A Phase 3 randomized, placebo-controlled, double-blind, parallel-group program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis

Conditions

axial spondyloarthritis

Brief summary

To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on achieving ASAS40 response (Y/N)

Detailed description

To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDASCRP), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints (SIJs), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation

Related papers

No related papers found yet.

Interventions

DRUGPlacebo-to-match (PTM) tablets will be used in this trial to maintain blinding of the active dose. PTM 200 mg and 100 mg filgotinib tablets are identical in appearance to the respective active filgotinib tablets.

DRUGJyseleca 100 mg film-coated tablets

DRUGJyseleca 200 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on achieving ASAS40 response (Y/N)	—

Secondary

Measure	Time frame
To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDASCRP), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints (SIJs), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on frequency and severity of treatment-emergent adverse events	—

Measure

Time frame

To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDASCRP), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints (SIJs), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) (linear score), To compare the efficacy of filgotinib 200 mg versus placebo at week 16 on frequency and severity of treatment-emergent adverse events

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Countries

Belgium, Bulgaria, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Spain

Outcome results

None listed