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Study on the Effects of Zasocitinib for Patients with Moderate to Severe Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as ulcerative colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study is investigating a new treatment called Zasocitinib, also known by its code name TAK-279. This medication is taken orally in the form of a capsule. The trial will compare the effects of Zasocitinib with a placebo to determine its effectiveness and safety in treating people with moderately to severely active ulcerative colitis.

The purpose of the study is to evaluate whether Zasocitinib can help achieve clinical remission, which means reducing the symptoms of ulcerative colitis, by the 12th week of treatment. Participants in the study will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The trial will last for a total of 52 weeks, with the main focus on the first 12 weeks to assess the initial response to the treatment.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the effects of the treatment. These assessments will include evaluating symptoms such as stool frequency and rectal bleeding, as well as conducting endoscopic examinations to observe the condition of the colon. The study aims to provide valuable information on the potential benefits of Zasocitinib for individuals suffering from ulcerative colitis, with the hope of improving their quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the medication zasocitinib or a placebo. The placebo is a capsule that looks like the medication but does not contain the active substance.

    The study is designed to be double-blind, meaning neither the participant nor the researchers will know who is receiving the actual medication or the placebo.

  2. Step 2

    Medication administration

    The participant will take the assigned capsule orally. The exact dosage and frequency will be provided by the study team, and it is important to follow these instructions carefully.

    The medication or placebo will be taken for a period of 12 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the 12-week period, the participant will undergo regular assessments to monitor the effects of the medication. These assessments may include physical examinations, blood tests, and questionnaires about symptoms and quality of life.

    Participants will also be required to keep an electronic diary to record any bowel urgency and abdominal pain experienced during the study.

  4. Step 4

    End of treatment evaluation

    At the end of the 12-week treatment period, the participant will undergo a final evaluation to assess the effectiveness of the medication. This will include a colonoscopy to examine the condition of the colon.

    The primary goal is to determine if the participant has achieved clinical remission, which means a significant reduction in symptoms and inflammation.

  5. Step 5

    Follow-up

    After the treatment period, there may be additional follow-up visits to monitor the participant's health and any long-term effects of the medication.

    Participants will be informed about the results of the study and their individual outcomes once the study is completed.

Who can join the trial?

9 criteria

  • The person must be willing and able to understand and follow the study procedures and requirements. They must also provide written consent to participate in the study.
  • The person must be between 18 and 75 years old at the time of signing the consent form.
  • The person must have **moderately to severely active ulcerative colitis** at the time of screening. This is determined by a specific scoring system called the **modified Mayo score**, which should be between 5 to 9 points, and an **endoscopic subscore** of 2 or more. An endoscopic subscore is a part of the scoring system that looks at the inside of the colon using a camera.
  • The person must have a confirmed diagnosis of ulcerative colitis for at least 30 days before screening. This means they need to have had a test called an **endoscopy** with a **biopsy** (a small tissue sample) that shows they have ulcerative colitis. The disease should affect more than 15 cm from the anal verge, which is the opening of the anus.
  • If the person has had **extensive colitis** or **pancolitis** for more than 8 years, or **left-sided colitis** for more than 12 years, they must have had a **surveillance colonoscopy** within 12 months of the initial screening visit. A surveillance colonoscopy is a procedure to check the colon for any changes or problems.
  • If the person has a family history of colorectal cancer, a personal history of increased risk for colorectal cancer, is over 50 years old, or has other known risk factors, they must be up to date on colorectal cancer checks. This can be done during the screening.
  • The person must be willing and able to have a colonoscopy with biopsies during the screening after meeting all other inclusion criteria.
  • The person must have a history of not responding well, losing response, or not being able to tolerate one or more treatments for ulcerative colitis. This includes treatments like **6-mercaptopurine**, **azathioprine**, oral or IV **corticosteroids**, or **biologic agents**. Biologic agents are advanced treatments that target specific parts of the immune system.
  • The person must agree to follow the study's birth control requirements. Female participants who can have children and are sexually active must agree to use effective birth control during the study and for 10 days after the last dose of the study drug. Female participants who cannot have children must be surgically sterile or confirmed to be postmenopausal.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had recent surgery related to the digestive system.
  • Patients who are currently using certain medications that might affect the study results.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have a history of certain infections that could affect the study.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a condition called **immunodeficiency**, which means their immune system is not working properly.
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Investigated drugs

TAK-279 is an oral medication being studied for its effectiveness and safety in treating people with moderately to severely active ulcerative colitis. The trial aims to see if this medication can help achieve clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis, by the end of 12 weeks.

What is already known about the treatment

TAK-279 – TAK-279 is an oral medication currently being studied in clinical trials for its effectiveness in treating moderate to severely active ulcerative colitis. It is administered in pill form and is designed to be taken by mouth. The main goal of the ongoing research is to determine if TAK-279 can help patients achieve clinical remission of their symptoms. The medication works by targeting specific pathways in the immune system to reduce inflammation in the colon. TAK-279 is classified as an immunomodulatory agent, and its development is still in the experimental phase, with ongoing studies to confirm its safety and efficacy.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to more severe symptoms. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response. The condition can significantly impact a person's quality of life due to its persistent and unpredictable nature.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506769-67-00Protocol codeTAK-279-UC-2001Estimated enrolment276 patientsSponsorTakeda Development Center Americas Inc.

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