A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
107actual
Sites
61
Countries
Belgium, Canada, Czechia +15
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 | 2016-05-18 | actual | When the study began enrolling |
| Primary completion | 2025-07-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-18 | actual | The whole study's end, after follow-up |
| First posted | 2016-05-25 | estimated | When this record first appeared on the registry |
| Results posted | 2026-08-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-13 | 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 (CD)
Intervention
- Drug: ABT-494 — also filed as Upadacitinib, RINVOQ
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants Achieving Endoscopic Remission at Month 12
measured Month 12
Percentage of Participants Achieving Clinical Remission at Month 12
measured Month 12
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-06-29 · 1.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-02-28 · 343 KB · SAP_001.pdf
Publications
- PMID 34968730 — 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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