Recent Updates
Recently added Catalysts

BMS-817399

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Trials Updated: Oct 12, 2015

BMS-817399 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2011

BMS-817399 target and mechanism

Molecular targetCCR1
Target classAntagonist
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

BMS-817399 clinical trials

BMS-817399 · 1 trial · 1 indication

Phase 2 1
NCT01404585Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED123 Analytics
PHASE2COMPLETED
Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo
Baseline and at 12 weeks

Secondary Endpoints

Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
16 weeks
Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group
Day 15
Proportion of subjects achieving 20% ACR response in each treatment group
Day 29
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: PlaceboPLACEBO_COMPARATOR -
Arm 2: BMS-817399 (200 mg)EXPERIMENTAL -
Arm 3: BMS-817399 (400 mg)EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGTablets, Oral, 0 mg, twice daily, 12 weeks
BMS-817399DRUGTablets, Oral, 200 mg, twice daily, 12 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects, 18 years of age or older, with rheumatoid arthritis (RA) for at least 6 months prior to screening * Subjects must have a tender joint count of at least 6 (28 joint count), swollen joint count of at least 6 (28 joint count) at screening. All subjects mu...

Countries:United StatesArgentinaMexicoRussiaSouth AfricaSouth KoreaSpain
Unlock Eligibility Criteria

Frequently asked questions about BMS-817399

What is BMS-817399 used for?

BMS-817399 is an investigational small molecule being studied for the treatment of moderate to severe rheumatoid arthritis. It was evaluated in a Phase 2 proof-of-concept study in adults with the condition. It is not an approved therapy and remains in clinical development.

What does BMS-817399 target?

BMS-817399 targets CCR1, a chemokine receptor, and acts as a CCR1 antagonist. By blocking this receptor, the drug is designed to interfere with CCR1-mediated inflammatory signaling, which is relevant to the immune processes involved in rheumatoid arthritis.

Who is developing BMS-817399?

BMS-817399 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 2 proof-of-concept trial of the compound in rheumatoid arthritis.

What phase is BMS-817399 in?

BMS-817399 is in Phase 2 development. One Phase 2 proof-of-concept trial in moderate to severe rheumatoid arthritis has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.

What clinical trials is BMS-817399 in?

BMS-817399 was studied in NCT01404585, a Phase 2 proof-of-concept trial in moderate to severe rheumatoid arthritis. The trial was randomized, double-blind, and placebo-controlled, enrolled 123 participants, and has been completed. It ran in the United States, Argentina, Mexico, Russia, South Africa, South Korea, and Spain.