SELECT-AXIS 2
Brief summary
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 an active drug compared with placebo on reduction of signs and symptoms in adult participants 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 an active drug in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2).
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Study 1:
- Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the
modified New York Criteria for AS,
- Must not have total spinal ankylosis
- Must have been previously exposed to 1 or 2 bDMARDs (at least 1 tumor necrosis
factor [TNF] inhibitor or 1 interleukin [IL]-17 inhibitor [IL-17i]), and must
have discontinued the 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 two bDMARDs was allowed
for no more than 30% of patients; among patients with prior exposure to two
bDMARDs, a lack of efficacy to one bDMARD and intolerance to another was
permitted, but a patient could not have a lack of efficacy to two bDMARDs
- Study 2:
- Must have a clinical diagnosis of nr-axSpA fulfilling the 2009 Assessment of
SpondyloArthritis international Society (ASAS) classification criteria for
axSpA but not meeting the radiologic criterion of the modified New York
criteria for AS
- Must have objective signs of active inflammation consistent with axSpA on
magnetic resonance imaging (MRI) of sacroiliac (SI) joints or based on high
sensitivity C-reactive protein (hsCRP) > the upper limit of normal (ULN).
- Prior treatment with at most one bDMARD (either TNF inhibitor or IL-17i) is
allowed for at least 20% but no more than 35% of enrolled patients who had to
discontinue the prior bDMARD due to either lack of efficacy (after ≥ 12 weeks
at an adequate dose) or intolerance (regardless of treatment duration).
- Must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at
the Screening and Baseline Visits.
- Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at
the Screening and Baseline Visits.
- Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs
(NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated
doses, or has an intolerance to or contraindication for NSAIDs as defined by the
Investigator.
Exclusion Criteria:
- Must not have been exposed to any Janus kinase (JAK) inhibitor (including but not
limited to upadacitinib [Rinvoq®], tofacitinib [Xeljanz®], baricitinib [Olumiant®],
filgotinib, ruxolitinib [Jakafi®], abrocitinib [PF-04965842], and peficitinib
[Smyraf®]).
- Prior bDMARD therapy must be washed out.
- Participant must not have a history of an allergic reaction or significant
sensitivity to constituents of the study drug.
