Clinical Trials

Numerous clinical trials ranging from Early Phase 1 to Phase 4 evaluate deucravacitinib (BMS-986165) across completed, recruiting, and active non-recruiting statuses. Investigations primarily focus on autoimmune and inflammatory conditions—such as plaque psoriasis, psoriatic arthritis, subacute cutaneous and discoid lupus erythematosus, and systemic lupus erythematosus—alongside pharmacokinetic assessments in healthy participants. These initiatives are sponsored by pharmaceutical companies including Bristol-Myers Squibb and Takeda, in collaboration with academic centers such as the University of California, San Francisco and Peking University First Hospital.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07116967 RECRUITING
Plaque Psoriasis
Bristol-Myers Squibb
 2025-09-22 PHASE3
NCT07791199 NOT_YET_RECRUITING
Systemic Lupus Erythematosus; Sjögren's Disease; Psoriasis; Psoriatic Arthritis
Bristol-Myers Squibb
 2026-12-31 PHASE3
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT06869551 RECRUITING
Juvenile Psoriatic Arthritis
Bristol-Myers Squibb
 2025-03-13 PHASE3
NCT07335796 RECRUITING
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2026-01-09 PHASE2
NCT06979453 RECRUITING
Plaque Psoriasis
Bristol-Myers Squibb
 2025-12-03 PHASE3
NCT04772079 RECRUITING
Plaque Psoriasis
Bristol-Myers Squibb
 2021-03-23 PHASE3
NCT07508488 RECRUITING
Central Centrifugal Cicatricial Alopecia; Frontal Fibrosing Alopecia
Icahn School of Medicine at Mount Sinai
 2026-05-28 PHASE2
NCT05858645 RECRUITING
Psoriasis Vulgaris
University of California, San Francisco
 2023-10-01 PHASE4
NCT07013838 NOT_YET_RECRUITING
Takayasu Arteritis (TAK)
Chinese SLE Treatment And Research Group
 2025-06-15 PHASE4
NCT07280702 RECRUITING
Psoriatic Arthritis (PsA)
University of Texas Southwestern Medical Center
 2026-06-16 PHASE4
NCT07724366 NOT_YET_RECRUITING
Psoriasis
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
 2026-08 PHASE3
NCT07326813 RECRUITING
Plaque Psoriasis
InventisBio Co., Ltd
 2026-01-12 PHASE3
NCT06875960 RECRUITING
Systemic Lupus Erythematosus (SLE); Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Bristol-Myers Squibb
 2026-02-24 PHASE4
NCT05946941 ACTIVE_NOT_RECRUITING
Sjögren's Syndrome
Bristol-Myers Squibb
 2023-09-11 PHASE3
NCT06327321 ACTIVE_NOT_RECRUITING
Vitiligo, Generalized
Centre Hospitalier Universitaire de Nice
 2024-05-05 PHASE2
NCT05570955 ACTIVE_NOT_RECRUITING
Psoriasis
Wake Forest University Health Sciences
 2023-07-24
NCT05617677 ACTIVE_NOT_RECRUITING
Systemic Lupus Erythematosus
Bristol-Myers Squibb
 2023-01-12 PHASE3
NCT05620407 ACTIVE_NOT_RECRUITING
Systemic Lupus Erythematosus
Bristol-Myers Squibb
 2023-01-12 PHASE3
NCT04036435 ACTIVE_NOT_RECRUITING
Psoriasis
Bristol-Myers Squibb
 2019-08-12 PHASE3
NCT06725264 WITHDRAWN
Sarcoidosis; Granuloma Annulare
Yale University
 2025-03 PHASE2
NCT06973291 COMPLETED
Plaque Psoriasis
Takeda
 2025-07-09 PHASE3
NCT06333860 COMPLETED
Moderate Plaque Psoriasis
AbbVie
 2024-05-10 PHASE4
NCT06532136 WITHDRAWN
Papulopustular Rosacea
Icahn School of Medicine at Mount Sinai
 2024-11 PHASE2
NCT05124080 COMPLETED
Nail Psoriasis
University of Alabama at Birmingham
 2024-03-01 EARLY_PHASE1
NCT07000630 TERMINATED
Palmoplantar Pustulosis
Peking University First Hospital
