A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

Study Identifier
M16-063
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, Czech, Hungarian, Polish, Spanish

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Elsubrutinib
  • Upadacitinib
  • Placebo for elsubrutinib
  • Placebo for upadacitinib
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.

    Study Locations

    Location
    Status
    Location
    Rheum Assoc of North Alabama /ID# 167382
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    AZ Arthritis & Rheum Research /ID# 167446
    Mesa, Arizona, United States, 85210
    Status
    Not applicable
    Location
    SunValley Arthritis Center, Lt /ID# 213073
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    AZ Arthritis and Rheum Researc /ID# 167448
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    St. Joseph Heritage Healthcare /ID# 167379
    Fullerton, California, United States, 92835
    Status
    Not applicable
    Location
    Purushotham, Akther & Roshan K /ID# 168121
    La Mesa, California, United States, 91942
    Status
    Not applicable
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