Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511549
• Other study ID #: TDU11333
• Secondary ID: U1111-1121-4499
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2012
• Last updated: September 28, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Secondary Objective:

To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Description:

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: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Japanese male or female patients, aged 40 years or older, with knee osteoarthritis

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

• X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation

• Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72

• Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis

Exclusion criteria:

• Women of child bearing potential

• 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, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy

• Presence of local skin abnormality at the affected knee joint

• Any patient who received intra-articular injection within 3 months prior to administration

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:
• placebo
Pharmaceutical form:injection Route of administration: intra-articular
• SAR113945
Pharmaceutical form:injection Route of administration: intra-articular

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Osaka-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)		up to 24 weeks	Yes
Primary	Examination of skin/soft tissue of injected knee, and knee joint	Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe.; Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.	up to 24 weeks	Yes
Secondary	Pharmacokinetic parameter (AUC)		21 time points up to 24 weeks	No
Secondary	Pharmacokinetic parameter (Cmax)		21 time points up to 24 weeks	No
Secondary	Pharmacokinetic parameter (tmax)		21 time points up to 24 weeks	No
Secondary	Pharmacokinetic parameter (t1/2)		21 time points up to 24 weeks	No
Secondary	Pharmacodynamic parameter (WOMAC index)		up to 24 weeks	No
Secondary	Pharmacodynamic parameter (biomarkers relating to osteoarthritis)		up to 24 weeks	No