Upadacitinib for Giant Cell Arteritis
(SELECT-GCA Trial)

Recruiting in Palo Alto (17 mi)

+212 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if upadacitinib, combined with reducing steroid doses, helps people with giant cell arteritis achieve and maintain remission by reducing inflammation. Upadacitinib has been approved for the treatment of rheumatoid arthritis, atopic dermatitis, and psoriatic arthritis, and is under investigation for other conditions.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with Giant Cell Arteritis (GCA) who've been treated with high-dose steroids. They must have stable GCA suitable for a steroid tapering regimen and not have used JAK inhibitors or IL-6 inhibitors recently. Women must be non-reproductive or use birth control.

Inclusion Criteria

I have been diagnosed with giant cell arteritis.

I have been treated with high-dose steroids before and am currently on a daily dose.

My giant cell arteritis is stable enough to start reducing my steroid treatment.

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Exclusion Criteria

I have previously taken a JAK inhibitor medication.

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

I have not taken IL-6 inhibitors in the last 4 weeks or had a disease flare on them.

See 2 more

Treatment Details

Interventions

Corticosteroid (CS) (Corticosteroid)
Placebo (Other)
Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe study tests Upadacitinib's effectiveness and safety in GCA patients, comparing a combination of the drug with a 26-week steroid taper to placebo with a longer, 52-week taper. It also examines if continuing Upadacitinib maintains remission after initial success.

Participant Groups

8Treatment groups

Experimental Treatment

Placebo Group

Group I: 7.5 mg Upadacitinib + 26-week CS taper -> PlaceboExperimental Treatment1 Intervention

Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Group II: 7.5 mg Upadacitinib + 26-week CS taper -> 7.5 mg UpadacitinibExperimental Treatment1 Intervention

Participants received 7.5 mg upadacitinib tablets administered orally once daily (QD) in Period 2.

Group III: 7.5 mg Upadacitinib + 26-week CS taperExperimental Treatment2 Interventions

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.

Group IV: 15 mg Upadacitinib + 26-week CS taper -> PlaceboExperimental Treatment1 Intervention

Participants received placebo tablets for upadacitinib administered orally once daily (QD) in Period 2.

Group V: 15 mg Upadacitinib + 26-week CS taper -> 15 mg UpadacitinibExperimental Treatment1 Intervention

Participants received 15 mg upadacitinib tablets administered orally once daily (QD) in Period 2.

Group VI: 15 mg Upadacitinib + 26-week CS taperExperimental Treatment2 Interventions

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.

Group VII: Placebo + 52-week CS taperPlacebo Group2 Interventions

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.

Group VIII: Placebo + 52-week CS taper -> PlaceboPlacebo Group1 Intervention

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.