Phase 3
N=429
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Giant Cell Arteritis (GCA)
Bottom Line
View on ClinicalTrials.gov: NCT03725202 ↗Enrolled (actual)
429
Serious AEs
18.9%
Results posted
Mar 2025
Primary outcome: Primary: Percentage of Participants Achieving Sustained Remission at Week 52 — 29.0; 41.1; 46.4 percentage of participants — p==0.0019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Upadacitinib (Drug); Corticosteroid (CS) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Remission at Week 52 |
29.0; 41.1; 46.4 | =0.0019 sig |
| SECONDARY Percentage of Participants Achieving Sustained Complete Remission From Week 12 Through Week 52 |
16.1; 26.2; 37.1 | <0.0001 sig |
| SECONDARY Cumulative Corticosteroid (CS) Exposure Through Week 52 |
2882.0; 1905.0; 1615.0 | <0.0001 sig |
| SECONDARY Time to First Disease Flare Through Week 52 |
323.0; NA; NA | =0.0025 sig |
| SECONDARY Percentage of Participants Who Experience at Least 1 Disease Flare Through Week 52 |
55.6; 41.3; 34.3 | =0.0014 sig |
| SECONDARY Percentage of Participants in Complete Remission at Week 52 |
19.6; 43.0; 50.2 | <0.0001 sig |
| SECONDARY Percentage of Participants in Complete Remission at Week 24 |
36.1; 39.3; 57.2 | =0.0002 sig |
| SECONDARY Change From Baseline in the 36-item Short Form Quality of Life Questionnaire (SF-36) Physical Component Summary (PCS) Score at Week 52 |
-1.2892; 1.3202; 2.4634 | =0.0019 sig |
| SECONDARY Number of Disease Flares Per Participant Through Week 52 |
0.7; 0.6; 0.4 | 0.0010 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Week 52 |
-2.4; 1.1; 1.7 | =0.0036 sig |
| SECONDARY Assessment of Treatment Satisfaction Questionnaire for Medication (TSQM) Patient Global Satisfaction Subscale at Week 52 |
68.8428; 74.2644; 71.5753 | =0.3573 |
| SECONDARY Rate of Corticosteroid-related Adverse Events Though Week 52 |
1.7; 1.7; 2.0 | =0.4371 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03725202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.