A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

Официальное название

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Обзор

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 3 years (156 weeks). During the study, participants will visit their study clinic around 15 times.

Вмешательства

• Препарат Zasocitinib
  Zasocitinib capsules.

Первичные конечные точки

• All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) [Срок оценки: From start of study drug administration up to Week 160 (current study)]
• All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values [Срок оценки: From start of study drug administration up to Week 160 (current study)]
• All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values [Срок оценки: From start of study drug administration up to Week 160 (current study)]
• Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values [Срок оценки: At Day 1 and Week 156 (current study)]

Вторичные конечные точки (12)

• Cohort 1: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) [Срок оценки: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI [Срок оценки: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohort 1: Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2) [Срок оценки: Up to Week 156 (current study)]
• Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2 [Срок оценки: Up to Week 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS) [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission [Срок оценки: Up to Week 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES) [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES) [Срок оценки: At Weeks 48, 108, and 156 (current study)]
• Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency [Срок оценки: Up to Week 156 (current study)]

Критерии участия

Критерии включения

• The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.

The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures.

• Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001).
• Clinical or symptomatic responder at parent trial Week 52 as defined below:

• TAK-279-CD-2001: Clinical response at Week 52 of the parent trial based on PRO2, assessed as >=30% decrease in average daily very soft or liquid stools and/ or >=30% decrease in average AP from parent trial baseline.
• TAK-279-UC-2001: Symptomatic response at Week 52 of the parent trial, assessed as a reduction in partial modified Mayo score (pmMS) of >=1 points and >=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of >=1 point or an absolute rectal bleeding sub-score of <=1 point.
• TAK-279-CD-2003: Endoscopic response at Week 12 of the parent trial, assessed as a participant achieving decrease in SES-CD >50% from baseline (or for participants with isolated ileal disease, SES-CD <=4 or at least a 2-point reduction from baseline).

Other General Inclusion Criteria:

• Participants must meet the contraception recommendations.

Критерии исключения

• Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
• Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.

Exclusion Criteria related to Laboratory Investigations:

• Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.

Exclusion criteria related to other prohibited concomitant medication for TAK-279-CD-2001 and TAK-279-UC-2001 Cohorts:

• Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

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

Китай · 4 центра

• Chongqing General Hospital — Чунцин
• The First Affiliated Hospital of Sun Yat-sen University — Guangdong
• The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Renji Hospital Shanghai Jiaotong University School of Medicine — Шанхай

Польша · 4 центра

• Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskop — Torun
• Centrum Medyczne MedykSp. z o.o. Sp. K. — Lublin
• Twoja Przychodnia - Szczecinskie Centrum Medyczne — Szczecin
• WIP Warsaw IBD Point Profesor Kierkus — Warsaw

США · 2 центра

• Woodholme Gastroenterology Associates — Glen Burnie
• Tyler Research Institute, LLC — Tyler

South Korea · 2 центра

• Inje University Haeundae Paik Hospital — Haeundae
• Yonsei University Wonju Severance Christian Hospital — Wŏnju

Чехия · 1 центр

• Hepato-Gastroenterologie HK s.r.o. — Hradec Králové

Венгрия · 1 центр

• Pannonia Maganorvosi Centrum — Budapest

Нидерланды · 1 центр

• St. Antonius Ziekenhuis — Tilburg

Словакия · 1 центр

• Endomed — Košice

Идентификаторы

NCT: NCT06764615 · TAK-279-IBD-2001 · 2024-518914-18-00 · jRCT2041250166

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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