Drugs / Upadacitinib
Upadacitinib Clinical Trials
DrugMarketed as Rinvoq
Upadacitinib is an oral JAK inhibitor marketed as Rinvoq and indicated across multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, and polyarticular juvenile idiopathic arthritis in specific populations. It carries class boxed warnings for serious infection, malignancy, major cardiovascular events, and thrombosis. Initial U.S. approval was in 2019.
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Recruiting Phase 3
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata NCT07772492 | Phase 3 | Recruiting | AbbVie | Started 2026-08 |
| Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study NCT06928272 | Phase 3 | Recruiting | Douglas D. Fraser | Started 2025-09 |
| A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease NCT06227910 | Phase 3 | Recruiting | Takeda | Started 2025-01 |
| A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis NCT06461897 | Phase 3 | Recruiting | AbbVie | Started 2024-08 |
| Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease NCT06332534 | Phase 3 | Recruiting | AbbVie | Started 2024-08 |
Recently started
Results recently posted
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Unknown | Available | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | 1 | — | — | — | — | — | — | — | 1 |
| Phase 1 | 2 | — | 1 | 3 | — | — | 1 | — | 7 |
| Phase 1/2 | 1 | 1 | — | — | — | — | — | — | 2 |
| Phase 2 | 1 | 5 | 1 | 13 | 1 | — | — | — | 21 |
| Phase 2/3 | — | — | — | 2 | — | — | — | — | 2 |
| Phase 3 | 8 | 1 | 11 | 21 | — | 3 | 1 | — | 45 |
| Phase 4 | 8 | 6 | — | 2 | 1 | — | 2 | — | 19 |
| Not applicable | 3 | — | — | — | — | — | — | — | 3 |
| Unknown | 8 | 2 | 1 | 5 | 1 | — | 3 | 1 | 21 |
Trials started per year
Conditions studied, by phase
| Condition | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis, Rheumatoid | 1 | — | 6 | 1 | 10 | 4 | 1 | 6 | 29 |
| Dermatitis, Atopic | 1 | — | 2 | — | 12 | 3 | — | 6 | 24 |
| Crohn Disease | — | — | 2 | — | 5 | 2 | — | 5 | 14 |
| Colitis, Ulcerative | — | — | — | 1 | 3 | 2 | 1 | 6 | 13 |
| Arthritis | — | — | 3 | — | 8 | — | — | — | 11 |
| Joint Diseases | — | — | 3 | — | 8 | — | — | — | 11 |
| Musculoskeletal Diseases | — | — | 3 | — | 8 | — | — | — | 11 |
| Arthritis, Psoriatic | — | — | 1 | — | 2 | 2 | — | 5 | 10 |
| Axial Spondyloarthritis | — | — | — | — | 1 | 3 | — | 2 | 6 |
| Alopecia Areata | — | — | — | — | 3 | — | — | 2 | 5 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | AbbVie | 61 | 41 |
| 2 | Sixth Affiliated Hospital, Sun Yat-sen University | 9 | 1 |
| 3 | Peking University People's Hospital | 3 | 0 |
| 4 | Berinstein, Jeffrey | 2 | 0 |
| 5 | CARE ARTHRITIS LTD. | 2 | 0 |
| 6 | Second Affiliated Hospital, Zhejiang University, School of Medicine | 2 | 0 |
| 7 | University of California, San Francisco | 2 | 0 |
| 8 | Xijing Hospital of Digestive Diseases | 2 | 0 |
| 9 | AbbVie (prior sponsor, Abbott) | 1 | 0 |
| 10 | Abu Dhabi Stem Cells Center | 1 | 1 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | upadacitinib | 121 |
| 2 | Adalimumab | 12 |
| 3 | baricitinib | 11 |
| 4 | tofacitinib | 11 |
| 5 | dupilumab | 10 |
| 6 | Etanercept | 7 |
| 7 | Adrenal Cortex Hormones | 6 |
| 8 | Methotrexate | 6 |
| 9 | Ustekinumab | 6 |
| 10 | abrocitinib | 5 |
Terminations
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06937788 Terminated | Terminated | Recruitment targets (sample size) could not be met within the planned time frame. | 2026-08-26 |
| NCT06773403 Terminated | Terminated | There was not a big enough patient population to meet recruitment goals | 2025-06-06 |
| NCT04666675 Withdrawn | Withdrawn | Strategic considerations | 2021-03-23 |
| NCT03823378 Terminated | Terminated | Study M16-763 was terminated early as the benefit of each treatment arm from the feeder study (Study M16-063) did not provide appreciable evidence of differentiated clinical effect to warrant further long-term continuation. | 2020-09-09 |
| NCT05379322 Withdrawn | Withdrawn | Decision of the local healthcare authority | — |
| NCT06390722 Withdrawn | Withdrawn | strategic decision | — |
Evidence
- Results reported
- 78.3%36 of 46 completed
- Published
- 8.7%4 of 46 completed
- Primary endpoint met
- 84.7%83 of 98 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 176
- Median duration
- 37.3months
- Countries
- 61
- Study sites
- 9393
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 10
- Phase 1
- 48
- Phase 1/2
- 30
- Phase 2
- 132
- Phase 2/3
- 750
- Phase 3
- 522
- Phase 4
- 110
- Not applicable
- 75
- Unknown
- 117
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Madrid | Spain | 35 |
| 2 | Budapest | Hungary | 32 |
| 3 | London | United Kingdom | 32 |
| 4 | Warsaw | Poland | 31 |
| 5 | Chicago | United States | 30 |
| 6 | Houston | United States | 30 |
| 7 | Seoul | South Korea | 30 |
| 8 | Miami | United States | 29 |
| 9 | San Juan | Puerto Rico | 29 |
| 10 | Tampa | United States | 28 |