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SAR113945

Phase 2

Knee Osteoarthritis | Small molecule | Musculoskeletal |Sanofi|Trials Updated: Oct 17, 2014

SAR113945 development status

Highest phase Phase 2
Registered trials 4 across 1 sponsor since Apr 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment218

FDA Designations

No designations recorded

SAR113945 clinical trials

SAR113945 · 4 trials · 2 indications

Phase 2 1Phase 1 3
NCT01598415Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part IIKnee Osteoarthritis
COMPLETED130 Analytics
PHASE2COMPLETED
Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II
Knee OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Womac Pain Score (5 items)
at 8 weeks
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.

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
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee
4 weeks up to a maximum of 12 weeks

Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.

Examination of knee joint of injected knee
4 weeks up to a maximum of 12 weeks

Any reaction is classified as effusion/worsening of effusion, warm and pain.

Secondary Endpoints

Womac Pain Score (5 items)
during 24 weeks
Womac Total Score (24 items)
during 24 weeks
Womac Stiffness (2 items)
during 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR113945EXPERIMENTALTDU11685 selected dose
PlaceboPLACEBO_COMPARATOR -
Dose 1EXPERIMENTALSAR113945 low dose
Dose 2EXPERIMENTALSAR113945 medium dose
Dose 3EXPERIMENTALSAR113945 high dose
SAR113945 - Dose 1EXPERIMENTAL -
SAR113945 - Dose 2EXPERIMENTAL -
SAR113945 - Dose 3EXPERIMENTAL -

Interventions

NameTypeDescription
SAR113945DRUGPharmaceutical form:Injection Route of administration: Intra-articular
placeboDRUGPharmaceutical form:Injection Route of administration: Intra-articular
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

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 Wester...

Countries:GermanyJapan
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Competitive Landscape -Osteoarthritis 143 trials (matched to "Knee Osteoarthritis")

Frequently asked questions about SAR113945

What is SAR113945 used for?

SAR113945 is an investigational small molecule being developed for knee osteoarthritis and osteoarthritis. It is administered intra-articularly, meaning directly into the knee joint. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes SAR113945?

SAR113945 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol SNY. Sanofi has conducted multiple clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug in patients with knee osteoarthritis.

What phase is SAR113945 in?

SAR113945 is in Phase 2 clinical development. The drug has completed three Phase 1 trials and one Phase 2 trial, all of which are finished. No active trials are currently ongoing for SAR113945, and it remains an investigational agent that is not yet approved for any use.

What clinical trials has SAR113945 been in?

SAR113945 has been studied in four completed clinical trials. These include NCT01113333, NCT01463488, and NCT01511549, which were Phase 1 studies, and NCT01598415, a Phase 2 study. The trials enrolled a total of 178 patients with knee osteoarthritis or osteoarthritis, conducted in Germany and Japan.

How is SAR113945 administered?

SAR113945 is administered via intra-articular injection, meaning it is injected directly into the knee joint. This route of administration is used in the clinical trials for knee osteoarthritis to deliver the drug locally to the affected area. The drug is being tested as a potential treatment for osteoarthritis.

Is SAR113945 the same as any other drug?

SAR113945 is the sole name provided for this investigational drug, with no alternative names listed. It is a distinct small molecule being developed by Sanofi for knee osteoarthritis. As it is still in clinical development, it does not have a brand name or generic name yet.