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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01511549

Enrollment

Registered

2012-01-18

Start date

2012-01-31

Completion date

2012-09-30

Last updated

2012-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief 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

Detailed description

Following the single dose of study medication, the study period for each patient will be 168 days.

Interventions

DRUGplacebo

Pharmaceutical form:injection Route of administration: intra-articular

DRUGSAR113945

Pharmaceutical form:injection Route of administration: intra-articular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)	up to 24 weeks	—
Examination of skin/soft tissue of injected knee, and knee joint	up to 24 weeks	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.

Secondary

Measure	Time frame
Pharmacokinetic parameter (tmax)	21 time points up to 24 weeks
Pharmacokinetic parameter (t1/2)	21 time points up to 24 weeks
Pharmacokinetic parameter (AUC)	21 time points up to 24 weeks
Pharmacodynamic parameter (biomarkers relating to osteoarthritis)	up to 24 weeks
Pharmacodynamic parameter (WOMAC index)	up to 24 weeks
Pharmacokinetic parameter (Cmax)	21 time points up to 24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026