A randomized, double-blind, placebo-controlled, multicenter, Phase II study to assess the efficacy and safety of filgotinib administered for 12 weeks to subjects with active ankylosing spondylitis

Galapagos NV0 个研究点目标入组 116 人开始时间: 2017年2月3日最近更新: 2019年6月30日

适应症

试验速览

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•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 (see protocol) for ankylosing spondylitis at screening, having radiographic sacroiliitis confirmed by central reading (historical radiographs up to 12 months are considered appropriate).
•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.
•Screening serum high-sensitivity CRP (hsCRP) =0.3 mg/dL.
•Have had a documented inadequate response to 2 or more NSAIDs including cyclooxygenase-2 (COX-2) inhibitors at the therapeutic dose range for a total duration of at least 4 weeks (less than 4 weeks permitted in cases of documented intolerance).
•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Use of JAK inhibitors, investigational or approved, at any time, including filgotinib;
•Prior use of more than one TNF inhibitor (including proposed biosimilars with demonstrated equivalence to an approved TNF inhibitor for efficacy in a clinical study), at any time. Prior use of one TNF inhibitor is allowed, with the following minimum washout periods prior to screening:
•- Etanercept: 4 weeks
•- Adalimumab, certolizumab pegol, golimumab: 8 weeks
•- Infliximab: 12 weeks;
•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. If an NSAID or COX-2 inhibitor is used, it must not exceed maximum doses permitted, as per local labeling and must have been used at a stable dose for at least 2 weeks prior to baseline. In addition, subjects are permitted to take acetylsalicylic acid at a dose of =325 mg q.d. for cardiac prophylaxis;
•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.

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