A Phase 2 interventional study of Zasocitinib in Crohn's Disease and Ulcerative Colitis, sponsored by Takeda. Recruiting at 16 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Takeda · Phase 2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 192 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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).
Other General Inclusion Criteria:
Exclusion Criteria:
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:
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 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
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
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.
Also known as: TAK-279
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 1 and Week 156 (current study)
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.
Time frame: 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.
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)
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).
Time frame: 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).
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)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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)
Endoscopic improvement is defined as a modified Mayo ES of \<=1 (score of 1 modified to exclude friability).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: Up to Week 156 (current study)
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
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