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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Upadacitinib

Criteria

Inclusion Criteria:

• Study 1: Participant has the clinical diagnosis of ankylosing spondylitis (AS) who meet the modified New York Criteria for AS (Study 1); OR

• Study 2: Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).

• Study 1 and Study 2: Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.

• Study 1: Participants must have had an inadequate response to biologic disease-modifying antirheumatic drug (bDMARD) therapy.

• Study 2: Participant with prior treatment with bDMARD-therapy is allowed.

Exclusion Criteria:

• Participant must not have been exposed to Janus Kinase (JAK) inhibitor.

• Prior bDMARD therapy has to be washed out.

• Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.