Clinical Trials

Upadacitinib (ABT-494) is undergoing evaluation in numerous clinical trials across early- to late-phase development for inflammatory and autoimmune disorders, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, alopecia areata, and primary Sjögren's syndrome. Supported by pharmaceutical sponsors such as AbbVie and Takeda alongside academic medical centers like Peking University People's Hospital, these studies encompass pending protocols, active recruitment, and completed evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07772492 RECRUITING
Severe Alopecia Areata
AbbVie
 2026-08-20 PHASE3
NCT06461897 RECRUITING
Atopic Dermatitis
AbbVie
 2024-08-19 PHASE3
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT06012240 RECRUITING
Alopecia Areata
AbbVie
 2023-10-11 PHASE3
NCT07588568 NOT_YET_RECRUITING
EoE; Eosinophilic Esophagitis; Eosinophilic Esophagitis (EoE)
University of North Carolina, Chapel Hill
 2026-10 PHASE2
NCT07258771 RECRUITING
Ulcerative Colitis Acute
Berinstein, Jeffrey
 2026-01-16 PHASE4
NCT07700446 NOT_YET_RECRUITING
Ulcerative Colitis (UC)
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
 2026-11-15 PHASE4
NCT05609630 RECRUITING
Juvenile Idiopathic Arthritis
AbbVie
 2023-10-02 PHASE3
NCT06687551 RECRUITING
Rheumatoid Arthritis (RA
University Hospital, Toulouse
 2025-06-06 PHASE4
NCT07023302 ACTIVE_NOT_RECRUITING
Alopecia Areata
AbbVie
 2025-06-19 PHASE3
NCT07510191 RECRUITING
Crohn Disease (CD)
Sixth Affiliated Hospital, Sun Yat-sen University
 2026-03-01 PHASE4
NCT03725007 ACTIVE_NOT_RECRUITING
Juvenile Idiopathic Arthritis (JIA)
AbbVie
 2019-06-24 PHASE1
NCT07770646 NOT_YET_RECRUITING
Axial Spondyloarthritis (AxSpA)
The University of Texas Health Science Center, Houston
 2026-09-14 PHASE4
NCT06454188 RECRUITING
Psoriatic Arthritis; Spondyloarthritis, Axial
CARE ARTHRITIS LTD.
 2024-12-03 PHASE4
NCT07502339 NOT_YET_RECRUITING
UC - Ulcerative Colitis
University of California, San Francisco
 2026-07-01 PHASE4
NCT05782907 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
AbbVie
 2023-11-06 PHASE3
NCT07670156 NOT_YET_RECRUITING
JAK1 GOF; STAT1 GOF; STAT3 GOF; STAT5B GOF; STAT6 GOF
Lisa Satter
 2026-08 PHASE1; PHASE2
NCT04161898 ACTIVE_NOT_RECRUITING
Takayasu Arteritis (TAK)
AbbVie
 2020-02-04 PHASE3
NCT07550673 RECRUITING
Acute Severe Ulcerative Colitis
Xijing Hospital of Digestive Diseases
 2026-04-20 PHASE4
NCT05889182 ACTIVE_NOT_RECRUITING
Hidradenitis Suppurativa
AbbVie
 2023-06-21 PHASE3
NCT06118411 ACTIVE_NOT_RECRUITING
Vitiligo
AbbVie
 2023-12-19 PHASE3
NCT07492251 NOT_YET_RECRUITING
Lichen Penis Planus
Centre Hospitalier Universitaire de Nice
 2026-06-01 PHASE2
NCT07138898 RECRUITING
Rheumatic Disease
NYU Langone Health
 2025-12-12 PHASE2
NCT07773623 ACTIVE_NOT_RECRUITING
Uveitis
Tianjin Medical University
 2025-01-01 PHASE4
NCT07678645 NOT_YET_RECRUITING
Primary Biliary Cholangitis (PBC); Primary Sclerosing Cholangitis (PSC); Atopic Dermatitis (AD)
RenJi Hospital
 2026-06-01 PHASE2
NCT05867329 RECRUITING
Ulcerative Colitis Acute
Berinstein, Jeffrey
 2023-09-30 PHASE4
NCT03345823 ACTIVE_NOT_RECRUITING
Crohn's Disease
AbbVie
 2018-03-21 PHASE3
NCT07064889 NOT_YET_RECRUITING
Immune Thrombocytopenia
Peking University People's Hospital
 2025-07-30 PHASE2
NCT07727889 ACTIVE_NOT_RECRUITING
Hidradenitis Suppurativa (Acne Inversa)
Peking Union Medical College
 2026-07-01 PHASE2
NCT03006068 ACTIVE_NOT_RECRUITING
Ulcerative Colitis (UC)
AbbVie
 2017-01-31 PHASE3
NCT06227910 RECRUITING
Crohn's Disease
Takeda
 2025-01-02 PHASE3
NCT06684522 RECRUITING
Eyelid Dermatitis
Northwestern University
 2025-12-18 EARLY_PHASE1
NCT06332534 RECRUITING
Crohn's Disease
AbbVie
 2024-08-08 PHASE3
NCT07018206 NOT_YET_RECRUITING
Axial Spondylarthritis (axSpA)
CARE ARTHRITIS LTD.
