Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986142 · 4 trials · 3 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. |
| Group 1: BMS-986142 or placebo | EXPERIMENTAL | BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified |
| Group 2: BMS-986142 or placebo | EXPERIMENTAL | BMS-986142 or placebo Multiple dose oral Solution as specified |
| 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 * ...
Top 20 of 28 competitors
BMS-986142 is an investigational small molecule being studied for the treatment of rheumatoid arthritis and other forms of arthritis. It has been evaluated in clinical trials involving patients with moderate to severe rheumatoid arthritis, as well as in healthy adult volunteers for safety and pharmacokinetic studies.
BMS-986142 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company has sponsored clinical trials of this investigational drug in the United States and multiple other countries.
BMS-986142 has completed Phase 1 and Phase 2 clinical trials. The drug is investigational and has not been approved by regulatory authorities. Its development program includes early-stage safety studies in healthy volunteers and a larger efficacy study in patients with rheumatoid arthritis.
BMS-986142 has been studied in several completed clinical trials, including NCT02257151, a Phase 1 safety and target engagement study in healthy subjects; NCT02638948, a Phase 2 efficacy and safety study in patients with moderate to severe rheumatoid arthritis; and NCT02762123 and NCT02880670, additional Phase 1 pharmacokinetic studies.
BMS-986142 is the investigational code name for this compound developed by Bristol-Myers Squibb. No alternative brand or generic names have been disclosed for this drug in the available clinical trial information.