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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

  • 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.

研究の種類

介入

入学 (実際)

175

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • Birmingham、イギリス
        • Queen Elizabeth Hospital
      • Bournemouth、イギリス
        • Royal Bournemouth Hospital
      • Harrow、イギリス
        • St Mark's Hospital
      • Manchester、イギリス
        • Manchester Royal Infirmary
  • チェコ共和国
      • Hradec Kralove、チェコ共和国
        • Hepato-Gastroenterology HK Ltd.
      • Olomouc、チェコ共和国
        • University Hospital Olomouc
      • Pilsen、チェコ共和国
        • Outpatient Clinic of Internal Medicine and Gastroenterology
      • Prague、チェコ共和国
        • Institute of clinical and experimental medicine
      • Usti nad Labem、チェコ共和国
        • Masaryk's Hospital Usti Nad Labem
      • Znojmo、チェコ共和国
        • Hospital Znojmo
  • ドイツ
      • Berlin、ドイツ
        • DRK Clinics Berlin Westend
      • Frankfurt-am-Main、ドイツ
        • Interdisciplinary Crohn Colitis Center Rhein Main
      • Hamburg、ドイツ
        • Asklepios West Hospital Hamburg
      • Jena、ドイツ
        • University Hospital Jena
      • Kiel、ドイツ
        • University Hospital Schleswig-Holstein
      • Magdeburg、ドイツ
        • University Hospital Magdeburg
      • Minden、ドイツ
        • Gastroenterology Group Practice Minden
      • Oldenburg、ドイツ
        • Internal Medicine Group Practice Oldenburg
  • ハンガリー
      • Balatonfured、ハンガリー
        • Drug Research Center Ltd.
      • Budapest、ハンガリー
        • Semmelweis University
      • Budapest、ハンガリー
        • ClinExpert Medical Center
      • Budapest、ハンガリー
        • Szent Margit Hospital
      • Debrecen、ハンガリー
        • University of Debrecen, Medical and Health Science Center
      • Gyula、ハンガリー
        • Bekes County Pandy Kalman Hospital
      • Szekszard、ハンガリー
        • Tolna County Balassa Janos Hospital
  • フランス
      • Clermont-Ferrand、フランス
        • Hospital Gabriel Montpied
      • Clichy、フランス
        • Beaujon Hospital
      • Dijon、フランス
        • Dijon University Hospital Center
      • Grenoble、フランス
        • Hospital Michallon
      • Lille、フランス
        • Lille Regional University Hospital Center
      • Marseille、フランス
        • North Hospital
      • Nice、フランス
        • Archet Hospital
      • Saint Etienne、フランス
        • Saint Etienne University Hospital Center
  • ベルギー
      • Brussels、ベルギー
        • St. Pierre University Hospital Center
      • Brussels、ベルギー
        • University Hospital Saint Luc
      • Ghent、ベルギー
        • University Hospital Ghent
      • Leuven、ベルギー
        • University Hospitals Leuven
      • Liege、ベルギー
        • CHR de la Citadelle
      • Liege、ベルギー
        • Clinic Saint Joseph
  • ポーランド
      • Bydgoszcz、ポーランド
        • Jan Biziel University Hospital #2
      • Lodz、ポーランド
        • Saint Family Hospital Medical Center
      • Tychy、ポーランド
        • H-T. Medical Center
      • Warsaw、ポーランド
        • Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
      • Warsaw、ポーランド
        • Vivamed
      • Warsaw、ポーランド
        • Clinical Hospital of Ministry of Internal Affairs and Administration
      • Wroclaw、ポーランド
        • Active Health Center
  • ルーマニア
      • Bucharest、ルーマニア
        • Colentina Clinical Hospital
      • Bucharest、ルーマニア
        • Fundeni Clinical Institute
      • Cluj-Napoca、ルーマニア
        • Medical Center for Gastroenterology
      • Timisoara、ルーマニア
        • Center for Gastroenterology, Ltd
  • ロシア連邦
      • Barnaul、ロシア連邦
        • Territorial Clinical Hospital
      • Kazan、ロシア連邦
        • State Medical University
      • Krasnoyarsk、ロシア連邦
        • Territorial Clinical Hospital
      • Moscow、ロシア連邦
        • City Clinical Hospital #24
      • Moscow、ロシア連邦
        • A.N. Ryzhikh State Research Center for Coloproctology
      • Moscow、ロシア連邦
        • Moscow Clinical Research Center
      • Moscow、ロシア連邦
        • Vladimirsky Regional Clinical Research Institute
      • Nizhny Novgorod、ロシア連邦
        • Semashko Nizhny Novgorod Regional Clinical Hospital
      • Novosibirsk、ロシア連邦
        • City Clinical Hospital #12
      • Saint Petersburg、ロシア連邦
        • City Clinical Hospital #31
      • Saint Petersburg、ロシア連邦
        • First Pavlov State Medical University
      • Saint Petersburg、ロシア連邦
        • Mechnikov North-Western State Medical University
      • Saint Petersburg、ロシア連邦
        • St. Elizabeth City Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
薬：GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
他の名前：
  • GLPG0634錠
実験的：GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
薬：GLPG0634
100 mg oral tablet, intake once daily for 20 weeks
他の名前：
  • GLPG0634錠
薬：Placebo
placebo oral tablets, intake once daily for 20 weeks
他の名前：
  • プラセボ錠
プラセボコンパレーター：Placebo QD
2 placebo tablets in the morning
薬：Placebo
placebo oral tablets, intake once daily for 20 weeks
他の名前：
  • プラセボ錠

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of subjects achieving clinical remission at Week 10
時間枠：Week 10
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
Week 10

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of subjects achieving clinical remission
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Galapagos NV

捜査官

  • スタディディレクター：Pille Harrison, MD、Galapagos NV

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年2月1日

一次修了 (実際)

2015年11月1日

研究の完了 (実際)

2016年2月1日

試験登録日

最初に提出

2014年1月27日

QC基準を満たした最初の提出物

2014年1月27日

最初の投稿 (見積もり)

2014年1月29日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月23日

QC基準を満たした最後の更新が送信されました

2016年2月21日

最終確認日

2016年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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