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Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease

2016年2月21日 更新者：Galapagos NV

Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

研究概览

地位

完全的

条件

干预/治疗

详细说明

  • 180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated when taking GLPG0634 or matching placebo once daily in addition to their stable background treatment. The population will include 50% anti-TNF naïve patients and 50% of subjects previously exposed to anti-TNF.
  • The study will consist of 2 parts, with total treatment duration of 20 weeks. Randomisation in Part 1 will be stratified according to subject's previous anti-TNF exposure, C-reactive protein (CRP) level at Screening and oral corticosteroid use at Day -1. However, at Week 10, subjects will be re-randomized automatically and stratified according to the subject's clinical response (reduction of Crohn's Disease Activity Index (CDAI) of 100 points), previous anti-TNF exposure and corticosteroid use at Day -1 to receive GLPG0634 200 mg q.d., 100 mg q.d. doses, or matching placebo q.d. in a blinded fashion. In Part 2, all will continue the study until Week 20.
  • As efficacy parameters, the ability to achieve clinical response or remission, endoscopic response & remission as well as mucosal healing with GLPG0634 given once daily compared to placebo will be evaluated after 10 weeks of treatment. In subjects who achieved clinical remission at Week 10, maintenance of the remission will be assessed during Part 2 of the study.
  • During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects of different doses and dose regimens of GLPG0634 administration on subjects' quality of life will be evaluated.

研究类型

介入性

注册 (实际的)

175

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Barnaul、俄罗斯联邦
        • Territorial Clinical Hospital
      • Kazan、俄罗斯联邦
        • State Medical University
      • Krasnoyarsk、俄罗斯联邦
        • Territorial Clinical Hospital
      • Moscow、俄罗斯联邦
        • City Clinical Hospital #24
      • Moscow、俄罗斯联邦
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow、俄罗斯联邦
        • Moscow Clinical Research Center
      • Moscow、俄罗斯联邦
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod、俄罗斯联邦
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk、俄罗斯联邦
        • City Clinical Hospital #12
      • Saint Petersburg、俄罗斯联邦
        • City Clinical Hospital #31
      • Saint Petersburg、俄罗斯联邦
        • First Pavlov State Medical University
      • Saint Petersburg、俄罗斯联邦
        • Mechnikov North-Western State Medical University
      • Saint Petersburg、俄罗斯联邦
        • St. Elizabeth City Hospital
  • 匈牙利
      • Balatonfured、匈牙利
        • Drug Research Center Ltd.
      • Budapest、匈牙利
        • Semmelweis University
      • Budapest、匈牙利
        • ClinExpert Medical Center
      • Budapest、匈牙利
        • Szent Margit Hospital
      • Debrecen、匈牙利
        • University of Debrecen, Medical and Health Science Center
      • Gyula、匈牙利
        • Bekes County Pandy Kalman Hospital
      • Szekszard、匈牙利
        • Tolna County Balassa János Hospital
  • 德国
      • Berlin、德国
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main、德国
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg、德国
        • Asklepios West Hospital Hamburg
      • Jena、德国
        • University Hospital Jena
      • Kiel、德国
        • University Hospital Schleswig-Holstein
      • Magdeburg、德国
        • University Hospital Magdeburg
      • Minden、德国
        • Gastroenterology Group Practice Minden
      • Oldenburg、德国
        • Internal Medicine Group Practice Oldenburg
  • 捷克共和国
      • Hradec Kralove、捷克共和国
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc、捷克共和国
        • University Hospital Olomouc
      • Pilsen、捷克共和国
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague、捷克共和国
        • Institute of Clinical and Experimental Medicine
      • Usti nad Labem、捷克共和国
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo、捷克共和国
        • Hospital Znojmo
  • 比利时
      • Brussels、比利时
        • St. Pierre University Hospital Center
      • Brussels、比利时
        • University Hospital Saint Luc
      • Ghent、比利时
        • University Hospital Ghent
      • Leuven、比利时
        • University Hospitals Leuven
      • Liege、比利时
        • CHR de la CITADELLE
      • Liege、比利时
        • Clinic Saint Joseph
  • 法国
      • Clermont-Ferrand、法国
        • Hospital Gabriel Montpied
      • Clichy、法国
        • Beaujon Hospital
      • Dijon、法国
        • Dijon University Hospital Center
      • Grenoble、法国
        • Hospital Michallon
      • Lille、法国
        • Lille Regional University Hospital Center
      • Marseille、法国
        • North Hospital
      • Nice、法国
        • Archet Hospital
      • Saint Etienne、法国
        • Saint Etienne University Hospital Center
  • 波兰
      • Bydgoszcz、波兰
        • Jan Biziel University Hospital #2
      • Lodz、波兰
        • Saint Family Hospital Medical Center
      • Tychy、波兰
        • H-T. Medical Center
      • Warsaw、波兰
        • Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
      • Warsaw、波兰
        • Vivamed
      • Warsaw、波兰
        • Clinical Hospital of Ministry of Internal Affairs and Administration
      • Wroclaw、波兰
        • Active Health Center
  • 罗马尼亚
      • Bucharest、罗马尼亚
        • Colentina Clinical Hospital
      • Bucharest、罗马尼亚
        • Fundeni Clinical Institute
      • Cluj-Napoca、罗马尼亚
        • Medical Center for Gastroenterology
      • Timisoara、罗马尼亚
        • Center for Gastroenterology, Ltd
  • 英国
      • Birmingham、英国
        • Queen Elizabeth Hospital
      • Bournemouth、英国
        • Royal Bournemouth Hospital
      • Harrow、英国
        • St Mark's Hospital
      • Manchester、英国
        • Manchester Royal Infirmary

