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A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn’s Disease (CD)
EU CTIS ID: 2024-518914-18-00
What this study is testing
Crohn’s Disease (CD) or Ulcerative Colitis (UC): To assess the long-term safety and tolerability of oral zasocitinib in participants with moderately to severely active CD or UC who meet response criteria at Week 52 in the parent phase 2 CD or UC trials (TAK‑279-CD-2001 and TAK-279-UC-2001, respectively), and receive long-term treatment of zasocitinib for up to 108 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 phase 2 CD and UC trials with valid eDiary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001). If eDiary data is not available at Week 52, prior scores may be used upon consultation with the medical monitor.
- 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: a) TAK-279-CD-2001: Clinical response in PRO2 at parent trial Week 52, assessed as ≥30% decrease in average daily very soft or liquid stools and/or ≥decrease in average AP from parent trial baseline. b) TAK-279-UC-2001: Symptomatic response at parent trial Week 52, assessed as a reduction in pmMS of ≥1 points and ≥30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point.
- 4. Participants are nonpregnant, nonlactating or of nonchildbearing potential. For individuals of reproductive potential, if sexually active, agree to comply with the contraceptive requirements for the duration of the trial and 10 days after the last dose of the trial intervention. The following birth control requirements must be met: a) Effective contraception for male (sex-assigned at birth) participants (male condom) is required from the signing of informed consent throughout the duration of the trial and for 10 days after the last dose of the trial intervention. b) Female (sex-assigned at birth) participants must be surgically sterile or be of nonchildbearing potential with confirmation of postmenopausal status (ie, follicle-stimulating hormone [FSH] level >40 mIU/mL); or, if sexually active with a nonsterilized individual who produces sperm agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the trial and for 10 days after the last dose.
You likely can't join if
- 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
- 3. Are pregnant, nursing, or planning pregnancy while in the OLE trial or within 10 days of the trial intervention after the last dose of the trial intervention.
- 4. Participant has inadequate renal or hepatic function before enrollment based on the following parameters: a) Total bilirubin (unconjugated and/or conjugated) ≥1.5 × upper limit normal (ULN) unless the participant has known Gilbert’s syndrome that can explain the elevation of bilirubin, or b) Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × ULN, or c) Creatinine >1.5 × ULN. d) Estimated creatinine clearance <45 mL/min based on the Cockcroft-Gault calculation. e) Participant with elevated lipase and/or amylase >3 × ULN. Participants with elevated lipase and/or amylase >2 × ULN will require further workup such as radiological imaging and physical examination to rule out a diagnosis of acute pancreatitis. Once a diagnosis of acute pancreatitis has been completely ruled out, then the participant can be included in the trial. f) Participants with a history of chronic pancreatitis or recent acute pancreatitis (<60 days/ not fully resolved).
- 5. Participant with any of the following laboratory values at or prior to enrollment: a) Hemoglobin <9.0 g/dL (<90.0 g/L) b) Absolute white blood cell count <3.0 × 109/L (<3000/mm3) c) Absolute neutrophil count of <1.2 × 109/L (<1200/mm3) d) Absolute lymphocyte count of <0.75 × 109/L (<750/mm3) e) Platelet count <100 × 109/L f) Triglyceride level ≥750 mg/dL (≥8.5 mmol/L) g) Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial. h) Creatine phosphokinase (CPK) > ULN. CPK may be repeated once; if repeat value is CTCAE Grade 1 or lower (or ≤2.5 × ULN) and no higher than the initial value, participant remains eligible. Investigators should assess the participant for modulating factors including concomitant medications or vigorous exercise that may affect CPK levels.
- 6. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- China
- Japan
- United States
- Switzerland
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; China; Japan; United States; Switzerland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.