Phase 3
Completed N=640
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
Source: ClinicalTrials.gov NCT01369342 ↗Enrolled (actual)
640
Serious AEs
5.3%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants With Clinical Response at Week 6 — 60; 108; 116 participants — p=< 0.001
◆ Published Evidence
Established
40citations · ~10 / year
Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.
Summary
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
Linked Publications (5)
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Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.
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Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.
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The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies.
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Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.
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Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Response at Week 6 |
60; 108; 116 | < 0.001 sig |
| SECONDARY Number of Participants in Clinical Remission at Week 8 |
41; 64; 84 | 0.009 sig |
| SECONDARY Number of Participants in Clinical Response at Week 8 |
67; 99; 121 | < 0.001 sig |
| SECONDARY Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6 |
81; 123; 135 | < 0.001 sig |
| SECONDARY Number of Participants With CDAI 70 Point Response at Week 3 |
66; 103; 106 | < 0.001 sig |
Eligibility Criteria
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 Disease Activity Index (CDAI) score of >= 220 and <= 450, with confirmation of active inflammation
- Has failed conventional therapy as demonstrated by having received corticosteroids and/or immunomodulators(ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Have a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses OR Is corticosteroid dependent or has had a history of corticosteroid dependency AND Has not previously demonstrated failure of or intolerance to 1 or more TNF-antagonist therapies (ie, infliximab, adalimumab, or certolizumab pegol) per study criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01369342) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.