A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease

Официальное название

An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease

Обзор

Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is. The participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy. During the study, participants will visit the study clinic several times.

Подробное описание

Zasocitinib will be tested in this mechanistic study in adult participants with active Crohn's disease (CD). Peripheral blood and affected intestinal biopsy samples will be evaluated at the cellular and molecular levels, before and during zasocitinib treatment. The study will assess therapeutic biology, biomarkers, and the safety of zasocitinib.

The study will enroll approximately 20 participants. This is a single center study. The overall duration is up to approximately 5 months (20 weeks) including a 4-week safety follow-up period.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib administered orally.

Первичные конечные точки

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs) [Срок оценки: From start of study drug administration up to follow-up (up to Week 16)]

Критерии участия

Критерии включения

• Men and women aged 18 to 75 years can participate in the study.
• Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.
• Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.

Критерии исключения

• Cannot have another condition that causes swelling (inflammation) in the bowel.
• Cannot have complications of CD which may require surgery.
• Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.
• Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.
• Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.
• Cannot have or had a J-pouch.
• Cannot have had infections up to 2 months (8 weeks) before study start.
• Cannot have given blood or plasma within 1 month (30 days) before study start.
• Cannot tolerate having blood taken with a needle from a vein (venipuncture).

Additional entry criteria will be discussed with the study doctor.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07403968 · TAK-279-CD-2003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