A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Study Identifier
M16-852
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-505476-29-00
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, Czech, Danish, German (Austria), German (Belgium), German (Switzerland), German, Spanish, French (Belgium), French (Switzerland), French, Hungarian, Italian (Switzerland), Italian, Japanese, Dutch (Belgium), Dutch, Norwegian, Portuguese (Native), Swedish, Greek

Study Details

Medical Condition
  • Giant Cell Arteritis (GCA)
  • Study Drug
  • Upadacitinib
  • Corticosteroid (CS)
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    50+ years

    Protocol Summary

    This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.

    Study Locations

    Location
    Status
    Location
    Rheum Assoc of North Alabama /ID# 168668
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
    Glendale, Arizona, United States, 85306-9802
    Status
    Not applicable
    Location
    VA Long Beach Healthcare System /ID# 203833
    Long Beach, California, United States, 90822-5201
    Status
    Not applicable
    Location
    Robin K. Dore MD, Inc /ID# 201950
    Tustin, California, United States, 92780
    Status
    Not applicable
    Location
    Denver Arthritis Clinic /ID# 171552
    Denver, Colorado, United States, 80230
    Status
    Not applicable
    Location
    Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
    Danbury, Connecticut, United States, 06810-5038
    Status
    Not applicable
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