Clinical Trials

Multiple clinical trials sponsored by Bristol-Myers Squibb evaluate BMS-986142 in healthy adults and patients with rheumatoid arthritis, general arthritis, and Sjögren's syndrome across Phase I and Phase II protocols. Phase I studies assess safety, dose-ascending pharmacokinetics, metabolic pathways, and drug interactions, while Phase II trials evaluate efficacy and safety. This research portfolio primarily features completed pharmacokinetic studies alongside a terminated Phase II trial.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02638948 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
 2016-02-16 PHASE2
NCT02843659 TERMINATED
Sjögren's Syndrome
Bristol-Myers Squibb
 2016-10-18 PHASE2
NCT02832180 COMPLETED
Arthritis
Bristol-Myers Squibb
 2016-05 PHASE1
NCT02880670 COMPLETED
Arthritis
Bristol-Myers Squibb
 2016-08 PHASE1
NCT02762123 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
 2016-05 PHASE1
NCT02638948 Completed
Rheumatoid Arthritis
Bristol-Myers Squibb
 2016-02-16 Phase 2
NCT02257151 COMPLETED
Healthy Adult
Bristol-Myers Squibb
 2014-09 PHASE1
NCT02456844 COMPLETED
Rheumatoid Arthritis
Bristol-Myers Squibb
 2015-05 PHASE1
NCT02257151 Completed
Healthy Adult
Bristol-Myers Squibb
 2014-09 Phase 1

(data from https://clinicaltrials.gov, updated on 2019-05-28)

Check the BMS-986142 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986142 functions as a potent and reversible inhibitor of Bruton's tyrosine kinase (BTK) that selectively binds the enzyme to block downstream B-cell receptor signaling cascades. This pathway inhibition suppresses B-cell activation and attenuates proinflammatory cytokine release, thereby reducing joint inflammation and tissue destruction associated with autoimmune conditions such as rheumatoid arthritis and Sjögren's syndrome.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.