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Evaluation of upadacitinib in adult subjects with axial spondyloarthritis
EU CTIS ID: 2022-501018-78-00
What this study is testing
To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adult subjects with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2); To assess the safety and tolerability of upadacitinib in subjects with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult females and males who are at least 18 years of age
- Remission-Withdrawal Period: There must be no reason the Investigator believes that the subject is an unsuitable candidate to participate in the remission-withdrawal period or receive study drug or would place the subjects at risk by continuing to participate in the study.
- Remission-Withdrawal Period: Subjects must be willing to keep background axSpA medications stable during the Remission-Withdrawal Period.
- Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Study 1: Clinical diagnosis of AS who meet the modified New York Criteria for AS
- Study 1: Subjects must have been exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor (TNF) inhibitor or 1 interleukin [IL]-17 inhibitor) and subject must have discontinued bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to a 2nd bDMARD is allowed for no more than 30% of subjects. Subjects who have had lack of efficacy to 2 bDMARDs (including both a TNF-inhibitor and IL-17 inhibitor) are not eligible.
You likely can't join if
- Subject must not have total spinal ankylosis
- Subjects who have had an inadequate response to both a TNF inhibitor and IL-17 inhibitor are not eligible.
See the full eligibility criteria
- Adult females and males who are at least 18 years of age
- Remission-Withdrawal Period: There must be no reason the Investigator believes that the subject is an unsuitable candidate to participate in the remission-withdrawal period or receive study drug or would place the subjects at risk by continuing to participate in the study.
- Remission-Withdrawal Period: Subjects must be willing to keep background axSpA medications stable during the Remission-Withdrawal Period.
- Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
- Study 1: Clinical diagnosis of AS who meet the modified New York Criteria for AS
- Study 1: Subjects must have been exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis factor (TNF) inhibitor or 1 interleukin [IL]-17 inhibitor) and subject must have discontinued bDMARD therapy due to either lack of efficacy (after at least 12 weeks of treatment with a bDMARD at an adequate dose) or intolerance (irrespective of treatment duration). Prior exposure to a 2nd bDMARD is allowed for no more than 30% of subjects. Subjects who have had lack of efficacy to 2 bDMARDs (including both a TNF-inhibitor and IL-17 inhibitor) are not eligible.
- Study 2: Clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on MRI of sacroiliac joints or based on high sensitivity CRP > ULN.
- Study 2: Prior treatment with at most 1 bDMARD (either 1 TNF inhibitor or 1 IL-17 inhibitor) is allowed in at least 20%, but not exceeding 35% of subjects.
- Must have a BASDAI score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 – 10 numerical rating scale at the Screening and Baseline Visits.
- Remission-Withdrawal Period: Subject must be on study drug upon completion of the Open-Label Extension Period of Study 1 or Study 2 through Week 104.
- Remission-Withdrawal Period: Subject must achieve ASDAS (CRP) < 1.3 at Week 104 and ASDAS (CRP) < 2.1 at Week 88.
- Remission-Withdrawal Period: Subject must not have a newly suspected/acquired medical condition and/or initiate a new medication since the last dose of study drug that would have precluded his/her enrollment into the main study.
- Subject must not have total spinal ankylosis
- Subjects who have had an inadequate response to both a TNF inhibitor and IL-17 inhibitor are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United Kingdom
- United States
- Israel
- Brazil
- Ukraine
- Russian Federation
- Japan
- New Zealand
- Turkey
- Mexico
- Korea, Republic of
- Canada
- China
- Argentina
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United Kingdom; United States; Israel; Brazil; Ukraine and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.