Crohn's DiseasePhase 2NCT06764615
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
A Phase 2 study testing Zasocitinib in people with Crohn's Disease and Ulcerative Colitis, run by Takeda at 16 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Zasocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 16 sitesin 8 countries
- Study dates
- 28 May 2025to 30 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
16 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 8 countries
China4 sites, 4 recruiting
- Recruiting
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400013
Site Contact, 8613508389768, 542162214@qq.com
Hong Guo
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, 510080
Site Contact, 0086-13302298302, Chenbaili05@163.com
Baili Chen
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Site Contact, 0086-13502405878, helen_gao818@163.com
Xiang Gao
- Recruiting
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 2000127
Site Contact, 0086-13641788722, caozj_renji@163.com
Zhi-jun Cao
Poland4 sites, 4 recruiting
- Recruiting
Centrum Medyczne MedykSp. z o.o. Sp. K.
Lublin, 35-326
Site Contact, 48 509 130 097, r.s.filip@wp.pl
Rafal Filip
- Recruiting
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
Site Contact, 48664929399, gawdis@twojaprzychodnia.com
Beata Gawdis Wojnarska
- Recruiting
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Site Contact, 48 501 028 551, adamkopon@interia.pl
Adam Kopon
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-730
Site Contact, 48 500 111 648, j.kierkus@med-net.pl; j.kierkus@czd.pl
Jaroslaw Kierkus
United States2 sites, 2 recruiting
- Recruiting
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061
Site Contact, 410-863-4899, konwueme@woodholmegi.com
Kenolisa Onwueme
- Recruiting
Tyler Research Institute, LLC
Tyler, Texas, 75701
Site Contact, 903-630-6211, aarond@tylerri.com
George Aaron DuVall
South Korea2 sites, 2 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Haeundae, Busan Gwangyeogsi, 48108
Site Contact, 0 93330 2333, kto0440@paik.ac.kr
Tae-Oh Kim
- Recruiting
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 220-701
Site Contact, 82337410505, hyskim@yonsei.ac.kr
Hyun-Soo Kim
Czechia1 site, 1 recruiting
- Recruiting
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, 500 12
Site Contact, 420603545009, tomas.vanasek@hepato-gastro.com
Tomas Vanasek
Hungary1 site, 1 recruiting
- Recruiting
Pannonia Maganorvosi Centrum
Budapest, 1136
Site Contact, 36304202991, schnabelrobert@hotmail.com
Robert Schnabel
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Ziekenhuis
Tilburg, North Brabant, 5022GC
Site Contact, 0031(0)132218466, r.laheij@elisabeth.nl
Robert Laheij
Slovakia1 site, 1 recruiting
- Recruiting
Endomed
Košice, 4013
Site Contact, fedurco@endomed.sk
Miroslav Fedurco
About this study
Official title: 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.
Read more
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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Zasocitinib
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZasocitinibDrug
Also called TAK-279
Zasocitinib capsules.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Zasocitinib | Experimental | 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. Receives: Drug: Zasocitinib |
| Cohort 2: Zasocitinib | Experimental | 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. Receives: Drug: Zasocitinib |
| Cohort 3: Zasocitinib | Experimental | 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. Receives: Drug: Zasocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 1 and Week 156 (current study)
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 156 (current study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start28 May 2025
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764615
- Sponsor's protocol ID
- TAK-279-IBD-2001
- Other IDs
- 2024-518914-18-00, jRCT2041250166
- Status last verified
- May 2026
- First submitted
- 2 Jan 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06764615
- Acronym / sponsor ID
- TAK-279-IBD-2001
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Zasocitinib | Experimental | Drug: ZasocitinibParticipants 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. |
| Cohort 2: Zasocitinib | Experimental | Drug: ZasocitinibParticipants 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. |
| Cohort 3: Zasocitinib | Experimental | Drug: ZasocitinibParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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-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).
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZasocitinibAlso: TAK-279Zasocitinib capsules. | Drug | Cohort 1: Zasocitinib, Cohort 2: Zasocitinib, Cohort 3: Zasocitinib |
Primary outcome
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
16 secondary outcomes
Cohort 1: Percentage of CD Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI)
Time frame: Up to Week 156 (current study)
Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI
Time frame: 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)
Time frame: At Weeks 48, 108, and 156 (current study)
Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD
Time frame: 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)
Time frame: Up to Week 156 (current study)
Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2
Time frame: Up to Week 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Clinical Remission Based on Modified Mayo Score (mMS)
Time frame: At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS
Time frame: At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission
Time frame: Up to Week 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Endoscopic Improvement Based on Modified Mayo Endoscopic Sub-score (ES)
Time frame: At Weeks 48, 108, and 156 (current study)
Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES)
Time frame: At Weeks 48, 108, and 156 (current study)
Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency
Time frame: Up to Week 156 (current study)
Cohorts 1 and 2: Percentage of UC or CD Participants With no Abdominal Pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Week 156 (current study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zasocitinib in people with Crohn's Disease and Ulcerative Colitis, run by Takeda at 16 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China, Poland, United States, South Korea, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) (time frame: From start of study drug administration up to Week 160 (current study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.