 2026-05 PHASE4
NCT06660693 RECRUITING
Colitis, Ulcerative
McMaster University
 2025-04-16 PHASE3
NCT07546097 RECRUITING
Acute Severe Ulcerative Colitis
Yongquan Shi
 2026-03-23 PHASE4
NCT07636057 NOT_YET_RECRUITING
Rheumatoid Arthritis (RA)
Sheikh Zayed Federal Postgraduate Medical Institute
 2026-07-05 PHASE4
NCT05843643 ACTIVE_NOT_RECRUITING
Systemic Lupus Erythematosus
AbbVie
 2023-07-25 PHASE3
NCT06701331 ACTIVE_NOT_RECRUITING
Atopic Dermatitis
AbbVie
 2024-12-22 PHASE3
NCT07149467 NOT_YET_RECRUITING
Crohn's Disease Aggravated; Crohn's Disease in Remission
Sixth Affiliated Hospital, Sun Yat-sen University
 2025-09-10 PHASE3
NCT06520397 RECRUITING
Crohn Disease
Sixth Affiliated Hospital, Sun Yat-sen University
 2024-07-15 PHASE4
NCT06862284 NOT_YET_RECRUITING
Primary Sjögren's Syndrome (pSS)
Peking University People's Hospital
 2025-03-10 PHASE2
NCT06928272 RECRUITING
Long COVID
Douglas D. Fraser
 2025-09-10 PHASE3
NCT07008846 ACTIVE_NOT_RECRUITING
Moderate to Severe Rheumatoid Arthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2025-05-10 PHASE3
NCT06873100 RECRUITING
Relapsing Polychondritis
Peking University People's Hospital
 2024-11-15 PHASE1; PHASE2
NCT06389136 RECRUITING
Atopic Dermatitis
AbbVie
 2024-06-14 PHASE3
NCT05814627 COMPLETED
Rheumatoid Arthritis
AbbVie
 2023-06-15 PHASE3
NCT07425899 COMPLETED
Healthy Volunteer
AbbVie
 2026-02-26 PHASE1
NCT06454461 RECRUITING
Vitiligo
Jilin University
 2024-12-04
NCT06390722 WITHDRAWN
Atopic Dermatitis; Sleep Disturbance
AbbVie
 2024-05-23 PHASE3
NCT06902987 RECRUITING
Crohn's Diseases; Active Anal Fistula; Upadacitinib
Sixth Affiliated Hospital, Sun Yat-sen University
 2024-01-17 PHASE1
NCT06095596 RECRUITING
Ulcerative Colitis (UC)
Sixth Affiliated Hospital, Sun Yat-sen University
 2023-11-01
NCT02782663 COMPLETED
Crohn's Disease (CD)
AbbVie
 2016-05-18 PHASE2
NCT06773403 TERMINATED
Prurigo Nodularis
Psoriasis Treatment Center of Central New Jersey
 2024-04-09 PHASE4
NCT07080346 COMPLETED
Behcet Syndrome
Liu Tian
 2024-01-25 PHASE2
NCT06379958 UNKNOWN
Pharmacokinetics
Modern Biosciences Ltd
 2024-04-08 PHASE1
NCT03646604 COMPLETED
Atopic Dermatitis
AbbVie
 2019-01-31 PHASE1
NCT05507580 COMPLETED
Atopic Dermatitis
AbbVie
 2023-05-29 PHASE4
NCT06758947 COMPLETED
Interstitial Lung Disease Due to Systemic Disease (Disorder)
Assiut University
 2023-01-15 PHASE3
NCT05080218 COMPLETED
Rheumatoid Arthritis; Psoriatic Arthritis; Spondylarthritis
Jeffrey Curtis
 2021-11-15 PHASE4
NCT05601882 COMPLETED
Atopic Dermatitis
AbbVie
 2022-11-28 PHASE3
NCT03725202 COMPLETED
Giant Cell Arteritis (GCA)
AbbVie
 2019-01-24 PHASE3
NCT04451772 COMPLETED
Systemic Lupus Erythematosus (SLE)
AbbVie
 2020-07-27 PHASE2
NCT05121298 UNKNOWN
Rheumatoid Arthritis; JAK Inhibitor; Musculoskeletal Ultrasound; Biomarker
Atsushi Kawakami
 2021-01-12 PHASE3
NCT06012240 Recruiting
Alopecia Areata
AbbVie
 2023-10-11 Phase 3
NCT04195698 COMPLETED
Atopic Dermatitis
AbbVie
 2020-01-15 PHASE3
NCT05153200 UNKNOWN
Rheumatoid Arthritis
Ottawa Hospital Research Institute
 2022-01 PHASE4
NCT04927975 COMPLETED
Non-Segmental Vitiligo
AbbVie
 2021-06-30 PHASE2
NCT05496348 Recruiting
