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

Conditions

• Giant Cell Arteritis (GCA)

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Corticosteroid (CS) — DRUG
  At Baseline, all participants switched to corticosteroids (CS) provided by the sponsor with the oral prednisone or prednisolone dose at 20, 30, 40, 50, or 60 mg QD. The initial dose of prednisone or prednisolone was at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 20 mg QD at Baseline. At Baseline, if a participant was on a dose other than 20, 30, 40, 50, or 60 mg QD, the dose was rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. Prednisone or prednisolone was tapered according to a predefined schedule over a 26- or 52-week period. Open-label prednisone or prednisolone was provided until the dose was tapered to 20 mg/day. Subsequently, blinded prednisone or prednisolone was provided for the remaining blinded taper regimen through Week 52.
• Placebo — OTHER
  Administered orally once a day
• Upadacitinib — DRUG
  Administered orally once a day

Study Details

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 Dates

Start date

Jan 24, 2019

Status verified

Feb 2026

Primary completion

Feb 6, 2024

Completion

Mar 11, 2025

Study Design

Enrollment

429 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo + 52-week CS taper
  Participants received placebo tablets for upadacitinib administered orally once daily (QD) for 52 weeks and a 52-week corticosteroid (CS) taper regimen during Period 1.
• Experimental: 7.5 mg Upadacitinib + 26-week CS taper
  Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
• Experimental: 15 mg Upadacitinib + 26-week CS taper
  Participants received 15 mg upadacitinib tablets administered orally once daily (QD) for 52 weeks and a 26-week corticosteroid (CS) taper regimen during Period 1.
• Placebo Comparator: Placebo + 52-week CS taper -> Placebo
  Participants who achieved sustained remission for at least 24 weeks prior to the Week 52 visit (at the end of Period 1) OR at remission at the Week 52 visit only who were assigned to placebo tablets for upadacitinib administered orally once daily (QD) in Period 1 continued to receive placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
• Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg Upadacitinib
  Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
• Experimental: 7.5 mg Upadacitinib + 26-week CS taper -> Placebo
  Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.
• Experimental: 15 mg Upadacitinib + 26-week CS taper -> 15 mg Upadacitinib
  Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.
• Experimental: 15 mg Upadacitinib + 26-week CS taper -> Placebo
  Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Primary Outcome Measure

Percentage of Participants Achieving Sustained Remission at Week 52 [ Time Frame: From Week 12 to Week 52 ]

Locations (53)

Related coverage on Hipa.ai

• Upadacitinib Shows Improved Remission, Reduced Corticosteroid Use in Giant…
  Upadacitinib · Mar 7, 2025 · ClinicalTrials.gov

Find similar trials in Huntsville, AL

Related Studies

• Tocilizumab Discontinuation Versus Dose Reduction for Patients With Well-Controlled Giant Cell Arteritis
  PHASE2 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Atlanta, Georgia