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

Completed · Phase 3 · Has a placebo group

Conditions studied: Giant Cell Arteritis (GCA)

In brief

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.

Key facts

Study ID

NCT03725202

Run by

AbbVie

People needed

429

Starts

2019-01-24

Expected to finish

2025-03-11

Last updated by the study team

2026-02-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of giant cell arteritis (GCA) according to the following criteria:
• History of erythrocyte sedimentation rate (ESR) >= 50 mm/hour or high sensitivity C-reactive protein (hsCRP)/CRP >=1.0 mg/dL
• Presence of at least one of the following: Unequivocal cranial symptoms of GCA or Unequivocal symptoms of polymyalgia rheumatica (PMR)
• Presence of at least one of the following: temporal artery biopsy revealing features of GCA or evidence of large vessel vasculitis by angiography or cross-sectional imaging such as ultrasound, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET).
• Active GCA, either new onset or relapsing, within 8 weeks of Baseline.
• Participants must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily (QD) at Baseline.
• Participants must have GCA that, in the opinion of the investigator, is clinically stable to allow the participant to safely initiate the protocol-defined corticosteroid (CS) taper regimen.
• Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.

You may not qualify if…

• Prior exposure to any Janus Kinase (JAK) inhibitor.
• Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
• Use of any of the following systemic immunosuppressant treatments within the specified timeframe prior to study start:
• Anakinra within 1 week of study start.
• Methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate within 4 weeks of study start.
• Oral corticosteroid (CS) for conditions other than GCA within 4 week of study start, or intravenous CS within 4 weeks of study start.
• Greater than or equal to 8 weeks for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.
• Cell-depleting agents or alkylating agents including cyclophosphamide within 6 months of study start.
• Current or past history of infection including herpes zoster or herpes simplex, human immunodeficiency virus (HIV), active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
• Female who is pregnant, breastfeeding, or considering pregnancy during the study.

Where it is running

• Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702 — Glendale, Arizona, United States
• VA Long Beach Healthcare System /ID# 203833 — Long Beach, California, United States
• Robin K. Dore MD, Inc /ID# 201950 — Tustin, California, United States
• Denver Arthritis Clinic /ID# 171552 — Denver, Colorado, United States
• Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071 — Danbury, Connecticut, United States
• Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 169040 — Boca Raton, Florida, United States
• Lakes Research, LLC /ID# 210442 — Miami, Florida, United States
• Ctr Arthritis & Rheumatic Dise /ID# 168667 — Miami, Florida, United States
• Medallion Clinical Research Institute, LLC /ID# 168666 — Naples, Florida, United States
• Omega Research Group /ID# 201903 — Orlando, Florida, United States
• IRIS Research and Development, LLC /ID# 169406 — Plantation, Florida, United States
• Clinical Research of West Florida - Tampa /ID# 201899 — Tampa, Florida, United States
• Clinical Research of West Florida, Inc /ID# 201901 — Tampa, Florida, United States
• Duplicate_University of South Florida /ID# 207077 — Tampa, Florida, United States
• Lovelace Scientific Resources /ID# 169041 — Venice, Florida, United States
• Arthritis and Rheumatology /ID# 170295 — Atlanta, Georgia, United States
• Institute of Arthritis Research /ID# 168490 — Idaho Falls, Idaho, United States
• Duplicate_Rush University Medical Center /ID# 224581 — Chicago, Illinois, United States
• Ochsner Clinic Foundation /ID# 200723 — Baton Rouge, Louisiana, United States
• The Arthritis & Diabetes Clinic, Inc. /ID# 171199 — Monroe, Louisiana, United States
• Ochsner Clinic Foundation-New Orleans /ID# 171200 — New Orleans, Louisiana, United States
• Louisiana State Univ HSC /ID# 202646 — Shreveport, Louisiana, United States
• Rheumatology Associates PA - Portland /ID# 225011 — Portland, Maine, United States
• The Center for Rheumatology and Bone Research /ID# 168652 — Wheaton, Maryland, United States
• Rheum Assoc of North Alabama /ID# 168668 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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