Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications
← catalyst calendarNCT04846959 · readout ≤ 2,142 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →. With PPD Development, LP.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
818estimated
Sites
2
Country
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 | 2021-07-30 | actual | When the study began enrolling |
| Primary completion | Jun 2032 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2021-04-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment
Interventions
- Drug: Risankizumab — also filed as Skyrizi
- Drug: Comparator
Primary outcome
what the primary-completion date above is the date OFNumber of Participants with Major Congenital Malformation (MCM)
measured Up to 9 months
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