A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
← catalyst calendarNCT07071519 · readout ≤ 2,903 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
120estimated
Sites
55
Countries
Belgium, Brazil, Canada +12
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 | 2025-07-28 | actual | When the study began enrolling |
| Primary completion | Jul 2034 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2034 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | 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
Interventions
- Drug: Risankizumab — also filed as ABBV-066
- Drug: Risankizumab — also filed as ABBV-066
Primary outcomes
what the primary-completion date above is the date OFPK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
measured At Week 64
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
measured At Week 64
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
measured At Week 64
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
measured At Week 64
PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
measured At Week 64
PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
measured At Week 64
Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS
measured At Week 64
Number of Participants With Adverse Events
measured Up to 292 Weeks
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