Clinical trial · Interventional
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)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
NCT01369329CI-TRIAL-00025052completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis | — | UNRESOLVED | — |
| Crohn's Disease | — | UNRESOLVED | — |
| IBD | — | UNRESOLVED | — |
| Inflammatory Bowel Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1: Placebo | Drug | — | UNRESOLVED |
| Group 2 ustekinumab 130 mg | Drug | — | UNRESOLVED |
| Group 3: ustekinumab approximately 6 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- 001
- description
- Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
- interventionNames
- Drug: Group 1: Placebo
- type
- EXPERIMENTAL
- label
- 002
- description
- Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
- interventionNames
- Drug: Group 2 ustekinumab 130 mg
- type
- EXPERIMENTAL
- label
- 003
- description
- Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy * Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of \>= 220 and \<= 450 * Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse) * Or responded initially but then lost response with continued therapy (ie, secondary nonresponse) * Or were intolerant to the medication * Have screening laboratory test results within protocol-specified parameters. Exclusion Criteria: * Patients who have had any kind of bowel resection within 6 months * Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent * Patients who have received infliximab, adalimumab or certolizumab pegol \< = 8 weeks before the first administration of study drug * Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug * Patients with a history of or ongoing chronic or recurrent infectious disease * Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)
References
Publications (15)
- DERIVEDYe BD, Sugimoto K, Cheon JH, Gasink C, Imai Y, Wahking B, Zhuo J, Kawamura S, Hibi T. Efficacy and safety of ustekinumab in Asian patients with moderately to severely active Crohn's disease: a small subpopulation analysis of UNITI/IM-UNITI long-term extension through 5 years. Intest Res. 2026 Jul 10. doi: 10.5217/ir.2025.00285. Online ahead of print. PMID 42427284
- DERIVEDHuan PW, Mehta A, Wong ECL, Dulai PS, Marshall JK, Reinisch W, Narula N. A Review of the Modified Multiplier of Simple Endoscopic Score for Crohn's Disease and How to Use It in Clinical Trials and Practice. Am J Gastroenterol. 2025 Oct 1;120(10):2242-2250. doi: 10.14309/ajg.0000000000003373. Epub 2025 Feb 25. PMID 39996607
- DERIVEDGhosh S, Feagan BG, Ott E, Gasink C, Godwin B, Marano C, Miao Y, Ma T, Loftus EV Jr, Sandborn WJ, Danese S, Abreu MT, Sands BE. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis. J Crohns Colitis. 2024 Aug 6;18(7):1091-1101. doi: 10.1093/ecco-jcc/jjae013. PMID 38310565
- DERIVEDColombel JF, Sands BE, Gasink C, Yeager B, Adedokun OJ, Izanec J, Ma T, Gao LL, Lee SD, Targan SR, Ghosh S, Hanauer SB, Sandborn WJ. Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2024 Jan;22(1):144-153.e2. doi: 10.1016/j.cgh.2023.06.014. Epub 2023 Jun 28. PMID 37391056
- DERIVEDDubinsky M, Ma C, Griffith J, Crowell M, Neimark E, Kligys K, O'Connell T. Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. Adv Ther. 2023 Sep;40(9):3896-3911. doi: 10.1007/s12325-023-02546-6. Epub 2023 Jun 27. PMID 37368103
- DERIVEDAdedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.