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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Zasocitinib

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400013
      • Recruiting
      • Chongqing General Hospital
      • Contact: Site Contact; Phone Number: 8613508389768; Email: 542162214@qq.com
      • Principal Investigator: Hong Guo
  • Guangdong
    • Guangdong, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Principal Investigator: Baili Chen
      • Contact: Site Contact; Phone Number: 0086-13302298302; Email: Chenbaili05@163.com
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-Sen University
      • Principal Investigator: Xiang Gao
      • Contact: Site Contact; Phone Number: 0086-13502405878; Email: helen_gao818@163.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 2000127
      • Recruiting
      • Renji Hospital Shanghai Jiaotong University School of Medicine
      • Principal Investigator: Zhi-jun Cao
      • Contact: Site Contact; Phone Number: 0086-13641788722; Email: caozj_renji@163.com
• Czechia
  • Hradec Králové, Czechia, 500 12
    • Recruiting
    • Hepato-Gastroenterologie HK s.r.o.
    • Principal Investigator: Tomas Vanasek
    • Contact: Site Contact; Phone Number: 420603545009; Email: tomas.vanasek@hepato-gastro.com
• Hungary
  • Budapest, Hungary, 1136
    • Recruiting
    • Pannonia Maganorvosi Centrum
    • Principal Investigator: Robert Schnabel
    • Contact: Site Contact; Phone Number: 36304202991; Email: schnabelrobert@hotmail.com
• Netherlands
  • North Brabant
    • Tilburg, North Brabant, Netherlands, 5022GC
      • Recruiting
      • St. Antonius Ziekenhuis
      • Principal Investigator: Robert Laheij
      • Contact: Site Contact; Phone Number: 0031(0)132218466; Email: r.laheij@elisabeth.nl
• Poland
  • Lublin, Poland, 35-326
    • Recruiting
    • Centrum Medyczne MedykSp. z o.o. Sp. K.
    • Principal Investigator: Rafal Filip
    • Contact: Site Contact; Phone Number: 48 509 130 097; Email: r.s.filip@wp.pl
  • Szczecin, Poland, 71-434
    • Recruiting
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
    • Contact: Site Contact; Phone Number: 48664929399; Email: gawdis@twojaprzychodnia.com
    • Principal Investigator: Beata Gawdis Wojnarska
  • Warsaw, Poland, 04-730
    • Recruiting
    • WIP Warsaw IBD Point Profesor Kierkus
    • Principal Investigator: Jaroslaw Kierkus
    • Contact: Site Contact; Phone Number: 48 500 111 648; Email: j.kierkus@med-net.pl; j.kierkus@czd.pl
  • Kuyavian-Pomeranian Voivodeship
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • Recruiting
      • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
      • Principal Investigator: Adam Kopon
      • Contact: Site Contact; Phone Number: 48 501 028 551; Email: adamkopon@interia.pl
• Slovakia
  • Košice, Slovakia, 4013
    • Recruiting
    • Endomed
    • Principal Investigator: Miroslav Fedurco
    • Contact: Site Contact; Email: fedurco@endomed.sk
• South Korea
  • Busan Gwangyeogsi
    • Haeundae, Busan Gwangyeogsi, South Korea, 48108
      • Recruiting
      • Inje University Haeundae Paik Hospital
      • Principal Investigator: Tae-Oh Kim
      • Contact: Site Contact; Phone Number: 0 93330 2333; Email: kto0440@paik.ac.kr
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 220-701
      • Recruiting
      • Yonsei University Wonju Severance Christian Hospital
      • Principal Investigator: Hyun-Soo Kim
      • Contact: Site Contact; Phone Number: 82337410505; Email: hyskim@yonsei.ac.kr
• United States
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Recruiting
      • Woodholme Gastroenterology Associates
      • Principal Investigator: Kenolisa Onwueme
      • Contact: Site Contact; Phone Number: 410-863-4899; Email: konwueme@woodholmegi.com
  • Texas
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Tyler Research Institute, LLC
      • Principal Investigator: George Aaron DuVall
      • Contact: Site Contact; Phone Number: 903-630-6211; Email: aarond@tylerri.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Zasocitinib; Participants with CD who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.	Drug: Zasocitinib; Zasocitinib capsules.; Other Names: TAK-279
Experimental: Cohort 2: Zasocitinib; Participants with UC who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.	Drug: Zasocitinib; Zasocitinib capsules.; Other Names: TAK-279
Experimental: Cohort 3: Zasocitinib; Participants with CD who completed Week 12 of the parent study, TAK-279-CD-2003 (NCT07403968) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.	Drug: Zasocitinib; Zasocitinib capsules.; Other Names: TAK-279

