Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

Официальное название

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

Обзор

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Вмешательства

• Препарат Tulisokibart
  Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
• Препарат Placebo to tulisokibart
  Placebo matching SC tulisokibart

Первичные конечные точки

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 378 weeks]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 364 weeks]

Вторичные конечные точки (4)

• Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) Score [Срок оценки: Week 364]
• Percentage of Participants with Crohn's Disease Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score [Срок оценки: Week 364]
• Percentage of Participants with Crohn's Disease With Endoscopic Remission Per Simplified Endoscopic Score for Crohn's Disease (SES-CD) [Срок оценки: Week 364]
• Percentage of Participants with Ulcerative Colitis Achieving Clinical Remission Per Modified Mayo Score (MMS) [Срок оценки: Week 364]

Критерии участия

Критерии включения

• Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
• The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
• A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
• A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
• A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Критерии исключения

• Has prematurely discontinued study intervention in their parent study
• Has received any protocol-specified prohibited medications during their parent study
• Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 14 центров

• Rivermed Sp. z.o.o. ( Site 2206) — Poznan
• Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208) — Włocławek
• Krakowskie Centrum Medyczne ( Site 2210) — Krakow
• Centrum Medyczne Oporow ( Site 2212) — Wroclaw
• Melita Medical Sp. z o.o. ( Site 2204) — Wroclaw
• Przychodnia Futuremeds Wroclaw ( Site 2211) — Wroclaw
• 1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205) — Lublin
• Medrise Sp. z o.o. ( Site 2200) — Lublin
• … и ещё 6 центров

США · 12 центров

• Connecticut Clinical Research Institute ( Site 0297) — Bristol
• St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287) — Ypsilanti
• BVL Research - Kansas ( Site 0292) — Liberty
• New York Gastroenterology Associates ( Site 0253) — New York
• GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290) — Garland
• GI Alliance - Lubbock ( Site 0288) — Lubbock
• Caprock Gastro Research ( Site 0293) — Lubbock
• Southern Star Research Institute ( Site 0299) — San Antonio
• … и ещё 4 центра

Франция · 4 центра

• Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002) — Nice
• CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003) — Neuilly-sur-Seine
• CHRU De Nancy - Hopital de Brabois ( Site 1001) — Vandœuvre-lès-Nancy
• Hopital Claude Huriez CHRU LILLE ( Site 1004) — Lille

Чехия · 2 центра

• Vojenská Nemocnice Brno-Internal department ( Site 0701) — Brno
• Hepato-Gastroenterologie HK ( Site 0700) — Hradec Králové

Венгрия · 2 центра

• Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( — Békéscsaba
• Semmelweis Egyetem ( Site 1400) — Budapest

Великобритания · 2 центра

• Whipps Cross University Hospital ( Site 3400) — London
• MAC Research - Merseyside ( Site 3401) — Prescot

Грузия · 1 центр

• ARENSIA Exploratory Medicine Georgia ( Site 1104) — Tbilisi

Идентификаторы

NCT: NCT06651281 · 7240-011 · 2024-513533-20-00 · U1111-1306-6970

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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