734 Participants Needed

Upadacitinib for Axial Spondyloarthritis

(SELECT-AXIS 2 Trial)

Recruiting at 233 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.
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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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Period

Participants are randomized to receive either upadacitinib or placebo

14 weeks for Study 1, 52 weeks for Study 2

Open-Label Extension Period

Participants receive open-label upadacitinib after the double-blind period

90 weeks for Study 1, 52 weeks for Study 2

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Remission-Withdrawal Period

Participants in remission at Week 104 have the option to enroll in a remission-withdrawal period

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Upadacitinib
Trial Overview The 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 2: Upadacitinib 15 mgExperimental Treatment1 Intervention
Group II: Study 1: Upadacitinib 15 mgExperimental Treatment1 Intervention
Group III: Study 1: PlaceboPlacebo Group2 Interventions
Group IV: Study 2: PlaceboPlacebo Group2 Interventions

Upadacitinib is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Rinvoq for:
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Approved in United States as Rinvoq for:
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Approved in Canada as Rinvoq for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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