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BMS-582949

Phase 2

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

BMS-582949 · 3 trials · 3 indications

Phase 2 3
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

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 -
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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

What is BMS-582949 used for?

BMS-582949 is an investigational small molecule being studied for the treatment of psoriasis, rheumatoid arthritis, and vascular diseases such as atherosclerosis. It has been evaluated in clinical trials for these conditions, though it is not approved and remains in clinical development.

What does BMS-582949 target?

BMS-582949 is a p38 kinase inhibitor, as indicated in a clinical trial title for treating atherosclerosis. It works by inhibiting p38 kinase, an enzyme involved in inflammatory signaling pathways relevant to the diseases under study.

Who makes BMS-582949?

BMS-582949 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of the drug across multiple indications.

What phase is BMS-582949 in?

BMS-582949 has completed Phase 2 clinical trials for psoriasis, rheumatoid arthritis, and vascular diseases. It is an investigational drug and has not been approved by regulatory authorities, as it remains in clinical development.

What clinical trials is BMS-582949 in?

BMS-582949 has been studied in several completed trials. These include NCT00162292, a Phase 1 multiple ascending dose study in rheumatoid arthritis; NCT00399906, a Phase 2 trial in plaque psoriasis; NCT00570752, a Phase 2 study in atherosclerosis; and NCT00605735, a Phase 2 proof-of-concept trial in rheumatoid arthritis.

Is BMS-582949 the same as any other drug?

BMS-582949 is the sole name provided for this investigational compound. No alternative names have been identified in the available information, so it is not known to be the same as any other marketed or investigational drug.