NCT03101670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 16 Weeks to Subjects With Moderately to Severely Active Psoriatic Arthritis
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
- 131
- 试验地点
- 25
- 主要终点
- Percentage of subjects who have reached ACR20 response 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 moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response or are intolerant to conventional disease-modifying therapy. A total of approximately 124 subjects will be randomized to one of 2 treatment arms in a 1:1 ratio: oral filgotinib tablets q.d. or matching placebo tablets q.d. The Screening visit will occur within 28 days before study drug administration. At Day 1 (Baseline), eligible subjects will be randomized to treatment for a duration of 16 weeks. The study is concluded with a Follow-up period lasting until 4 weeks after the last dose. Consequently, each subject will stay in the study for a maximum of 24 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 psoriatic arthritis meeting Classification Criteria for Psoriatic Arthritis (CASPAR)
- •Have active psoriatic arthritis defined as ≥5 swollen joints (from a 66 swollen joint count [SJC]) and ≥5 tender joints (from a 68 tender joint count [TJC]) at Screening and Baseline (measurable dactylitis of a digit counts as a single swollen joint and if tender, then also a single tender joint).
- •Have had a history of documented plaque psoriasis or currently active plaque psoriasis
- •If using cDMARD therapy, subjects must have been on it for 12 weeks prior to screening, with a stable dose (including stable route of administration) for at least 4 weeks prior to baseline.
- •If using non-drug therapies (including physical therapies), thse should be kept sable 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 cyclooxygenase-2 (COX-2) inhibitor.
- •Have undergone surgical treatment for psoriatic arthritis including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to screening
- •Presence of very poor functional status or unable to perform self-care.
- •Administration of a live or attenuated vaccine within 12 weeks prior to baseline
研究组 & 干预措施
filgotinib
Experimental
干预措施: filgotinib (Drug)
placebo
Placebo Comparator
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percentage of subjects who have reached ACR20 response as compared to placebo
时间窗: Week 16
To assess the effect of filogotinib on PsA as assessed by ACR20 in PsA patients
次要结局
- Assessment of minimal disease activity (MDA) in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects achieving DAS28(CRP) score as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of joints for tenderness (68) and swelling (66) in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Psoriasis as assessed by PASI75 in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects who have reached ACR50 response as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects who have reached ACR70 response as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects achieving CDAI response as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Psoriasis as assessed by PASI50 in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects achieving SDAI response as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of psoriatic arthritis response criteria (PsARC) as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Percentage of subjects achieving EULAR response as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of physician's and patient's global assessment of disease activity as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of patient's global assessment of PsA pain intensity in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Psoriasis as assessed by PASI100 in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal physical examination(From screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal ECG(From screening until the final follow up visit (week 20))
- Assessment of CRP in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Psoriasis as assessed by PASI in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Physician's and patient's global assessment of psoriasis in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Physical function as assessed by HAQ-DI in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- FACIT-Fatigue scale in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of SF-36 in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal radiographic assessment(From screening until the final follow up visit (week 20))
- Psoriasis as assessed by PASI90 in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of mNAPSI in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of Psoriatic Arthritis Impact of Disease Questionnaire (PsAID) in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Assessment of pruritis NRS in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Enthesitis as assessed by SPARCC enthesitis index in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects in the number of adverse events(From screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal vital signs(From screening until the final follow up visit (week 20))
- Dactilytis as assessed by LDI in filgotinib treated subjects as compared to placebo(At each visit from screening until the final follow up visit (week 20))
- Difference between the number of filgotinib treated subjects and placebo subjects with abnormal clinical laboratory evaluations(From screening until the final follow up visit (week 20))
研究者
研究点 (25)
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