A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
964actual
Sites
256
Countries
Argentina, Australia, Belgium +36
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 | 2019-03-25 | actual | When the study began enrolling |
| Primary completion | 2020-10-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-09-28 | estimated | The whole study's end, after follow-up |
| First posted | 2018-09-18 | actual | When this record first appeared on the registry |
| Results posted | 2022-02-24 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Psoriatic Arthritis
Interventions
- Biological: Placebo
- Biological: Risankizumab — also filed as ABBV-066, BI 655066, SKYRIZI
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
measured Baseline and Week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2020-09-10 · 11.8 MB · Prot_001.pdf
Statistical Analysis Planposted 2020-11-23 · 886 KB · SAP_002.pdf
Informed Consent Formposted 2020-02-12 · 522 KB · ICF_000.pdf
Publications
- PMID 34911706 — reports results
- PMID 41318485 — linked by the registry
- PMID 41028616 — linked by the registry
- PMID 39120849 — linked by the registry
- PMID 38739215 — linked by the registry
- PMID 38498141 — linked by the registry
- PMID 36282530 — linked by the registry
- PMID 36178584 — linked by the registry
- PMID 35801915 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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