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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 28
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
时间窗: From start of study drug administration up to Week 112 (current study)
TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
Number of Participants With Clinically Significant Changes in Vital Sign Values
时间窗: From start of study drug administration up to Week 112 (current study)
Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
时间窗: From start of study drug administration up to Week 112 (current study)
Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values
时间窗: At Day 1 and Week 108 (current study)
ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion.
次要结局
- Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI)(Up to Week 108 (current study))
- Percentage of CD Participants Achieving Clinical Response Based on the CDAI(Up to Week 108 (current study))
- Percentage of CD Participants Achieving Decrease in Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD)(At Weeks 48 and 108 (current study))
- Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD(At Weeks 48 and 108 (current study))
- Percentage of CD Participants With Clinical Remission in 2-item Patient-reported Outcome Measure (PRO2)(Up to Week 108 (current study))
- Percentage of CD Participants With a Clinical Response in PRO2(Up to Week 108 (current study))
- Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS)(At Weeks 48 and 108 (current study))
- Percentage of UC Participants Achieving Clinical Response Based on mMS(At Weeks 48 and 108 (current study))
- Percentage of UC Participants Achieving a Symptomatic Remission(Up to Week 108 (current study))
- Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES)(At Weeks 48 and 108 (current study))
- Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES)(At Weeks 48 and 108 (current study))
- Percentage of CD or UC Participants With no Bowel Urgency(Up to Week 108 (current study))
- Percentage of UC or CD Participants With no Abdominal Pain(Up to Week 108 (current study))
- Change From Baseline in Fatigue in UC or CD Participants as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score(Up to Week 108 (current study))
- Percentage of UC or CD Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170(Up to Week 108 (current study))
- Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) in UC or CD Participants as Measured by IBDQ Total Score(Up to Week 108 (current study))