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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04169373




Registration number
NCT04169373
Ethics application status
Date submitted
18/11/2019
Date registered
19/11/2019
Date last updated
6/05/2023

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Scientific title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period
Secondary ID [1] 0 0
2022-501018-78-00
Secondary ID [2] 0 0
M19-944
Universal Trial Number (UTN)
Trial acronym
SELECT-AXIS 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo

Experimental: Study 1: Upadacitinib 15 mg - 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).

Placebo Comparator: Study 1: Placebo - 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).

Experimental: Study 2: Upadacitinib 15 mg - 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).

Placebo Comparator: Study 2: Placebo - 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).


Treatment: Drugs: Upadacitinib
Upadacitinib tablet administered orally

Treatment: Drugs: Placebo
Placebo for upadacitinib tablet administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14
Timepoint [1] 0 0
Baseline and Week 14
Primary outcome [2] 0 0
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
Timepoint [2] 0 0
Baseline and Week 14
Secondary outcome [1] 0 0
Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14
Timepoint [1] 0 0
Baseline and Week 14
Secondary outcome [2] 0 0
Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14
Timepoint [2] 0 0
Baseline and Week 14
Secondary outcome [3] 0 0
Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14
Timepoint [3] 0 0
Baseline and Week 14
Secondary outcome [4] 0 0
Study 1: Percentage of Participants With an ASAS20 Response at Week 14
Timepoint [4] 0 0
Baseline and Week 14
Secondary outcome [5] 0 0
Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Timepoint [6] 0 0
Baseline and Week 14
Secondary outcome [7] 0 0
Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Timepoint [7] 0 0
Baseline and Week 14
Secondary outcome [8] 0 0
Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Timepoint [8] 0 0
Week 14
Secondary outcome [9] 0 0
Study 1: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Timepoint [9] 0 0
Baseline and Week 14
Secondary outcome [10] 0 0
Study 1: Percentage of Participants With ASAS Partial Remission at Week 14
Timepoint [10] 0 0
Week 14
Secondary outcome [11] 0 0
Study 1: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Week 14
Timepoint [11] 0 0
Baseline and Week 14
Secondary outcome [12] 0 0
Study 1: Change From Baseline in ASAS Health Index at Week 14
Timepoint [12] 0 0
Baseline and Week 14
Secondary outcome [13] 0 0
Study 1: Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14
Timepoint [13] 0 0
Baseline and Week 14
Secondary outcome [14] 0 0
Study 1: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14
Timepoint [14] 0 0
Baseline and Week 14
Secondary outcome [15] 0 0
Study 1: Change From Baseline in MRI SPARCC Score for Sacroiliac Joints at Week 14
Timepoint [15] 0 0
Baseline and Week 14
Secondary outcome [16] 0 0
Study 2: Change From Baseline in ASDAS at Week 14
Timepoint [16] 0 0
Baseline and Week 14
Secondary outcome [17] 0 0
Study 2: Change From Baseline in MRI SPARCC Score for SI Joints at Week 14
Timepoint [17] 0 0
Baseline and Week 14
Secondary outcome [18] 0 0
Study 2: Percentage of Participants With BASDAI 50 Response at Week 14
Timepoint [18] 0 0
Baseline and Week 14
Secondary outcome [19] 0 0
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 14
Timepoint [19] 0 0
Week 14
Secondary outcome [20] 0 0
Study 2: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14
Timepoint [20] 0 0
Baseline and Week 14
Secondary outcome [21] 0 0
Study 2: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14
Timepoint [21] 0 0
Baseline and Week 14
Secondary outcome [22] 0 0
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 14
Timepoint [22] 0 0
Week 14
Secondary outcome [23] 0 0
Study 2: Percentage of Participants With ASAS Partial Remission at Week 14
Timepoint [23] 0 0
Week 14
Secondary outcome [24] 0 0
Study 2: Change From Baseline in BASFI at Week 14
Timepoint [24] 0 0
Baseline and Week 14
Secondary outcome [25] 0 0
Study 2: Change From Baseline in ASQoL at Week 14
Timepoint [25] 0 0
Baseline and Week 14
Secondary outcome [26] 0 0
Study 2: Change From Baseline in ASAS Health Index at Week 14
Timepoint [26] 0 0
Baseline and Week 14
Secondary outcome [27] 0 0
Study 2: Percentage of Participants Achieving an ASAS20 Response at Week 14
Timepoint [27] 0 0
Baseline and Week 14
Secondary outcome [28] 0 0
Study 2: Change From Baseline in BASMI(Lin) at Week 14
Timepoint [28] 0 0
Baseline and Week 14
Secondary outcome [29] 0 0
Study 2: Change From Baseline in MASES at Week 14
Timepoint [29] 0 0
Baseline and Week 14
Secondary outcome [30] 0 0
Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 52
Timepoint [30] 0 0
Baseline and Week 52
Secondary outcome [31] 0 0
Study 2: Change From Baseline in MRI SPARCC Score for the Spine at Week 14
Timepoint [31] 0 0
Baseline and Week 14
Secondary outcome [32] 0 0
Study 2: Percentage of Participants Who Initiated Rescue Treatment Between Week 24 and Week 52
Timepoint [32] 0 0
Week 24, Week 32, Week 40, and Week 52
Secondary outcome [33] 0 0
Study 2: Percentage of Participants With ASDAS Major Improvement at Week 52
Timepoint [33] 0 0
Baseline and Week 52
Secondary outcome [34] 0 0
Study 2: Percentage of Participants With ASDAS Inactive Disease at Week 52
Timepoint [34] 0 0
Week 52
Secondary outcome [35] 0 0
Study 2: Percentage of Participants With ASDAS Low Disease Activity at Week 52
Timepoint [35] 0 0
Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
Accrual to date
Final
734
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Emeritus Research Sydney /ID# 215507 - Botany
Recruitment hospital [2] 0 0
BJC Health /ID# 215510 - Paramatta
Recruitment hospital [3] 0 0
Emeritus Research /ID# 215506 - Camberwell
Recruitment hospital [4] 0 0
Monash Medical Centre /ID# 215509 - Clayton
Recruitment hospital [5] 0 0
Barwon Rheumatology Services /ID# 215508 - Geelong
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment outside Australia
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Norfolk
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Suffolk
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Armthorpe Road

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04169373
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for public queries
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Contact person for scientific queries