Upadacitinib for Axial Spondyloarthritis
(SELECT-AXIS 2 Trial)

Recruiting in Palo Alto (17 mi)

+233 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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: * To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). * To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). * To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). * To evaluate the maintenance of disease control after withdrawal of upadacitinib.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Adults with active axial spondyloarthritis, including those who didn't respond well to certain rheumatic disease treatments (bDMARDs), can join this trial. Participants must have a specific level of disease activity and back pain, and not be fully fused in the spine due to ankylosis. They shouldn't have used JAK inhibitors before or be allergic to study drug ingredients.

Inclusion Criteria

You are allowed to participate in the study if you have received bDMARD therapy before.

My arthritis did not improve with biologic medication.

Study 1: You have been diagnosed with ankylosing spondylitis (AS) and meet specific criteria called the modified New York Criteria for AS. OR Study 2: You have been diagnosed with non-radiographic axial spondyloarthritis (nr-axSpA) and meet specific criteria called the ASAS classification criteria for axSpA. You also have active inflammation shown on MRI or have high sensitivity C-reactive protein (CRP) levels.

See 3 more

Exclusion Criteria

I have stopped taking any biologic DMARDs as required.

I have never taken any JAK inhibitor medications.

You cannot have had an allergic reaction or severe sensitivity to the study drug.

Treatment Details

Interventions

Placebo (Drug)
Upadacitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe trial is testing Upadacitinib's effectiveness compared to a placebo in reducing symptoms for two groups: one with ankylosing spondylitis (AS) that didn’t respond well to bDMARDs, and another with non-radiographic axial spondyloarthritis (nr-axSpA). It also looks at how safe and tolerable the drug is over time.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Study 2: Upadacitinib 15 mgExperimental Treatment1 Intervention

Participants receive 15 mg upadacitinib orally once a day for 104 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Group II: Study 1: Upadacitinib 15 mgExperimental Treatment1 Intervention

Group III: Study 1: PlaceboPlacebo Group2 Interventions

Participants receive matching placebo for 14 weeks and then switch to receive 15 mg upadacitinib orally once a day for 90 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Group IV: Study 2: PlaceboPlacebo Group2 Interventions

Participants receive matching placebo for 52 weeks and then switch to receive 15 mg upadacitinib orally once a day for 52 weeks. Participants who flare after 104 weeks will receive open-label upadacitinib once daily from the time of flare for 24 weeks (re-treatment).

Upadacitinib is already approved in Canada for the following indications: