 3 months prior to Screening. • Receiving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Secondary Objective: ;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. | — |
Countries
Germany
Outcome results
None listed