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)	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.	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	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.	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	Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.	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	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.	At Day 1 and Week 156 (current study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI)	Clinical remission is defined as a CDAI score of less than (<) 150 points.	Up to Week 156 (current study)
Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI	Clinical response is defined as greater than (>) 100-point decrease from parent study baseline in CDAI score.	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)	Endoscopic response is defined by decrease in SES-CD >50 percent (%) from baseline (defined as % baseline in parent study TAK-279-CD-2001 [NCT06233461]) (or for participants with isolated ileal disease, SES-CD less than or equal to (=<) 4 or at least a 2-point reduction from baseline). The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (intestinal surface affected by ulcers, intestinal surface affected by other inflammatory lesions, presence of ulcers, and presence of narrowing).	At Weeks 48, 108, and 156 (current study)
Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD	Endoscopic remission is defined as SES-CD score =< 4 or =< 2 for ileal disease, no sub-score >1. The SES-CD score ranges from 0 to 56 which includes 4 endoscopic variables (the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing).	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)	Clinical remission based on PRO2 is defined as average daily liquid or very soft stool frequency (SF) score less than or equal to (<=) 2.8 and not worse than parent study baseline and average daily abdominal pain (AP) score <=1 and not worse than baseline.	Up to Week 156 (current study)
Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2	Clinical response based on PRO2 is defined as greater than or equal to (>=) 30% decrease in average daily very soft or liquid stools and/ or >=30% decrease in average AP from parent study baseline.	Up to Week 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS)	The mMS is a composite score of 3 assessments consisting of stool frequency (SF), rectal bleeding (RB), and endoscopic score (ES). Each component sub-score ranges from 0 to 3 and total score range of the mMS is from 0 to 9, with higher scores indicating more severe disease. Clinical remission is defined as Mayo RB sub-score of 0, Mayo SF sub-score of 0 or 1, and ES sub-score 1 or 0 (score of 1 modified to exclude friability).	At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS	Clinical response is defined as reduction from parent study baseline in mMS of >=2 points and >=30% from parent study baseline and a decrease from parent study baseline in the RB sub-score of >=1 point or an absolute RB sub-score of <=1 point.	At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission	Symptomatic remission is defined as RB sub-score of 0 and SF sub-score of Mayo score <=1.	Up to Week 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES)	Endoscopic improvement is defined as a modified Mayo ES of <=1 (score of 1 modified to exclude friability).	At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES)	Endoscopic remission is defined as a modified Mayo ES of 0.	At Weeks 48, 108, and 156 (current study)
Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency	Bowel urgency is measured by the bowel urgency electronic diary (eDiary) item.	Up to Week 156 (current study)
Cohorts 1 and 2: Percentage of UC or CD Participants With no Abdominal Pain	Abdominal pain is measured by abdominal pain eDiary item.	Up to Week 156 (current study)
Cohorts 1 and 2: Change From Baseline in Fatigue in UC or CD Participants as Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score	The FACIT-Fatigue is a reliable and valid instrument for measuring fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 5-point Likert scale, where 0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit and 4=Very much. The total score ranges from 0 to 52. High scores represent less fatigue.	Up to Week 156 (current study)
Cohorts 1 and 2: Percentage of UC or CD Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score >=170	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional function (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Up to Week 156 (current study)
Cohorts 1 and 2: Change From Baseline in Disease-Specific Health-related Quality of Life (HRQoL) in UC or CD Participants as Measured by IBDQ Total Score	The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel systems (10 items), emotional functional (12 items), systemic function (5 items), and social function (5 items). The total score ranges from 32 to 224, with higher scores representing better quality of life.	Up to Week 156 (current study)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: TAK-279-IBD-2001; 2024-518914-18-00 (Ctis: EU CTR Number); jRCT2041250166 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No