5 completed, 2 terminated, 1 recruiting. 6 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Terminated 2 |
| Phase 2 | 1 | Completed 1 |
Follow Ustekinumab 45 mg: new trials by email Literature Review of Ustekinumab 45 mg trials Research Report on Ustekinumab 45 mg
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar Ustekinumab 45 mg, Ustekinumab 90 mg - Crohn Disease, Plaque Psoriasis | Recruiting | Celltrion HealthCare France | 225 | 2025-03-17 | 2025-05-30 | |
| An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg - Psoriasis | Phase 3 | Completed | Janssen Research & Development, LLC | 44 | 2016-05-01 | 2021-11-01 |
| A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg - Axial Spondyloarthritis | Phase 3 | Terminated | Janssen Research & Development, LLC | 347 | 2015-09-03 | 2025-04-29 |
| A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg - Axial Spondyloarthritis | Phase 3 | Terminated | Janssen Research & Development, LLC | 315 | 2015-07-31 | 2025-04-29 |
| A Study of Ustekinumab to Evaluate a "Subject-tailored" Maintenance Dosing Approach in Subjects With Moderate-to-Severe Plaque Psoriasis Ustekinumab 45 mg, Ustekinumab 90 mg, Placebo - Psoriasis | Phase 3 | Completed | Janssen Biotech, Inc. | 478 | 2012-03-01 | 2017-02-09 |
| A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg - Primary Biliary Cirrhosis | Phase 2 | Completed | Janssen Research & Development, LLC | 20 | 2011-09-01 | 2016-06-20 |
| A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents placebo, ustekinumab 45 mg, ustekinumab 90 mg - Arthritis, Psoriatic | Phase 3 | Completed | Janssen Research & Development, LLC | 312 | 2010-03-01 | 2014-02-27 |
| A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis Placebo, Ustekinumab 45 mg, Ustekinumab 90 mg - Arthritis, Psoriatic | Phase 3 | Completed | Janssen Research & Development, LLC | 615 | 2009-12-01 | 2015-03-03 |
Psoriasis (4) · Arthritis, Psoriatic (2) · Axial Spondyloarthritis (2) · Crohn Disease (1) · Liver Cirrhosis, Biliary (1) · Skin Diseases (1) · Spondylitis, Ankylosing (1)
Janssen Research & Development, LLC (6) · Celltrion HealthCare France (1) · Janssen Biotech, Inc. (1)
United States (7) · Canada (5) · Poland (5) · Germany (4) · Hungary (4) · Russia (4) · France (3) · South Korea (3) · Taiwan (3) · United Kingdom (3) · Austria (2) · Belgium (2) · Czechia (2) · Spain (2) · Ukraine (2)
PMID 27098404, PMID 27483458, PMID 30225992, PMID 30739254, PMID 31070869, PMID 32209721, PMID 36995469, PMID 39120848, PMID 23769296, PMID 25543678, PMID 26097039, PMID 28600818, PMID 29559344, PMID 36171515
2009 (2), 2014 (1), 2015 (1), 2016 (1)