Ankylosing Spondylitis
Conditions
Brief summary
This is a multicenter, Phase 2, double-blind, placebo-controlled study in subjects with active Ankylosing Spondylitis (AS). A total of approximately 100 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo q.d. Treatment duration will be 12 weeks. Each subject will stay in the study for a maximum of 20 weeks (from Screening visit to Follow-up visit).
Interventions
DRUGfilgotinib
one filgotinib oral tablet q.d.
DRUGPlacebo Oral Tablet
one placebo oral tablet q.d.
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female subjects who are ≥18 years of age on the day of signing informed consent. * Diagnosis of moderate to severe ankylosing spondylitis with documented evidence of fulfilling the Modified New York (NY) criteria * Have active ankylosing spondylitis with a BASDAI ≥4 (numeric rating scale \[NRS\] 0-10) and spinal pain ≥4 (0-10 NRS) (based on BASDAI question 2, see protocol) at screening and baseline. * Have had a documented inadequate response to NSAIDs including cyclooxygenase-2 (COX-2) inhibitors. * If using cDMARD therapy, stable dose for at lead 4 weeks prior to Baseline. * If using non-drug therapies (including physical therapies), these should be kept stable during screening. * Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use highly effective methods of contraception as described in the protocol. Key
Exclusion criteria
* Use of JAK inhibitors, investigational or approved, at any time, including filgotinib; * Prior use of more than one TNF inhibitor, at any time. * Use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that hasn't been stable for at least 4 weeks prior to baseline; * Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronate) within 4 weeks prior to screening; * Use of more than 1 NSAID or COX-2 inhibitor. * Contraindication to MRI. * History of known or suspected complete ankylosis of the spine. * Presence of very poor functional status or unable to perform self-care. * Have undergone surgical treatment for ankylosing spondylitis within the last 12 weeks prior to screening. * Administration of a live or attenuated vaccine within 12 weeks prior to baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo | week 12 | To evaluate the effect of filgotinib on the AS disease activity score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment by a trained joint assessor of 44 joints for tenderness (counting the number or tender joints - TJC) and swelling (counting the number of swollen joints - SJC) in filgotinib treated subjects as compared to placebo | week 12 | To evaluate the effect of filgotinib on joint tenderness and swelling in AS patient |
| Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on BAS disease activity index in AS patients |
| Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on BAS functional index in AS patients |
| Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on BAS metrology index in AS patients |
| Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filogtinib on Spondyloarthritis Research Consortium of Canada MRI in AS patients |
| Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinibe on Maastricht Ankylosing Spondylitis Enthesitis Score in AS patients |
| Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on FACIT fatigue scale in AS patients |
| Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo | week 12 | To evaluation the effect of filgotinib on the ASAS score in AS patients |
| Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on ASQoL in AS patients |
| Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events | from baseline until the final follow up visit (week 16) | To assess safety and tolerability of filgotinib in AS patients |
| Difference in the number of filgotinib subjects and placebo subjects with abnormal Clinical laboratory evaluations | from baseline until the final follow up visit (week 16) | To assess safety and tolerability of filgotinib in AS patients |
| Difference in the number of filgotinib treated subjects and placebo subjects with abnormal vital signs | from baseline until the final follow up visit (week 16) | To assess safety and tolerability of filgotinib in AS patients |
| Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination | from baseline until the final follow up visit (week 16) | To assess safety and tolerability of filgotinib in AS patients |
| Difference between the number of filgotinib treated subjects and placebo with abnormal ECG | At baseline, end of study visit (week 12) and final follow up visit (week 16) | To assess safety and tolerability of filgotinib in AS patients |
| Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment | At baseline and end of study visit (week 12) | To assess safety and tolerability of filgotinib in AS patients |
| Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo | week 12 | To assess the effect of filgotinib on SF-36 health survey in AS patients |
Countries
Belgium, Bulgaria, Czechia, Estonia, Poland, Spain, Ukraine
Outcome results
None listed