A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
← catalyst calendarNCT03345823 · readout ≤ 407 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
747estimated
Sites
466
Countries
Argentina, Australia, Austria +46
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 | 2018-03-21 | actual | When the study began enrolling |
| Primary completion | Sep 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2017-11-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | 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: Upadacitinib — also filed as ABT-494, RINVOQ
- Drug: Placebo for Upadacitinib
Primary outcomes
what the primary-completion date above is the date OFSub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
measured Week 52
Sub-Study 1: Percentage of Participants with Endoscopic Response
measured Week 52
Number of Participants with Adverse Events
measured Through Week 240
Publications
- PMID 41763462 — linked by the registry
- PMID 41264726 — linked by the registry
- PMID 41189093 — linked by the registry
- PMID 40875187 — linked by the registry
- PMID 40738276 — linked by the registry
- PMID 40704669 — linked by the registry
- PMID 39326583 — linked by the registry
- PMID 39231444 — linked by the registry
- PMID 38982567 — linked by the registry
- PMID 38835235 — linked by the registry
- PMID 38492904 — linked by the registry
- PMID 38492903 — linked by the registry
- PMID 37224198 — 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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