 2025-06-20
NCT07012057 WITHDRAWN
Myositis; Dermatomyositis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 2025-11-21 PHASE2
NCT06136403 RECRUITING
Epidermolysis Bullosa Simplex; Ichthyosis; Genodermatosis; Inflammatory Congenital Ichthyoses
Centre Hospitalier Universitaire de Nice
 2024-03-18 PHASE2
NCT06444399 COMPLETED
Pityriasis Rubra Pilaris
Mayo Clinic
 2024-07-29 PHASE2
NCT06566768 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2024-10-07 PHASE1
NCT06042920 TERMINATED
Palmoplantar Psoriasis; Genital Psoriasis
Bristol-Myers Squibb
 2023-10-09 PHASE4
NCT06851871 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2025-01-23 PHASE1
NCT03920267 COMPLETED
Systemic Lupus Erythematosus
Bristol-Myers Squibb
 2019-03-26 PHASE2
NCT06281106 TERMINATED
Psoriasis
Prof Curdin Conrad
 2024-06-20 PHASE2; PHASE3
NCT05997277 TERMINATED
Hidradenitis Suppurativa
Beth Israel Deaconess Medical Center
 2023-11-30 PHASE2
NCT05710185 TERMINATED
Palmoplantar Pustulosis
Brigham and Women's Hospital
 2023-07-01 PHASE4
NCT06220604 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2024-03-09 PHASE3
NCT06476834 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2024-06-24 PHASE4
NCT06143878 ACTIVE_NOT_RECRUITING
Plaque Psoriasis
Janssen Research & Development, LLC
 2024-02-01 PHASE3
NCT04908202 ACTIVE_NOT_RECRUITING
Psoriatic Arthritis
Bristol-Myers Squibb
 2021-07-13 PHASE3
NCT05701995 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2023-01-31 PHASE4
NCT04857034 ACTIVE_NOT_RECRUITING
Lupus Erythematosus, Discoid; Lupus Erythematosus, Subacute Cutaneous
Bristol-Myers Squibb
 2021-07-12 PHASE2
NCT06091956 COMPLETED
Lichen Planopilaris
Mayo Clinic
 2023-11-07 PHASE2
NCT05821374 WITHDRAWN
Pyoderma Gangrenosum
Dartmouth-Hitchcock Medical Center
 2024-04-29 EARLY_PHASE1
NCT04908189 ACTIVE_NOT_RECRUITING
Psoriatic Arthritis
Bristol-Myers Squibb
 2021-07-15 PHASE3
NCT05478499 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2022-10-06 PHASE4
NCT05556265 TERMINATED
Alopecia Areata
Bristol-Myers Squibb
 2022-11-08 PHASE2
NCT06329258 COMPLETED
Psoriasis
Psoriasis Treatment Center of Central New Jersey
 2022-12-06 PHASE4
NCT04877990 COMPLETED
Crohn Disease; Ulcerative Colitis
Bristol-Myers Squibb
 2021-05-07 PHASE2
NCT04613518 COMPLETED
Colitis, Ulcerative
Bristol-Myers Squibb
 2021-03-15 PHASE2
NCT03599622 TERMINATED
Granulomatous Colitis; Crohn's Disease; Crohn's Enteritis; Granulomatous Enteritis
Bristol-Myers Squibb
 2018-07-16 PHASE2
NCT04949269 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2021-07-20 PHASE1
NCT03252587 COMPLETED
Systemic Lupus Erythematosus
Bristol-Myers Squibb
 2017-09-21 PHASE2
NCT03934216 COMPLETED
Ulcerative Colitis
Bristol-Myers Squibb
 2019-07-01 PHASE2
NCT03924427 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2019-04-10 PHASE3
NCT04167462 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2019-11-25 PHASE3
NCT04671953 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-12-18 PHASE1
NCT04536961 COMPLETED
Healthy Volunteers
Bristol-Myers Squibb
 2020-09-10 PHASE1
NCT04671953 Completed
Healthy Participants
Bristol-Myers Squibb
 2020-12-18 Phase 1
NCT03611751 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2018-07-26 PHASE3
NCT04305899 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-08-31 PHASE1
