A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
← catalyst calendarNCT06063967 · readout ≤ 224 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
289actual
Sites
179
Countries
Argentina, Brazil, Canada +17
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 | 2023-11-15 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-09-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Crohn's Disease
Interventions
- Drug: Risankizumab SC — also filed as ABBV-066, SKYRIZI
- Drug: Placebo for risankizumab
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)
measured Week 12
Percentage of Participants With Endoscopic Response
measured Week 12
Number of Participants Experiencing Adverse Events
measured Up to approximately 96 weeks
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