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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

SAR113945

placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 276001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR113945 - Dose 1

SAR113945 - Dose 2

SAR113945 - Dose 3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain, Stiffness and Physical Function sub-scales from the WOMAC Index

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

Secondary Outcome Measures

Pharmacokinetics (Cmax)

Pharmacokinetics (AUC)

Pharmacokinetics (t1/2)

synovial fluid levels

Full Information

NCT ID

NCT01463488

First Posted

October 29, 2011

Last Updated

August 22, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01463488

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR113945 - Dose 1

Arm Type

Experimental

Arm Title

SAR113945 - Dose 2

Arm Type

Experimental

Arm Title

SAR113945 - Dose 3

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SAR113945

Intervention Description

Pharmaceutical form:Injection Route of administration: Intra-articular

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form:Injection Route of administration: Intra-articular

Primary Outcome Measure Information:

Title

Pain, Stiffness and Physical Function sub-scales from the WOMAC Index

Time Frame

during 24 weeks

Title

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

Time Frame

during 24 weeks

Secondary Outcome Measure Information:

Title

Pharmacokinetics (Cmax)

Time Frame

during 24 weeks

Title

Pharmacokinetics (AUC)

Time Frame

during 24 weeks

Title

Pharmacokinetics (t1/2)

Time Frame

during 24 weeks

Title

synovial fluid levels

Time Frame

during 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 276001

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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