Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis

Sanofi

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: placebo; Drug: SAR113945

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113333

TDU10820

U1111-1116-5630 (Other Identifier)

2009-017502-36 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

• Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.

Secondary Objective:

• Assess systemic exposure of SAR113945 following intra-articular delivery.

Full description

The total study duration per subject ranges from 4 to 20 weeks broken down as follows:

• screening within 4 weeks before dosing,
• follow-up of 4 weeks (28 days) after the single dose of study medication,
• prolonged by a maximum of 12 weeks if plasma PK level > Limit Of Quantification (LOQ) at Day 28.

Enrollment: 40 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:

  • X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,
  • Western Ontario MacMaster (WOMAC) score ≦ 72,
  • American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.

Exclusion criteria

• Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.
• Secondary osteoarthritis.
• Moderate/severe renal impairment.
• Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) > 3 Upper Limit of Normal range.
• Intra-articular injection within 3 months.
• Presence of local skin abnormality at the affected knee joint.
• Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.
• Any Investigational Product within 3 months.
• Any patient unlikely to comply with the requirements of the study.

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

---

40 participants in 2 patient groups, including a placebo group

SAR113945

Experimental group

Description:

SAR113945, single dose according to dose escalation design

Treatment:

Drug: SAR113945

Placebo

Placebo Comparator group

Description:

0.9% saline solution, single dose

Treatment:

Drug: placebo