Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part I

Sanofi

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: placebo; Drug: SAR113945

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463488

TDU11685/ACT12505 (Other Identifier)

2011-003232-31 (EudraCT Number)

TDU11685

U1111-1121-3831 (Other Identifier)

Details and patient eligibility

About

Study objectives:

• Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.
• Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.

Full description

• Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 168 days.

Enrollment: 24 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary knee osteoarthritis, based upon the following:

• X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
• Patients will be Kellgren and Lawrence classification II/III, and total Western Ontario McMaster (WOMAC) score 24 -72.
• Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.

Exclusion criteria

• Patients younger than 40 years
• Women of child bearing potential.
• Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level >30 IU/L.
• Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.
• Presence of local skin abnormality at the affected knee joint.
• Intra-articular injection within 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

SAR113945 - Dose 1

Experimental group

Treatment:

Drug: SAR113945

SAR113945 - Dose 2

Experimental group

Treatment:

Drug: SAR113945

SAR113945 - Dose 3

Experimental group

Treatment:

Drug: SAR113945

Placebo

Placebo Comparator group

Treatment:

Drug: placebo