NCT03117270已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 116
- 试验地点
- 30
- 主要终点
- Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
oral filgotinib tablets
Experimental
干预措施: filgotinib (Drug)
placebo tablets
Placebo Comparator
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Ankylosing Spondylitis disease activity score (ASDAS) in filgotinib treated subjects as compared to placebo
时间窗: week 12
To evaluate the effect of filgotinib on the AS disease activity score
次要结局
- Assessment of the Bath Ankylosing Spondylitis Metrology Index in filgotinib treated subjects as compared to placebo(week 12)
- Assessment Spondyloarthritis Research Consortium of Canada MRI in filgotinib treated subjects as compared to placebo(week 12)
- Assessment of the Maastricht Ankylosing Spondylitis Enthesitis Score in filgotinib treated subjects as compared to placebo(week 12)
- Assessment of FACIT fatigue scale in filgotinib treated subjects as compared to placebo(week 12)
- Assessment of SF-36 health survey in filgotinib treated subjects as compared to placebo(week 12)
- Assessment of Ankylosing Spondylitis Quality of Life questionnaire (ASQoL) in filgotinib treated subjects as compared to placebo(week 12)
- Difference between filgotinib treated subjects and placebo subjects in the number of Adverse events(from baseline until the final follow up visit (week 16))
- 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))
- 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))
- 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))
- 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))
- Difference between the number of filgotinib treated subjects and placebo with abnormal radiographic assessment(At baseline and end of study visit (week 12))
- Assessment of SpondyloArthritis international Society (ASAS) in filgotinib treated subjects as compared to placebo(week 12)
- 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)
- Assessement of the Bath Ankylosing Spondylitis Disease Activity Index in filgotinib treated subjects as compared to placebo(week 12)
- Assessment of the Bath Ankylosing Spondylitis Functional Index in filgotinib treated subjects as compared to placebo(week 12)
研究者
研究点 (30)
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