Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease
21 февраля 2016 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
- 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.
Тип исследования
Интервенционный
Регистрация (Действительный)
175
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Brussels, Бельгия
- St. Pierre University Hospital Center
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Brussels, Бельгия
- University Hospital Saint Luc
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Ghent, Бельгия
- University Hospital Ghent
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Leuven, Бельгия
- University Hospitals Leuven
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Liege, Бельгия
- CHR de la Citadelle
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Liege, Бельгия
- Clinic Saint Joseph
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Balatonfured, Венгрия
- Drug Research Center Ltd.
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Budapest, Венгрия
- Semmelweis University
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Budapest, Венгрия
- ClinExpert Medical Center
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Budapest, Венгрия
- Szent Margit Hospital
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Debrecen, Венгрия
- University of Debrecen, Medical and Health Science Center
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Gyula, Венгрия
- Bekes County Pandy Kalman Hospital
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Szekszard, Венгрия
- Tolna County Balassa Janos Hospital
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Berlin, Германия
- DRK Clinics Berlin Westend
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Frankfurt-am-Main, Германия
- Interdisciplinary Crohn Colitis Center Rhein Main
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Hamburg, Германия
- Asklepios West Hospital Hamburg
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Jena, Германия
- University Hospital Jena
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Kiel, Германия
- University Hospital Schleswig-Holstein
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Magdeburg, Германия
- University Hospital Magdeburg
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Minden, Германия
- Gastroenterology Group Practice Minden
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Oldenburg, Германия
- Internal Medicine Group Practice Oldenburg
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Bydgoszcz, Польша
- Jan Biziel University Hospital #2
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Lodz, Польша
- Saint Family Hospital Medical Center
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Tychy, Польша
- H-T. Medical Center
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Warsaw, Польша
- Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults
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Warsaw, Польша
- Vivamed
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Warsaw, Польша
- Clinical Hospital of Ministry of Internal Affairs and Administration
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Wroclaw, Польша
- Active Health Center
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Barnaul, Российская Федерация
- Territorial Clinical Hospital
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Kazan, Российская Федерация
- State Medical University
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Krasnoyarsk, Российская Федерация
- Territorial Clinical Hospital
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Moscow, Российская Федерация
- City Clinical Hospital #24
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Moscow, Российская Федерация
- A.N. Ryzhikh State Research Center for Coloproctology
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Moscow, Российская Федерация
- Moscow Clinical Research Center
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Moscow, Российская Федерация
- Vladimirsky Regional Clinical Research Institute
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Nizhny Novgorod, Российская Федерация
- Semashko Nizhny Novgorod Regional Clinical Hospital
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Novosibirsk, Российская Федерация
- City Clinical Hospital #12
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Saint Petersburg, Российская Федерация
- City Clinical Hospital #31
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Saint Petersburg, Российская Федерация
- First Pavlov State Medical University
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Saint Petersburg, Российская Федерация
- Mechnikov North-Western State Medical University
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Saint Petersburg, Российская Федерация
- St. Elizabeth City Hospital
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Bucharest, Румыния
- Colentina Clinical Hospital
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Bucharest, Румыния
- Fundeni Clinical Institute
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Cluj-Napoca, Румыния
- Medical Center for Gastroenterology
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Timisoara, Румыния
- Center for Gastroenterology, Ltd
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Birmingham, Соединенное Королевство
- Queen Elizabeth Hospital
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Bournemouth, Соединенное Королевство
- Royal Bournemouth Hospital
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Harrow, Соединенное Королевство
- St Mark's Hospital
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Manchester, Соединенное Королевство
- Manchester Royal Infirmary
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Clermont-Ferrand, Франция
- Hospital Gabriel Montpied
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Clichy, Франция
- Beaujon Hospital
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Dijon, Франция
- Dijon University Hospital Center
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Grenoble, Франция
- Hospital Michallon
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Lille, Франция
- Lille Regional University Hospital Center
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Marseille, Франция
- North Hospital
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Nice, Франция
- Archet Hospital
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Saint Etienne, Франция
- Saint Etienne University Hospital Center
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Hradec Kralove, Чешская Республика
- Hepato-Gastroenterology HK Ltd.
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Olomouc, Чешская Республика
- University Hospital Olomouc
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Pilsen, Чешская Республика
- Outpatient Clinic of Internal Medicine and Gastroenterology
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Prague, Чешская Республика
- Institute of clinical and experimental medicine
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Usti nad Labem, Чешская Республика
- Masaryk's Hospital Usti Nad Labem
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Znojmo, Чешская Республика
- Hospital Znojmo
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 75 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: GLPG0634 200 mg QD
2 tablets of 100 mg GLPG0634 in the morning
|
100 mg oral tablet, intake once daily for 20 weeks
Другие имена:
|
|
Экспериментальный: GLPG0634 100 mg QD
1 tablet of 100 mg GLPG0634 and 1 placebo tablet in the morning
|
100 mg oral tablet, intake once daily for 20 weeks
Другие имена:
placebo oral tablets, intake once daily for 20 weeks
Другие имена:
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Плацебо Компаратор: Placebo QD
2 placebo tablets in the morning
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placebo oral tablets, intake once daily for 20 weeks
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of subjects achieving clinical remission at Week 10
Временное ограничение: Week 10
|
Percentage of subjects achieving clinical remission as defined by a Crohn's Disease Activity Index score < 150 points
|
Week 10
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of subjects achieving clinical remission
Временное ограничение: 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
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Up to Week 20
|
|
Percentage of subjects achieving clinical response
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
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Week 10
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Percentage of subjects achieving mucosal healing at Week 10
Временное ограничение: Week 10
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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
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Week 10
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|
Change from Baseline in Crohn's Disease Activity Index score
Временное ограничение: 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
Временное ограничение: Week 10
|
Change from Screening in endoscopic Simplified Endoscopy Score for Crohn's Disease (SES-CD) score at Week 10
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Week 10
|
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Change from Screening in histopathology biopsy score
Временное ограничение: Week 10
|
Change from Screening in histopathology biopsy score at Week 10
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Week 10
|
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Change from Baseline in Subjects' Quality of Life (based on the Inflammatory Bowel Disease Questionnaire (IBDQ) questionnaire score)
Временное ограничение: Up to Week 20
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Change from Baseline in Subjects' Quality of Life based on the IBDQ questionnaire score at Week 10 and Week 20
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Up to Week 20
|
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The number of subjects with adverse events
Временное ограничение: 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
Временное ограничение: 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
|
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The number of subjects with abnormal vital signs
Временное ограничение: 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
|
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The number of subjects with abnormal ECG
Временное ограничение: 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
|
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The plasma levels of GLPG0634 and its metabolite
Временное ограничение: 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
|
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The change versus Baseline in levels of immune- and inflammation-related parameters in whole blood and serum
Временное ограничение: 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
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Up to Week 20
|
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The change versus Baseline in levels of faecal calprotectin
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Pille Harrison, MD, Galapagos NV
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 февраля 2014 г.
Первичное завершение (Действительный)
1 ноября 2015 г.
Завершение исследования (Действительный)
1 февраля 2016 г.
Даты регистрации исследования
Первый отправленный
27 января 2014 г.
Впервые представлено, что соответствует критериям контроля качества
27 января 2014 г.
Первый опубликованный (Оценивать)
29 января 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
23 февраля 2016 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 февраля 2016 г.
Последняя проверка
1 февраля 2016 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GLPG0634-CL-211
- 2013-002857-32 (Номер EudraCT)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .