Drugs / Ustekinumab
Ustekinumab Clinical Trials
DrugUstekinumab is marketed as Stelara, a human interleukin-12 and interleukin-23 antagonist used in plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The label includes adult and pediatric indications depending on disease area. U.S. initial approval was in 2009, with indication updates through 2026.
Continuously tracked·last revised
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Recruiting Phase 3
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease NCT06274554 | Phase 3 | Recruiting | Weill Medical College of Cornell University | Started 2024-10 |
| Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients NCT06807593 | Phase 2 | Recruiting | M.D. Anderson Cancer Center | Started 2026-02 |
| Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty NCT07138898 | Phase 2 | Recruiting | NYU Langone Health | Started 2025-12 |
| Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis NCT06453317 | Phase 2 | Recruiting | Medical University of Lodz | Started 2025-02 |
Recently started
Results recently posted
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Unknown | No longer available | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 1 | — | — | — | — | 1 |
| Phase 1 | 1 | — | — | 15 | — | — | — | — | 16 |
| Phase 1/2 | 1 | — | — | 2 | 1 | 1 | 1 | — | 6 |
| Phase 2 | 3 | 1 | 1 | 24 | 1 | 1 | — | — | 31 |
| Phase 2/3 | — | — | 3 | — | — | — | — | — | 3 |
| Phase 3 | 2 | 2 | 5 | 40 | 10 | 1 | 1 | — | 61 |
| Phase 4 | 5 | 2 | — | 6 | 1 | — | 5 | — | 19 |
| Not applicable | 2 | — | — | 1 | — | 1 | 1 | — | 5 |
| Unknown | 9 | 1 | 4 | 20 | — | — | 5 | 1 | 40 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Crohn Disease | — | 2 | 1 | 5 | 1 | 12 | 9 | 3 | 20 | 53 |
| Psoriasis | — | 7 | — | 3 | — | 25 | 7 | — | 7 | 49 |
| Colitis, Ulcerative | — | — | — | 1 | — | 3 | 3 | — | 12 | 19 |
| Arthritis, Psoriatic | — | — | — | 3 | — | 8 | — | — | 5 | 16 |
| Inflammatory Bowel Diseases | — | — | — | 1 | — | 2 | 3 | — | 4 | 10 |
| Skin Diseases | — | — | — | — | — | 4 | — | — | 1 | 5 |
| Arthritis, Rheumatoid | — | — | — | 2 | — | — | — | — | 2 | 4 |
| Dermatitis, Atopic | — | — | — | 2 | — | — | 1 | — | 1 | 4 |
| Lupus Erythematosus, Systemic | — | — | — | 2 | — | 2 | — | — | — | 4 |
| Spondylitis, Ankylosing | — | — | — | 2 | — | 1 | — | — | 1 | 4 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Janssen Research & Development, LLC | 30 | 15 |
| 2 | Centocor, Inc. | 10 | 3 |
| 3 | Janssen Pharmaceutical K.K. | 5 | 3 |
| 4 | AbbVie | 4 | 4 |
| 5 | National Institute of Allergy and Infectious Diseases (NIAID) | 4 | 0 |
| 6 | Bristol-Myers Squibb | 3 | 1 |
| 7 | Janssen-Cilag Ltd. | 3 | 2 |
| 8 | Novartis Pharmaceuticals | 3 | 3 |
| 9 | Second Affiliated Hospital, Zhejiang University, School of Medicine | 3 | 0 |
| 10 | Universitaire Ziekenhuizen KU Leuven | 3 | 1 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Ustekinumab | 182 |
| 2 | Adalimumab | 24 |
| 3 | Infliximab | 20 |
| 4 | guselkumab | 15 |
| 5 | vedolizumab | 14 |
| 6 | Etanercept | 13 |
| 7 | golimumab | 13 |
| 8 | risankizumab | 13 |
| 9 | secukinumab | 11 |
| 10 | Methotrexate | 9 |
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 |
|---|---|---|---|
| NCT04978493 Terminated | Terminated | Company decision | 2024-08-08 |
| NCT04629196 Terminated | Terminated | Other effective drugs have been introduced to market since the beginning of the study. | 2024-01-17 |
| NCT04882072 Terminated | Terminated | Due to difficulties in enrollment and ongoing feasibility issues | 2023-05-25 |
| NCT04305327 Terminated | Terminated | Early terminated due to difficulty recruiting participants | 2023-05-05 |
| NCT03712826 Withdrawn | Withdrawn | No inclusion | 2022-07-24 |
| NCT03981744 Terminated | Terminated | The study did not meet the primary endpoint. | 2022-07-12 |
| NCT03517722 Terminated | Terminated | Study terminated early as a result of the outcome of the pre-planned Interim Analysis | 2020-11-05 |
| NCT02955147 Terminated | Terminated | Inefficacy | 2019-09-19 |
| NCT02437162 Terminated | Terminated | Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies. | 2017-09-06 |
| NCT02438787 Terminated | Terminated | This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies. | 2017-08-31 |
Evidence
- Results reported
- 64.2%70 of 109 completed
- Published
- 1.8%2 of 109 completed
- Primary endpoint met
- 47.8%85 of 178 analyses
- Median months to report
- 13
Documents disclosed
Trial profile
- Median enrollment
- 159
- Median duration
- 32months
- Countries
- 63
- Study sites
- 4695
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 13
- Phase 1
- 91
- Phase 1/2
- 10
- Phase 2
- 102
- Phase 2/3
- 66
- Phase 3
- 386
- Phase 4
- 56
- Not applicable
- 40
- Unknown
- 200
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Warsaw | Poland | 36 |
| 2 | New York | United States | 33 |
| 3 | Berlin | Germany | 32 |
| 4 | Brussels | Belgium | 26 |
| 5 | Budapest | Hungary | 26 |
| 6 | Lodz | Poland | 26 |
| 7 | Tampa | United States | 26 |
| 8 | Houston | United States | 25 |
| 9 | London | United Kingdom | 24 |
| 10 | Hamburg | Germany | 23 |