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

Knee Osteoarthritis Clinical Trial

Official title:

A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463488
• Other study ID #: TDU11685
• Secondary ID: 2011-003232-31U1
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2011
• Last updated: August 22, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• SAR113945
Pharmaceutical form:Injection Route of administration: Intra-articular
• placebo
Pharmaceutical form:Injection Route of administration: Intra-articular

Locations

Country	Name	City	State
Germany	Investigational Site Number 276001	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Stiffness and Physical Function sub-scales from the WOMAC Index		during 24 weeks	No
Primary	Number of patients reporting Adverse Events of special interest: tolerability at the site of injection and in the knee + other events reported by the patient		during 24 weeks	Yes
Secondary	Pharmacokinetics (Cmax)		during 24 weeks	No
Secondary	Pharmacokinetics (AUC)		during 24 weeks	No
Secondary	Pharmacokinetics (t1/2)		during 24 weeks	No
Secondary	synovial fluid levels		during 24 weeks	No