3 completed. 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 3 |
Follow IBD: new trials by email Literature Review of IBD trials Research Report on IBD
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 |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) Placebo SC, Placebo IV, Ustekinumab 90 mg SC q8w - Crohn's Disease, Colitis | Phase 3 | Completed | Janssen Research & Development, LLC | 1282 | 2011-09-13 | 2025-02-04 |
| A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg, Group 1: Placebo - Crohn's Disease, IBD | Phase 3 | Completed | Janssen Research & Development, LLC | 769 | 2011-07-01 | 2016-12-07 |
| A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) Group 1: Placebo, Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg - Crohn's Disease, Inflammatory Bowel Disease | Phase 3 | Completed | Janssen Research & Development, LLC | 640 | 2011-07-01 | 2017-01-06 |
Colitis (3) · Crohn Disease (3) · Inflammatory Bowel Diseases (3)
Colonic Diseases (3) · Digestive System Diseases (3) · Gastroenteritis (3) · Gastrointestinal Diseases (3) · Intestinal Diseases (3)
Ustekinumab (1)
Janssen Research & Development, LLC (3)
Australia (3) · Belgium (3) · Brazil (3) · Canada (3) · France (3) · Germany (3) · Hungary (3) · Iceland (3) · Israel (3) · Japan (3) · Netherlands (3) · New Zealand (3) · Poland (3) · Serbia (3) · South Africa (3)
PMID 27959607, PMID 29142515, PMID 29409871, PMID 29909019, PMID 30739254, PMID 31279870, PMID 32964215, PMID 34077627, PMID 36150926, PMID 37368103, PMID 37391056, PMID 38310565, PMID 42427284, PMID 29797519, PMID 31158271, PMID 33618023, PMID 35435862, PMID 39996607, PMID 40357993