A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
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Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Na · None · Other
Enrollment
10actual
Sites
3
Countries
Israel, United States
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 | 2024-04-24 | actual | When the study began enrolling |
| Primary completion | 2026-02-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-05 | actual | The whole study's end, after follow-up |
| First posted | 2024-04-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Inflammatory Bowel Disease
Interventions
- Procedure: Breast Milk Sampling
- Drug: Risankizumab — also filed as SKYRIZI
Primary outcomes
what the primary-completion date above is the date OFTo determine the concentration of risankizumab in breastmilk
measured Pre-dose and 1 hour after dosing on Day 1, on Days 4 (± 1), 8 (± 2), 15 (± 3), 29 (± 3), and pre-dose on Day 57 (± 3)
Percentage of Infant Participants With Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)
measured 6 months from Day 1 dose
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