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female subjects between 18 and 75 years
  • Documented history of ileal, colonic, or ileocolonic CD
  • CDAI score ≥ 220 to ≤ 450
  • Evidence of active inflammation as demonstrated by endoscopic confirmation of active disease
  • Subjects previously not exposed to anti-TNF treatment (TNF-naïve) or subjects previously exposed to anti-TNF therapy at a registered dose, that has been discontinued at least 8 weeks prior to Screening and deemed by the treating physician as a primary or secondary non-responder or intolerant (TNF-experienced)
  • Continuation of concurrent treatment with oral steroids (≤30 mg prednisolone eq/day), mesalazine, olsalazine, CD-related antibiotics and probiotics at stable dose is allowed
  • Previous exposure to immunomodulators is permitted, but must be discontinued
  • Haematology and biochemistry lab parameters within predefined ranges as stated in the protocol

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC
  • Stoma, gastric or ileoanal pouch, procto- or total colectomy, symptomatic stenosis or obstructive strictures, history of bowel perforation, (suspected) abscess; actively draining fistulae
  • Subject who has had surgical bowel resections within the past 6 months, short bowel syndrome or is receiving tube feeding, defined formula diets, or parenteral alimentation
  • Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection
  • Subject who has received non-permitted IBD therapies within specified timeframes, depending on the medication, as stated in the protocol
  • Subject with a (previous history of) dysplasia of the gastrointestinal tract
  • Concurrent gastro-intestinal malignancy or a history of cancer elsewhere
  • History of lymphoproliferative disease
  • Known active infection of any kind, current therapy for chronic infection or history of specific infections as stated in the protocol
  • Subject who is pregnant, lactating or not willing to maintain highly effective birth control methods during the course of the study and 12 weeks thereafter

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
药品：GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
其他名称：
  • GLPG0634片剂
实验性的：GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
药品：GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
其他名称：
  • GLPG0634片剂
药品：Placebo
placebo oral tablets, intake once daily for 20 weeks
其他名称：
  • 安慰剂片
安慰剂比较：Placebo QD
2 placebo tablets in the morning
药品：Placebo
placebo oral tablets, intake once daily for 20 weeks
其他名称：
  • 安慰剂片

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of subjects achieving clinical remission at Week 10
大体时间：Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

次要结果测量

结果测量
措施说明
大体时间
Percentage of subjects achieving clinical remission
大体时间：Up to Week 20
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving clinical response
大体时间：Up to Week 20
Percentage of subjects achieving clinical response as defined by a decrease in Crohn's Disease Activity Index score of at least 100 points, assessed at every visit
Up to Week 20
Percentage of subjects achieving endoscopic remission at Week 10
大体时间：Week 10
Percentage of subjects achieving endoscopic remission as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score ≤ 4, with ulcerated surface subscore no greater than 1 in any segment at Week 10
Week 10
Percentage of subjects achieving endoscopic response at Week 10
大体时间：Week 10
Percentage of subjects achieving endoscopic response as defined by a reduction of Simplified Endoscopy Score for Crohn's Disease (SES-CD) score by at least 50% from Screening at Week 10
Week 10
Percentage of subjects achieving mucosal healing at Week 10
大体时间：Week 10
Percentage of subjects achieving mucosal healing as defined by a Simplified Endoscopy Score for Crohn's Disease (SES-CD) score equal to 0 at Week 10
Week 10
Change from Baseline in Crohn's Disease Activity Index score
大体时间：Up to Week 20
Change from Baseline in Crohn's Disease Activity Index score, assessed at every visit
Up to Week 20
Change from Screening in endoscopic score
大体时间：Week 10
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
Week 10
Change from Screening in histopathology biopsy score
大体时间：Week 10
Change from Screening in histopathology biopsy score at Week 10
Week 10
Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
大体时间：Up to Week 20
Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
Up to Week 20
The number of subjects with adverse events
大体时间：From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs)
From screening up to 2 weeks after last dose
The number of subjects with abnormal lab tests
大体时间：From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms laboratory test abnormalities
From screening up to 2 weeks after last dose
The number of subjects with abnormal vital signs
大体时间：From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in vital signs
From screening up to 2 weeks after last dose
The number of subjects with abnormal ECG
大体时间：From screening up to 2 weeks after last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of abnormalities in electrocardiogram (ECG)
From screening up to 2 weeks after last dose
The plasma levels of GLPG0634 and its metabolite
大体时间：Up to Week 20
To characterize the pharmacokinetics (PK) of GLPG0634 and its metabolite by measuring the amount in plasma from Week 2 up to Week 20 at every visit
Up to Week 20
The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
大体时间：Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of immune- and inflammation-related parameters in whole blood and serum
Up to Week 20
The change versus Baseline in levels of faecal calprotectin
大体时间：Up to Week 20
To characterize the pharmacodynamics (PD) of GLPG0634 and its metabolite by measuring the levels of faecal calprotectin
Up to Week 20
The change versus Baseline in microbial communities in stool samples
大体时间：Up to Week 10
To characterize the effects of GLPG0634 and its metabolite on the microbial communities by measuring the levels of predominant microbiota in stool samples
Up to Week 10

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Galapagos NV

调查人员

  • 研究主任：Pille Harrison, MD、Galapagos NV

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2014年1月27日

首先提交符合 QC 标准的

2014年1月27日

首次发布 (估计)

2014年1月29日

研究记录更新

最后更新发布 (估计)

2016年2月23日

上次提交的符合 QC 标准的更新

2016年2月21日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GLPG0634-CL-211
  • 2013-002857-32 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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