Исследование по изучению долгосрочной безопасности, переносимости и эффективности Балинатунфиба у пациентов с болезнью Крона или язвенным колитом (СПЕЦИФИ-ВЗК-ДБ)
Многонациональное, многоцентровое расширенное исследование по изучению долгосрочной безопасности, переносимости и эффективности Балинатунфиба у взрослых с болезнью Крона или язвенным колитом
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively.
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The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period.
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The study will consist of 2 independent cohorts through the study given the distinct nature of each disease:
- CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212).
- UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822).
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The study will consist of the following study periods for each cohort:
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A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies.
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An Open-Label (OL) treatment period of up to 104 weeks for:
- Eligible participants from either the DB or OL periods of the parent studies,
- Eligible participants who meet escape criteria at any time during the DB period of the LTS19689.
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A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.
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Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Buenos Aires, Аргентина, 1061
- Investigational Site Number : 0320001
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Gorna Oryahovitsa, Болгария, 5100
- Investigational Site Number : 1000001
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Milano
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Milan, Milano, Италия, 20132
- Investigational Site Number : 3800002
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Guangzhou, Китай, 510080
- Investigational Site Number : 1560002
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Shanghai, Китай, 200120
- Investigational Site Number : 1560032
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Texas
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Southlake, Texas, Соединенные Штаты, 76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400005
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Olomouc, Чехия, 779 00
- Investigational Site Number : 2030001
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Чили, 8331143
- Investigational Site Number : 1520010
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Santiago, Reg Metropolitana de Santiago, Чили, 7500010
- Investigational Site Number : 1520016
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Santiago, Reg Metropolitana de Santiago, Чили, 8380456
- Investigational Site Number : 1520012
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
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Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively:
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Participants with CD
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who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study;
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who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study.
OR
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Participants with UC
- who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study;
- who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
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Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding
Exclusion Criteria:
- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
- Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
- Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.
- Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: CD cohort: balinatunfib dose regimen 1
Participants will receive balinatunfib dose regimen 1 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Экспериментальный: CD cohort: balinatunfib dose regimen 2
Participants will receive balinatunfib dose regimen 2 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Экспериментальный: CD cohort: balinatunfib dose regimen 3
Participants will receive balinatunfib dose regimen 3 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Плацебо Компаратор: CD cohort: Placebo
Participants will receive balinatunfib-matching placebo |
Pharmaceutical form:Tablet -Route of administration:Oral |
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Экспериментальный: UC cohort: balinatunfib dose regimen 1
Participants will receive balinatunfib dose regimen 1 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Экспериментальный: UC cohort: balinatunfib dose regimen 2
Participants will receive balinatunfib dose regimen 2 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Экспериментальный: UC cohort: balinatunfib dose regimen 3
Participants will receive balinatunfib dose regimen 3 |
Pharmaceutical form:Tablet -Route of administration:Oral
Другие имена:
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Плацебо Компаратор: UC cohort: Placebo
Participants will receive balinatunfib-matching placebo |
Pharmaceutical form:Tablet -Route of administration:Oral |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Количество участников с болезнью Крона с нежелательными явлениями, возникшими на фоне лечения (НЯЛ), серьезными нежелательными явлениями (СНЯ) и нежелательными явлениями, представляющими особый интерес (НЯОИ)
Временное ограничение: До конца исследования (приблизительно 106 недель)
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До конца исследования (приблизительно 106 недель)
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Количество участников с язвенным колитом с нежелательными явлениями, возникшими на фоне лечения (TEAEs), серьезными нежелательными явлениями (SAEs) и нежелательными явлениями, представляющими особый интерес (AESIs)
Временное ограничение: До окончания исследования (приблизительно 106 недель)
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До окончания исследования (приблизительно 106 недель)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Временное ограничение: Week 52
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Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. |
Week 52
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Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
Временное ограничение: Week 104
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Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. |
Week 104
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Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Временное ограничение: Week 52
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Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease. |
Week 52
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Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
Временное ограничение: Week 104
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Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease. |
Week 104
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Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Временное ограничение: Week 52
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Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity |
Week 52
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Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
Временное ограничение: Week 104
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Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity |
Week 104
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- LTS19689
- 2025-522511-42 (Идентификатор реестра: CTIS)
- U1111-1321-1765 (Идентификатор реестра: WHO ICTRP)
- 2025 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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