Ulcerative Colitis
AbbVie
 2022-10-20 --
NCT03661138 COMPLETED
Atopic Dermatitis
AbbVie
 2018-10-27 PHASE3
NCT05494606 Recruiting
Ulcerative Colitis
AbbVie
 2022-08-15 --
NCT05394792 Recruiting
Atopic Dermatitis
AbbVie
 2022-06-01 --
NCT05327920 Completed
Rheumatoid Arthritis
AbbVie
 2022-04-20 --
NCT05170646 Completed
Rheumatoid Arthritis
AbbVie
 2022-03-14 --
NCT03978520 COMPLETED
Systemic Lupus Erythematosus (SLE)
AbbVie
 2019-07-25 PHASE2
NCT02819635 COMPLETED
Ulcerative Colitis (UC)
AbbVie
 2016-09-26 PHASE2; PHASE3
NCT03345849 COMPLETED
Crohn's Disease
AbbVie
 2017-12-07 PHASE3
NCT04169373 COMPLETED
Spondyloarthritis
AbbVie
 2019-11-26 PHASE3
NCT03345836 COMPLETED
Crohn's Disease
AbbVie
 2017-11-29 PHASE3
NCT02049138 COMPLETED
Rheumatoid Arthritis
AbbVie
 2014-01-24 PHASE2
NCT04430855 COMPLETED
Hidradenitis Suppurativa (HS)
AbbVie
 2020-07-14 PHASE2
NCT04666675 WITHDRAWN
Atopic Dermatitis (AD)
AbbVie
 2020-12-24 PHASE3
NCT03607422 COMPLETED
Atopic Dermatitis
AbbVie
 2018-07-27 PHASE3
NCT03568318 ACTIVE_NOT_RECRUITING
Atopic Dermatitis
AbbVie
 2018-08-09 PHASE3
NCT03653026 COMPLETED
Ulcerative Colitis (UC)
AbbVie
 2018-12-06 PHASE3
NCT03569293 COMPLETED
Atopic Dermatitis
AbbVie
 2018-08-13 PHASE3
NCT03823378 TERMINATED
Rheumatoid Arthritis (RA)
AbbVie
 2019-05-13 PHASE2
NCT03738397 COMPLETED
Atopic Dermatitis
AbbVie
 2019-02-21 PHASE3
NCT03682705 COMPLETED
Rheumatoid Arthritis (RA)
AbbVie
 2018-10-08 PHASE2
NCT03104400 COMPLETED
Psoriatic Arthritis
AbbVie
 2017-04-27 PHASE3
NCT02955212 COMPLETED
Rheumatoid Arthritis (RA)
AbbVie
 2018-01-03 PHASE3
NCT03104374 COMPLETED
Psoriatic Arthritis
AbbVie
 2017-05-01 PHASE3
NCT03086343 COMPLETED
Rheumatoid Arthritis (RA)
AbbVie
 2017-05-09 PHASE3
NCT03178487 COMPLETED
Ankylosing Spondylitis (AS)
AbbVie
 2017-10-24 PHASE2
NCT02706873 COMPLETED
Rheumatoid Arthritis
AbbVie
 2016-02-23 PHASE3
NCT02629159 ACTIVE_NOT_RECRUITING
Rheumatoid Arthritis
AbbVie
 2015-12-01 PHASE3
NCT02706951 COMPLETED
Rheumatoid Arthritis
AbbVie
 2016-03-23 PHASE3
NCT02925117 COMPLETED
Atopic Dermatitis
AbbVie
 2016-10-25 PHASE2
NCT02720523 COMPLETED
Rheumatoid Arthritis
AbbVie
 2016-03-22 PHASE2; PHASE3
NCT02675426 COMPLETED
Rheumatoid Arthritis
AbbVie
 2015-12-17 PHASE3
NCT02706847 COMPLETED
Rheumatoid Arthritis
AbbVie
 2016-03-15 PHASE3
NCT02365649 COMPLETED
Crohn's Disease
AbbVie
 2015-03-17 PHASE2
NCT02066389 COMPLETED
Rheumatoid Arthritis
AbbVie
 2014-03-26 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the ABT-494 (Upadacitinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Upadacitinib acts as a selective Janus kinase 1 (JAK1) inhibitor that binds the JAK1 enzyme, thereby blocking downstream signal transducer and activator of transcription (STAT) phosphorylation and preventing the intracellular signal transduction of pro-inflammatory cytokines. This inhibition suppresses pathogenic immune cell activation and cytokine-driven inflammatory cascades, providing a mechanistic basis for its therapeutic efficacy in clinical trial conditions such as rheumatoid arthritis, atopic dermatitis, and ulcerative colitis.

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.