Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986142 · 3 trials · 2 indications
ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)\*100
ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)\*100
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo + Methotrexate dose as specified |
| Dose Level 1 | EXPERIMENTAL | BMS-986142 at dose level 1+ Methotrexate as specified |
| Dose Level 2 | EXPERIMENTAL | BMS-986142 at dose level 2 + Methotrexate as specified |
| Single dose of radiolabeled BMS-986142 | EXPERIMENTAL | - |
| Cohort 1 (BMS-986142: 200 mg) | EXPERIMENTAL | 200mg BMS-986142 administered orally once daily on specified days. |
| Cohort 2 (BMS-986142: 350 mg) | EXPERIMENTAL | 350mg BMS-986142 administered orally once daily on specified days. |
| Name | Type | Description |
|---|---|---|
| BMS-986142 | DRUG | BMS986142 specific dose on specific days |
| Placebo | DRUG | Placebo of BMS-986142 specific dose on specific days |
| Methotrexate | DRUG | Methotrexate specific dose on specific days |
| BMS-986142 200mg | DRUG | - |
| BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin) | DRUG | - |
| BMS-986142 350mg | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male and female age 18 and above * Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III * ...
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BMS-986142 is an investigational small molecule being studied for the treatment of arthritis, including rheumatoid arthritis. It has been evaluated in clinical trials in patients with moderate to severe rheumatoid arthritis. It is not approved for any indication and remains in clinical development.
BMS-986142 targets Bruton's tyrosine kinase (BTK). It is a BTK inhibitor. BTK is an enzyme involved in B cell receptor signaling, and inhibiting it is the intended mechanism of action for this investigational small molecule in inflammatory joint disease.
BMS-986142 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsors the clinical trials evaluating the drug in arthritis and rheumatoid arthritis.
BMS-986142 is in Phase 1 development according to its listed development stage, though a Phase 2 efficacy and safety study in rheumatoid arthritis has also been completed. It is an investigational drug and has not been approved by the FDA for any indication.
BMS-986142 has been studied in completed trials including NCT02880670, a pharmacokinetics and metabolism study in healthy male subjects, NCT02762123, a drug interaction study with probe substrates, and NCT02638948, a Phase 2 efficacy and safety study in moderate to severe rheumatoid arthritis.