Crohn's Disease · Ulcerative Colitis
Long-term oral zasocitinib study for adults with Crohn’s disease or ulcerative colitis
This Phase 2 extension study is examining the long-term safety, tolerability, and disease effects of oral zasocitinib in adults with moderately to severely active Crohn’s disease or ulcerative colitis who met response requirements in specified parent studies.
Registry title: A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Zasocitinib
- Design
- Not provided
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
Over long-term use, what safety and tolerability findings occur with zasocitinib, and how do bowel inflammation and symptoms change in these adults with Crohn’s disease or ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75 with Crohn’s disease or ulcerative colitis.
- The study is looking for participants who completed the required period of one of three specified parent studies.
- Participants must have met the clinical, symptomatic, or endoscopic response requirement specified for their parent-study cohort.
- Participants must be able and willing to follow study procedures, including use of digital tools and applications.
Participation overview
What participation may involve
Participants continue from a specified parent study into one of three extension cohorts and take oral zasocitinib while the study monitors safety, symptoms, disease activity, and quality of life. What participation may involve: - Take zasocitinib capsules by mouth. - Attend study-clinic visits for safety monitoring, including adverse-event review, vital signs, and laboratory testing. - Complete disease-symptom, fatigue, and quality-of-life assessments, including electronic diary items. - Cohorts 1 and 2 undergo endoscopic disease assessments at Weeks 48, 108, and 156; these assessments are not reported for Cohort 3. The registry states that participants may receive zasocitinib for up to 3 years, or 156 weeks. The registry says participants will visit the study clinic around 15 times.
Study interventions
What participants may receive or do
- Zasocitinib: Participants in all three cohorts receive zasocitinib, also called TAK-279, as oral capsules for up to 156 weeks.
Study design
How the comparison works
This is a Phase 2, open-label extension study with one intervention group. Participants enter one of three cohorts based on their disease and parent study, and every cohort receives oral zasocitinib. The registry lists allocation as not applicable and uses a single-group design, so it does not describe random assignment between treatments. The study is open-label with no masking, meaning the assigned study treatment is not blinded. The registry describes no separate control or comparator group; all three cohorts receive zasocitinib. The registry describes no placebo arm; all listed cohorts receive zasocitinib.
Reported activities
Procedures and tests
- Monitoring and reporting of treatment-emergent adverse events and adverse events of special interest.
- Vital-sign measurements, including temperature, breathing rate, seated blood pressure, and pulse.
- Clinical laboratory testing involving hematology, blood chemistry, and urinalysis.
- For Cohorts 1 and 2, a 12-lead electrocardiogram after at least five minutes of rest at Day 1 and Week 156.
- For Cohort 1, Crohn’s Disease Activity Index and two-item patient-reported outcome assessments of stool frequency and abdominal pain.
- For Cohort 1, endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease at Weeks 48, 108, and 156.
- For Cohort 2, modified Mayo assessments of stool frequency, rectal bleeding, and endoscopic findings.
- Electronic diary entries about bowel urgency and abdominal pain for Cohorts 1 and 2.
- A 13-item Functional Assessment of Chronic Illness Therapy–Fatigue questionnaire for Cohorts 1 and 2.
- A 32-item Inflammatory Bowel Disease Questionnaire covering bowel symptoms, emotional function, systemic function, and social function for Cohorts 1 and 2.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 75 years old.
- Participants must be willing and able to understand and follow all study procedures and requirements, including digital tools and applications, as judged by the investigator.
- For the TAK-279-CD-2001 and TAK-279-UC-2001 cohorts, participants must have completed Week 52 of the parent study and have valid electronic diary data for that week.
- For TAK-279-CD-2001, participants must have had a Week 52 clinical response based on the specified improvement in stool frequency and/or abdominal pain.
- For TAK-279-UC-2001, participants must have had the specified Week 52 symptomatic response based on partial modified Mayo score and rectal bleeding.
- For TAK-279-CD-2003, participants must have had the specified endoscopic response at Week 12, with a separate threshold for isolated ileal disease.
- Participants must meet the study’s contraception recommendations.
Possible reasons someone may not be able to join
- The investigator may exclude someone because of concerns about study compliance or medication adherence.
- Participants are excluded if malignancy or dysplasia was found by endoscopy at any time during the parent study or at the start of this extension study.
- Participants are excluded if they meet laboratory-related exclusion rules defined in the protocol; the registry does not list those rules.
- For the TAK-279-CD-2001 and TAK-279-UC-2001 cohorts, participants are excluded if they took oral corticosteroids for Crohn’s disease or ulcerative colitis at or after Week 48 of the parent study.
Important unknowns
What the record does not make clear
- The registry reports around 15 clinic visits but does not provide the timing or expected length of each visit.
- The registry identifies one corticosteroid restriction but does not explain which other Crohn’s disease or ulcerative colitis treatments may continue during the extension.
- The registry gives a timing restriction for oral corticosteroids in two cohorts but does not provide a complete list of medication washout requirements.
- The registry does not state what rescue treatment is available if disease symptoms worsen.
