Clinical Trials in South Korea / NCT06764615
Recruiting
Phase 2
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
NCT06764615 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Crohn's DiseaseUlcerative Colitis
Study summary
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.
Eligibility
Inclusion Criteria:
1. 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.
2. 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).
3. Clinical or symptomatic responder at parent trial Week 52 as defined below:
1. 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.
2. 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.
4. 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:
5. Participants must meet the contraception recommendations.
Exclusion Criteria:
1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
2. 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:
3. 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:
4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
Primary outcome measure(s)
- All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) — From start of study drug administration up to Week 160 (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. - All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values — From start of study drug administration up to Week 160 (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. - All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values — From start of study drug administration up to Week 160 (current study)
Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion. - Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values — At Day 1 and Week 156 (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.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | Recruiting |
| Tyler Research Institute, LLC | Tyler | Texas | Recruiting |
| Chongqing General Hospital | Chongqing | Chongqing Municipality | Recruiting |
| The First Affiliated Hospital of Sun Yat-sen University | Guangdong | Guangdong | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | Recruiting |
| Renji Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | Recruiting |
| Hepato-Gastroenterologie HK s.r.o. | Hradec Králové | Czechia | Recruiting |
| Pannonia Maganorvosi Centrum | Budapest | Hungary | Recruiting |
| St. Antonius Ziekenhuis | Tilburg | North Brabant | Recruiting |
| Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj | Torun | Kuyavian-Pomeranian Voivodeship | Recruiting |
| Centrum Medyczne MedykSp. z o.o. Sp. K. | Lublin | Poland | Recruiting |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Recruiting |
| Endomed | Košice | Slovakia | Recruiting |
| Inje University Haeundae Paik Hospital | Haeundae | Busan Gwangyeogsi | Recruiting |
| Yonsei University Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | Recruiting |
More Takeda trials in South Korea
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06764615 on ClinicalTrials.gov ↗ ← All trials in South Korea