Upadacitinib for Axial Spondyloarthritis

(SELECT-AXIS 2 Trial)

Recruiting at 233 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: JAK inhibitors

Disqualifiers: Total spinal ankylosis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

734 Participants Needed

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Study 2: Upadacitinib 15 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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 III: Study 1: Placebo Placebo Group 2 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: Placebo Placebo Group 2 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 European Union, United States, Canada for the following indications:

Approved in European Union as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

Approved in United States as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

Approved in Canada as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis

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

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois