A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
← catalyst calendarNCT05995353 · readout ≤ 985 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
110estimated
Sites
85
Countries
Belgium, Bulgaria, Canada +18
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 | 2023-12-11 | actual | When the study began enrolling |
| Primary completion | Apr 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-29 | 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 — also filed as ABBV-066, SKYRIZI
- Drug: Risankizumab — also filed as ABBV-066, SKYRIZI
Primary outcomes
what the primary-completion date above is the date OFCohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
measured At 64 weeks
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
measured At 64 weeks
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
measured Up to approximately Week 64
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
measured Up to approximately 64 weeks
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
measured Up to approximately 64 weeks
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