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

NCT06764615 · tracked via the Priya Life Science China tracker

Sponsor

Takeda

Phase

Phase 2

Started

2025-05-28

Last updated

2026-05-22

Condition(s) studied

Crohn's DiseaseUlcerative Colitis

Investigational drug(s) / intervention(s)

Zasocitinib

Zasocitinib: Zasocitinib capsules.

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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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 China

A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease Recruiting

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) Recruiting

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia Active, not recruiting

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) Recruiting

Other trials for the same condition

Effect of Incentive Integrated E-IBD Chronic Disease Management Model on the Quality of Life in IBD Patients Starting soon

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. Active, not recruiting

A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease Recruiting

A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting

Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis Recruiting

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 China