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

Completed · Phase 3 · Has a placebo group

Conditions studied: Spondyloarthritis

In brief

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 adults 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 adults with active axSpA including bDMARD-IR AS (Study 1) and 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 nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib.

Key facts

Study ID

NCT04169373

Run by

AbbVie

People needed

734

Starts

2019-11-26

Expected to finish

2025-02-28

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study 1:
• Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS,
• Must not have total spinal ankylosis
• Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must have discontinued the bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to two bDMARDs was allowed for no more than 30% of patients; among patients with prior exposure to two bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was permitted, but a patient could not have a lack of efficacy to two bDMARDs
• Study 2:
• Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS
• Must have objective signs of active inflammation consistent with axSpA on magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high sensitivity C-reactive protein (hsCRP) > the upper limit of normal (ULN).
• Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is allowed for at least 20% but no more than 35% of enrolled patients who had to discontinue the prior bDMARD due to either lack of efficacy (after ≥ 12 weeks at an adequate dose) or intolerance (regardless of treatment duration).
• Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits.
• Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.
• Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.

You may not qualify if…

• Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], baricitinib [Olumiant®], filgotinib, ruxolitinib [Jakafi®], abrocitinib [PF-04965842], and peficitinib [Smyraf®]).
• Prior bDMARD therapy must be washed out.
• Participant must not have a history of an allergic reaction or significant sensitivity to constituents of the study drug.

Where it is running

• AZ Arthritis and Rheumotology Research, PLLC /ID# 215113 — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731 — Tucson, Arizona, United States
• Newport Huntington Medical Group /ID# 216281 — Huntington Beach, California, United States
• Inland Rheum & Osteo Med Grp /ID# 215807 — Upland, California, United States
• Denver Arthritis Clinic /ID# 215346 — Denver, Colorado, United States
• Tekton Research /ID# 215054 — Fort Collins, Colorado, United States
• Arthritis & Rheumatic Disease Specialties /ID# 215306 — Aventura, Florida, United States
• Sweet Hope Research Specialty Inc /ID# 215931 — Hialeah, Florida, United States
• Innovation Medical Research Center /ID# 216068 — Palmetto Bay, Florida, United States
• Conquest Research /ID# 215804 — Winter Park, Florida, United States
• Great Lakes Clinical Trials /ID# 215790 — Chicago, Illinois, United States
• Greater Chicago Specialty Physicians /ID# 216213 — Schaumburg, Illinois, United States
• Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055 — Skokie, Illinois, United States
• Klein and Associates MD /ID# 214767 — Hagerstown, Maryland, United States
• Tufts Medical Center /ID# 215925 — Boston, Massachusetts, United States
• Clinical Pharmacology Study Group /ID# 215293 — Worcester, Massachusetts, United States
• Wayne State University Health Center /ID# 215930 — Detroit, Michigan, United States
• Advanced Rheumatology, PC /ID# 214973 — Lansing, Michigan, United States
• St. Paul Rheumatology /ID# 215537 — Eagan, Minnesota, United States
• Clinvest Research LLC /ID# 215785 — Springfield, Missouri, United States
• CenterPointe Institute of Research /ID# 215793 — St Louis, Missouri, United States
• NYU Langone Orthopedic Center /ID# 215594 — New York, New York, United States
• St. Lawrence Health System /ID# 215844 — Potsdam, New York, United States
• Cape Fear Arthritis Care /ID# 215927 — Leland, North Carolina, United States
• Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282 — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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