- Endoscopic outcomes are scheduled for Cohorts 1 and 2, and dysplasia or malignancy at the beginning of the extension is exclusionary, but the registry does not fully describe entry endoscopy requirements or endoscopy requirements for Cohort 3.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether transportation, lodging, parking, or other travel support is available.
- The registry reports clinic visits but does not say whether any visits or assessments can be completed remotely.
- The registry does not state whether zasocitinib may remain available after participation ends.
- The study and listed sites are marked recruiting, but the registry does not show which disease and parent-study cohorts are open at each site.
- The registry identifies zasocitinib capsules but does not report the dose or dosing frequency.
Before contacting the site
Questions for the study team
- Is the cohort connected to my disease and parent study currently enrolling at the site I would attend?
- What dose of zasocitinib would I take, how often would I take it, and what should I do after a missed dose?
- What is the timing and expected length of the approximately 15 clinic visits?
- Which endoscopies are required for my cohort, and will sedation or preparation be involved?
- Which current medicines may continue, which must stop, and are any washout periods required?
- What happens if my Crohn’s disease or ulcerative colitis worsens during the study?
- Which costs are covered, and are compensation or travel support available?
- What options are available after the 156-week treatment period if I am still taking zasocitinib?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease or ulcerative colitis now, and what changes would make long-term extension-study participation medically concerning?
- How could the study’s medication restrictions affect my current treatment plan, especially any oral corticosteroid use?
- What approved treatment alternatives should I understand before considering continued zasocitinib in this study?
- Are the planned laboratory tests, electrocardiograms, and endoscopies appropriate given my health history and prior results?
- How should you and the research team coordinate routine care, test results, symptom changes, and treatment decisions during the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- TAK-279-IBD-2001
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
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.
Interventions: Drug: Zasocitinib
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.
Interventions: Drug: Zasocitinib
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.
Interventions: Drug: Zasocitinib
Interventions
Drug
Zasocitinib
Zasocitinib capsules.
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (8)
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Clinical or symptomatic responder at parent trial Week 52 as defined below:Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Participants must meet the contraception recommendations.Registry-derived · unreviewed
Exclusion criteria (3)
- Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.Registry-derived · unreviewed
- Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.Registry-derived · unreviewed
- Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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.
Primary outcome
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.
Primary outcome
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.
Primary outcome
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.
Secondary outcome
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)
Clinical remission is defined as a CDAI score of less than (\<) 150 points.
Secondary outcome
Cohort 1: Percentage of CD Participants Achieving Clinical Response Based on the CDAI
Time frame: Up to Week 156 (current study)
Clinical response is defined as greater than (\>) 100-point decrease from parent study baseline in CDAI score.
Secondary outcome
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)
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).
Secondary outcome
Cohort 1: Percentage of CD Participants Achieving Endoscopic Remission Based on SES-CD
Time frame: At Weeks 48, 108, and 156 (current study)
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).
Secondary outcome
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)
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.
Secondary outcome
Cohort 1: Percentage of CD Participants With a Clinical Response in PRO2
Time frame: Up to Week 156 (current study)
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.
Secondary outcome
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)
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).
Secondary outcome
Cohort 2: Percentage of UC Participants Achieving Clinical Response Based on mMS
Time frame: At Weeks 48, 108, and 156 (current study)
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.
Secondary outcome
Cohort 2: Percentage of UC Participants Achieving a Symptomatic Remission
Time frame: Up to Week 156 (current study)
Symptomatic remission is defined as RB sub-score of 0 and SF sub-score of Mayo score \<=1.
Secondary outcome
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)
Endoscopic improvement is defined as a modified Mayo ES of \<=1 (score of 1 modified to exclude friability).
Secondary outcome
Cohort 2: Percentage of UC Participants Achieving Endoscopic Remission Based on Modified Mayo (ES)
Time frame: At Weeks 48, 108, and 156 (current study)
Endoscopic remission is defined as a modified Mayo ES of 0.
Secondary outcome
Cohorts 1 and 2: Percentage of CD or UC Participants With no Bowel Urgency
Time frame: Up to Week 156 (current study)
Bowel urgency is measured by the bowel urgency electronic diary (eDiary) item.
Secondary outcome
Cohorts 1 and 2: Percentage of UC or CD Participants With no Abdominal Pain
Time frame: Up to Week 156 (current study)
Abdominal pain is measured by abdominal pain eDiary item.
Secondary outcome
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)
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.
Secondary outcome
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)
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.
Secondary outcome
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)
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.
Recruiting locations in the United States
Woodholme Gastroenterology Associates
RecruitingGlen Burnie, Maryland, 21061, United States
Site Contact410-863-4899konwueme@woodholmegi.com
Kenolisa Onwueme
Tyler Research Institute, LLC
RecruitingTyler, Texas, 75701, United States
Site Contact903-630-6211aarond@tylerri.com
George Aaron DuVall
This study also lists 14 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Jan 8, 2025
- Primary completion
- Dec 30, 2029
- Overall completion
- Dec 30, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.