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

Study Identifier
M19-944
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501018-78-00
For general inquiries, please contact
Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Bulgarian, Czech, German (Belgium), German, Spanish, French (Belgium), French, Hungarian, Japanese, Dutch (Belgium), Polish, Slovak, Turkish, Ukrainian

Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
  • Study Drug
  • Upadacitinib
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol 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 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.

    Study Locations

    Location
    Status
    Location
    Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
    Flagstaff, Arizona, United States, 86001-6269
    Status
    Not applicable
    Location
    AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
    Phoenix, Arizona, United States, 85032-9306
    Status
    Not applicable
    Location
    Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
    Tucson, Arizona, United States, 85704
    Status
    Not applicable
    Location
    Newport Huntington Medical Group /ID# 216281
    Huntington Beach, California, United States, 92648-5994
    Status
    Not applicable
    Location
    Inland Rheum & Osteo Med Grp /ID# 215807
    Upland, California, United States, 91786
    Status
    Not applicable
    Location
    Denver Arthritis Clinic /ID# 215346
    Denver, Colorado, United States, 80230
    Status
    Not applicable
    Showing {first} - {last} of {total} Results