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BMS-582949 and Methotrexate

Phase 2

Psoriasis | Small molecule | Dermatology |Bristol-Myers Squibb Company|Trials Updated: Dec 7, 2015

BMS-582949 and Methotrexate development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2005

BMS-582949 and Methotrexate target and mechanism

Molecular targetMAPK14
Target classInhibitor
ModalitySmall molecule

Also known as BMS-582949

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment325

FDA Designations

No designations recorded

BMS-582949 and Methotrexate clinical trials

BMS-582949 and Methotrexate · 4 trials · 4 indications

Phase 2 3Phase 1 1
NCT00570752Efficacy Study of p38 Kinase Inhibitor to Treat Patients With AtherosclerosisVascular Diseases
COMPLETED72 Analytics
NCT00605735PoC in Rheumatoid Arthritis With MethotrexateRheumatoid Arthritis, NOS
COMPLETED121 Analytics
NCT00399906A Study of BMS-582949 in Patients With Moderate to Severe Plaque PsoriasisPsoriasis
COMPLETED99 Analytics
PHASE2COMPLETED
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
Vascular DiseasesUnlock trial analytics
PHASE2COMPLETED
PoC in Rheumatoid Arthritis With Methotrexate
Rheumatoid Arthritis, NOSUnlock trial analytics
PHASE2COMPLETED
A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

FDG-PET signal of the carotid and/or ascending aorta
at 4 and 12 weeks
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
at Week 12
The primary endpoint is the proportion of subjects achieving an IGA score of clear or almost clear at Week 12
at Week 12
To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state
during 28 doses of treatment

Secondary Endpoints

Inflammatory and thrombotic biomarkers
will be measured throughout the 12 weeks of treatment
Proportion of subjects achieving an ACR 20
at each scheduled visit
Proportion of subjects schieving and ACR 50
at each scheduled visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo + background low to moderate dose statinACTIVE_COMPARATORPlacebo + background low to moderate dose statin Tablets, Oral, 0 mg, once daily, for 12 weeks
BMS-582949 + Background low to moderate dose statinEXPERIMENTALBMS-582949 + Background low to moderate dose statin Tablets, Oral, 100 mg, once daily for 12 weeks
AtorvastatinACTIVE_COMPARATORAtorvastatin Tablets, oral, 80 mg once daily for 12 weeks
A1EXPERIMENTAL -
P1PLACEBO_COMPARATOR -
A2ACTIVE_COMPARATOR30 mg
A3ACTIVE_COMPARATOR100 mg

Interventions

NameTypeDescription
PlaceboOTHER -
BMS-582949DRUG -
AtorvastatinDRUG -
StatinDRUG -
BMS-582949 and MethotrexateDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * History of documented atherosclerosis * LDL between 70 and 130 mg/dL * Patients receiving stable low- to moderate-dose statin * BMI 18-37 kg/m² * Must be able to swallow tablets * Must be able to medically tolerate the procedures, contrast medium, and medications involved Exc...

Countries:United StatesArgentinaCzechiaFranceMexicoSouth KoreaSpainTaiwanAustraliaCanada
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Frequently asked questions about BMS-582949 and Methotrexate

What is BMS-582949 and Methotrexate?

BMS-582949 is an investigational small molecule developed by Bristol-Myers Squibb. It has been studied in combination with methotrexate, a standard rheumatoid arthritis therapy, in clinical trials for rheumatoid arthritis. The combination was evaluated in a Phase 2 proof-of-concept study and a Phase 1 multiple ascending dose study.

What is BMS-582949 used for?

BMS-582949 has been studied for rheumatoid arthritis, psoriasis, and vascular diseases. It was tested both as monotherapy and with methotrexate background therapy. All trials were Phase 1 or Phase 2 and have been completed. It is not approved for any indication.

What does BMS-582949 target?

BMS-582949 targets MAPK14, also known as p38 alpha mitogen-activated protein kinase. It acts as an inhibitor of this enzyme. By inhibiting MAPK14, the drug aims to reduce inflammatory signaling, which is relevant to conditions such as rheumatoid arthritis and psoriasis.

Who makes BMS-582949?

BMS-582949 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the clinical trials evaluating the drug in rheumatoid arthritis, psoriasis, and vascular diseases.

What phase is BMS-582949 in?

BMS-582949 is in Phase 2 development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 proof-of-concept study in rheumatoid arthritis with methotrexate and a Phase 2 study in plaque psoriasis. It is investigational and has not been approved by the FDA.

What clinical trials is BMS-582949 in?

BMS-582949 has been evaluated in completed trials including NCT00605735, a Phase 2 study in rheumatoid arthritis with methotrexate; NCT00570752, a Phase 2 study in atherosclerosis; NCT00399906, a Phase 2 study in plaque psoriasis; and NCT00162292, a Phase 1 multiple ascending dose study in rheumatoid arthritis.