Идёт набор NCT07463183
A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: MK-8690, Placebo.
- Кому может быть актуально
- Состояния в реестре: Colitis Ulcerative, Ulcerative Colitis. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Греция, Нидерланды, Польша, South Korea +1
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis
Обзор
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Вмешательства
- Препарат MK-8690
Solution for subcutaneous injection - Другое Placebo
Solution for subcutaneous injection
Первичные конечные точки
- Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 [Срок оценки: Week 12]
Вторичные конечные точки (6)
- Percentage of Participants With One or More Adverse Events (AEs) [Срок оценки: Up to approximately 12 months]
- Percentage of Participants Who Discontinued Study Intervention Due to an AE [Срок оценки: Up to approximately 12 months]
- Percentage of Participants Achieving Clinical Response Per MMS at Week 12 [Срок оценки: Week 12]
- Percentage of Participants With Endoscopic Improvement at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12 [Срок оценки: Week 12]
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12 [Срок оценки: Week 12]
Критерии участия
The main inclusion criteria include but are not limited to the following:
- Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
- Has moderately to severely active UC
- Has a weight ≥40 kg
- Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
- Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- Has a current diagnosis of fulminant colitis and/or toxic megacolon
- Has UC limited to the rectum
- Has a current or impending need for colostomy or ileostomy
- Has had a total proctocolectomy or partial colectomy
- Has UC exacerbation requiring hospitalization within 2 weeks before Screening
- Has any active infection as specified in the protocol
- Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
- Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
- Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
- Has received protocol-specified prohibited medications
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 9 центров
- Clinnova Research ( Site 1042) — Anaheim
- Peak Gastroenterology Associates ( Site 1052) — Colorado Springs
- South Denver Gastroenterology, PC ( Site 1068) — Englewood
- Nature Coast Clinical Research ( Site 1045) — Inverness
- Research Associates of South Florida - Miami - Southwest 8th Street ( Site 1072) — Miami
- Gastroenterology Associates of Central Georgia ( Site 1060) — Macon
- University of Kansas Medical Center ( Site 1077) — Kansas City
- Tulane University School of Medicine ( Site 1073) — New Orleans
- … и ещё 1 центр
South Korea · 3 центра
- Wonju Severance Christian Hospital ( Site 1602) — Wŏnju
- Korea University Ansan Hospital ( Site 1603) — Ansan-si
- Kangbuk Samsung Hospital ( Site 1601) — Seoul
Польша · 2 центра
- EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 1449) — Warsaw
- Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś ( Site 1448) — Warsaw
Греция · 1 центр
- Evangelismos General Hospital of Athens ( Site 1362) — Athens
Нидерланды · 1 центр
- Radboudumc ( Site 1650) — Nijmegen
Великобритания · 1 центр
- Huddersfield Royal Infirmary ( Site 1522) — Huddersfield
Идентификаторы
NCT: NCT07463183 · 8690-002 · MK-8690-002 · U1111-1326-7763 · 2025-523479-49-00