A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505699-31-00

Acronym

M14-533

Enrollment

167

Registered

2023-12-19

Start date

2017-01-02

Completion date

Unknown

Last updated

2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

Incidence of adverse events (AEs) will be assessed for the Main Study. Changes from the LTE Baseline over time in vital signs, physical examination and clinical laboratory results will also be assessed.

Detailed description

Efficacy endpoint of Main study: Proportion of subjects achieving clinical remission per Adapted Mayo score (defined as SFS ≤ 1 and not greater than baseline, RBS of 0, and end.oscopy subscore ≤ 1) at Week 0, Week 48, and every 48 weeks thereafter.

Interventions

DRUGUpadacitinib

DRUGPlacebo for upadacitinib tablet

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs) will be assessed for the Main Study. Changes from the LTE Baseline over time in vital signs, physical examination and clinical laboratory results will also be assessed.	—

Secondary

Measure	Time frame
Efficacy endpoint of Main study: Proportion of subjects achieving clinical remission per Adapted Mayo score (defined as SFS ≤ 1 and not greater than baseline, RBS of 0, and end.oscopy subscore ≤ 1) at Week 0, Week 48, and every 48 weeks thereafter.	—

Countries

Austria, Belgium, Croatia, Czechia, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026