A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
← catalyst calendarNCT03398135 · readout ≤ 773 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
1,242actual
Sites
426
Countries
Argentina, Austria, Belgium +40
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2018-08-28 | actual | When the study began enrolling |
| Primary completion | Sep 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Feb 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2018-01-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Ulcerative Colitis (UC)
Interventions
- Drug: risankizumab — also filed as ABBV-066, BI 655066, SKYRIZI
- Drug: placebo for risankizumab
Primary outcomes
what the primary-completion date above is the date OFSub-Study 1: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
measured Week 52
Percentage of Participants with Adverse Events (AE)
measured Up to Week 300
Publications
- PMID 40953785 — linked by the registry
- PMID 40168091 — linked by the registry
- PMID 39804294 — linked by the registry
- PMID 39037800 — linked by the registry
- PMID 38863178 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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