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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01463488

Enrollment

Registered

2011-11-02

Start date

2011-11-30

Completion date

2012-08-31

Last updated

2012-08-23

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

Conditions

Knee Osteoarthritis

Brief 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.

Detailed 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.

Interventions

DRUGSAR113945

Pharmaceutical form:Injection Route of administration: Intra-articular

DRUGplacebo

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

\- 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.

Design outcomes

Primary

Measure	Time frame
Pain, Stiffness and Physical Function sub-scales from the WOMAC Index	during 24 weeks
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

Secondary

Measure	Time frame
Pharmacokinetics (Cmax)	during 24 weeks
Pharmacokinetics (AUC)	during 24 weeks
Pharmacokinetics (t1/2)	during 24 weeks
synovial fluid levels	during 24 weeks

Countries

Germany

Outcome results

None listed

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