Overview

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis

Status:
Active, not recruiting

Trial end date:
2025-07-03

Target enrollment:

Participant gender:

Summary

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: - To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). - To assess the safety and tolerability of upadacitinib in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2). - To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and with nr-axSpA who have completed the Double-Blind Period (Study 2). - To evaluate the maintenance of disease control after withdrawal of upadacitinib.

Phase:

Phase 3

Details

Lead Sponsor:

AbbVie

Treatments:

Upadacitinib