NCT03943147 TERMINATED
Lupus Nephritis
Bristol-Myers Squibb
 2019-07-15 PHASE2
NCT03624127 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2018-08-07 PHASE3
NCT03881059 COMPLETED
Active Psoriatic Arthritis
Bristol-Myers Squibb
 2019-04-01 PHASE2
NCT04249284 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-02-06 PHASE1
NCT03890770 COMPLETED
Renal Impairment; Healthy Volunteer
Bristol-Myers Squibb
 2019-04-04 PHASE1
NCT04209699 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2019-12-27 PHASE1
NCT04065932 COMPLETED
Lupus
Bristol-Myers Squibb
 2019-08-22 PHASE1
NCT04209699 Completed
Healthy Participants
Bristol-Myers Squibb
 2019-12-27 Phase 1
NCT03890809 COMPLETED
Liver Dysfunction; Healthy Volunteers
Bristol-Myers Squibb
 2019-02-26 PHASE1
NCT04113668 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2019-10-01 PHASE1
NCT04086719 COMPLETED
Healthy Male Volunteers
Bristol-Myers Squibb
 2019-09-12 PHASE1
NCT04113668 Completed
Healthy Participants
Bristol-Myers Squibb
 2019-10-01 Phase 1
NCT03956953 COMPLETED
Autoimmune Diseases
Bristol-Myers Squibb
 2019-04-04 PHASE1
NCT04055506 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2019-08-14 PHASE1
NCT03979248 COMPLETED
Healthy
Bristol-Myers Squibb
 2019-05-16 PHASE1
NCT03930602 COMPLETED
Healthy
Bristol-Myers Squibb
 2019-05-01 PHASE1
NCT03873415 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2019-01-25 PHASE1
NCT03739788 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-12-05 PHASE1
NCT03751228 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-10-11 PHASE1
NCT03660436 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2018-08-14 PHASE1
NCT03541564 COMPLETED
Systemic Lupus Erythematosus; Healthy Participants
Bristol-Myers Squibb
 2018-05-30 PHASE1
NCT03419910 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2018-03-05 PHASE1
NCT03402087 COMPLETED
Lupus; Psoriatic Arthritis
Bristol-Myers Squibb
 2018-01-08 PHASE1
NCT03262727 COMPLETED
Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis; Inflammatory Bowel Diseases
Bristol-Myers Squibb
 2017-09-01 PHASE1
NCT02931838 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2016-11-15 PHASE2
NCT03254784 COMPLETED
Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis; Inflammatory Bowel Diseases
Bristol-Myers Squibb
 2017-09-13 PHASE1
NCT03044873 COMPLETED
Autoimmune Diseases; Inflammatory Diseases
Bristol-Myers Squibb
 2017-02-02 PHASE1
NCT03004768 COMPLETED
Psoriasis
Bristol-Myers Squibb
 2017-01-26 PHASE1
NCT02534636 COMPLETED
Healthy Subjects
Bristol-Myers Squibb
 2015-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the BMS-986165 (Deucravacitinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deucravacitinib (BMS-986165) selectively binds to the regulatory pseudokinase domain of tyrosine kinase 2 (Tyk2) with high affinity, locking the enzyme in an inactive conformation and preventing receptor-mediated downstream signaling pathways. By suppressing downstream STAT activation and subsequent proinflammatory cytokine production, this allosteric inhibition attenuates immune-mediated inflammatory cascades, providing therapeutic efficacy in clinical conditions such as plaque psoriasis and systemic lupus erythematosus.

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.