Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Branebrutinib
BMS-986195 · 5 trials · 4 indications
mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index
Composite response is defined as the percent of participants with at least 3 of the following at Week 24: * Decrease of ≥ 1 point or 15% from baseline in the ESSPRI Total Score * Decrease of ≥ 3 points from baseline in ESSDAI score * Decrease of ≥ 25% from baseline in ocular staining score, or if normal score at baseline no change to abnormal * Increase of ≥ 25% from baseline in stimulated salivary flow * Improvement in one or more serological markers (rheumatoid factor (RF), immunoglobulin G protein (IgG), complement C3 or C4, cryoglobulin).
ACR50 response is defined as both improvement of 50% in the number of tender and swollen joints and a 50% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.
Measured by plasma concentrations
Measured by plasma concentrations
| Arm | Type | Description |
|---|---|---|
| Systemic Lupus Erythematosus (SLE): branebrutinib | EXPERIMENTAL | - |
| SLE: placebo | PLACEBO_COMPARATOR | - |
| Primary Sjögren's Syndrome (pSS): branebrutinib | EXPERIMENTAL | - |
| pSS: placebo | PLACEBO_COMPARATOR | - |
| Rheumatoid Arthritis (RA): branebrutinib followed by abatacept | EXPERIMENTAL | - |
| RA: placebo followed by abatacept | PLACEBO_COMPARATOR | - |
| BMS-986195 and Oral Contraceptive | EXPERIMENTAL | Oral administration of contraceptive, then progress to combination |
| BMS-986195 | EXPERIMENTAL | A single oral solution dose of BMS-986195 |
| Methotrexate | EXPERIMENTAL | Methotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days |
| Cytochrome P450 and Transporter Substrates | EXPERIMENTAL | Caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days. |
| Single Ascending Dose (SAD) | PLACEBO_COMPARATOR | Single ascending dose of BMS-986195 or Placebo matching BMS-986195 |
| Multiple Ascending Dose(MAD) | PLACEBO_COMPARATOR | Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 |
| Japanese-Multiple Ascending Dose(MAD) | PLACEBO_COMPARATOR | Multiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage |
| Relative Bioavailability with Food Effects (Open Label) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| branebrutinib | DRUG | Specified dose on specified days |
| abatacept | DRUG | Specified dose on specified days |
| branebrutinib placebo | DRUG | Specified dose on specified days |
| BMS-986195 | DRUG | Oral administration of specified dose on specified days |
| Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol) | DRUG | Oral Contraceptive |
| Methotrexate | DRUG | Specified dose on specified days |
| Leucovorin | DRUG | Specified dose on specified days |
| Caffeine | DRUG | Specified dose on specified days |
| Montelukast | DRUG | Specified dose on specified days |
| Flurbiprofen | DRUG | Specified dose on specified days |
| Omeprazole | DRUG | Specified dose on specified days |
| Midazolam | DRUG | Specified dose on specified days |
| Digoxin | DRUG | Specified dose on specified days |
| Pravastatin | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified day |
Inclusion Criteria: Sub-study for Systemic Lupus Erythematosus (SLE) * Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification * Diagnosed with SLE more than 24 weeks before screening visit Sub-study for primary Sjögren's Syndrome (pSS)...
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BMS-986195 is an investigational small molecule being developed for rheumatoid arthritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, and interactions with other medications.
BMS-986195 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects.
BMS-986195 is in Phase 1 clinical development. All four clinical trials for this drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval for any indication.
BMS-986195 has completed four Phase 1 clinical trials: NCT02705989, a safety and bioavailability study in healthy subjects; NCT03131973, a drug interaction study with methotrexate and other medications; NCT03245515, a study in healthy male subjects; and NCT03262740, a study with an oral contraceptive in healthy female subjects.
No alternative names for BMS-986195 have been identified. The drug is referred to solely by its development code BMS-986195 in clinical trial registries and available information.