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SAR113945

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment178

FDA Designations

No designations recorded

Clinical trial landscape

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 Osteoarthritis
NCT01598415130
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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 114 trials (matched to "Knee Osteoarthritis")

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY3PHASE3Eloralintide
Pacira Biosciences, Inc.PCRX4PHASE3ZILRETTA
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE3NNC0487-0111
Bioventus, Inc. Class ABVS1PHASE2PTP-001
Enlivex Ltd.ENLV2PHASE1Allocetra
Smith & Nephew plc Sponsored ADRSNN9 - Undisclosed
Stryker CorporationSYK11N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH57N/AUndisclosed
Merit Medical Systems, Inc.MMSI1N/ACorticosteroid
Johnson & JohnsonJNJ1N/AUndisclosed
Abbott LaboratoriesABT1N/AUndisclosed
Enovis CorporationENOV1N/AUndisclosed
Teleflex IncorporatedTFX1 - Undisclosed
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Frequently asked questions about SAR113945

What is SAR113945 used for?

SAR113945 is an investigational small molecule being developed for osteoarthritis, specifically knee 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 listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug for knee osteoarthritis.

What phase is SAR113945 in?

SAR113945 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, with all three completed trials involving a total of 178 participants. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is SAR113945 in?

SAR113945 has completed three clinical trials: NCT01113333, a Phase 1 safety and pharmacokinetics study in German patients with knee osteoarthritis; NCT01463488, a Phase 1 study of single doses in German patients; and NCT01511549, a Phase 1 study in Japanese patients. A Phase 2 trial, NCT01598415, evaluated safety and efficacy of a new formulation in 130 patients.

Is SAR113945 the same as any other drug?

No alternative names for SAR113945 have been reported. The drug is identified solely by its code name SAR113945 in clinical trial registries and scientific literature. It is not known to be marketed under any brand name.