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Study on the Long-Term Effects of TEV-48574 (Duvakitug) for Adults with Moderate to Severe Ulcerative Colitis or Crohn's Disease

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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 the effects of a treatment called TEV-48574 for adults with moderate to severe Ulcerative Colitis or Crohn's Disease. These are chronic conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and fatigue. The treatment involves a solution for injection containing a substance known as duvakitug, which is administered under the skin every four weeks.

The purpose of the study is to evaluate how well TEV-48574 works over a long period, focusing on its ability to maintain remission in patients. Remission means that the symptoms of the disease are reduced or disappear. The study will also look at the safety and tolerability of the treatment, which means checking for any side effects or reactions to the medication. Participants who have completed a previous phase of the study will continue to receive the treatment to see how it performs over time.

Throughout the study, participants will receive regular injections and will be monitored for any changes in their condition. The study aims to determine if the treatment can help keep the disease under control without the need for corticosteroids, which are often used to reduce inflammation but can have significant side effects. The trial will also assess any adverse events, which are unexpected medical problems that may occur during the study. This research is important for understanding how TEV-48574 can help manage these challenging conditions in the long term.

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 patient will be assessed to ensure they meet the criteria for participation. This includes having achieved a clinical response or remission in a previous study or during the re-induction period of this study.

  2. Step 2

    Maintenance period

    During the maintenance period, the patient will receive the medication TEV-48574, which is a solution for injection administered subcutaneously (under the skin) every four weeks.

    The goal of this period is to maintain clinical remission for ulcerative colitis or an endoscopic response for Crohn's disease.

  3. Step 3

    Re-induction period

    If the patient does not achieve the desired clinical response or remission by week 14, they may enter a re-induction period. This involves continued monitoring and potential adjustments to the treatment plan.

  4. Step 4

    Evaluation at week 44

    At week 44, the patient's condition will be evaluated to determine the effectiveness of the treatment. This includes assessing clinical remission for ulcerative colitis and endoscopic response for Crohn's disease.

    Secondary evaluations will also be conducted, such as checking for corticosteroid-free remission and monitoring for any adverse events.

  5. Step 5

    Long-term extension

    Patients who continue to meet the study criteria may enter a long-term extension phase, where they will continue to receive the medication and be monitored for ongoing effectiveness and safety.

Who can join the trial?

5 criteria

  • Adults, both men and women, can participate. There are no restrictions based on gender.
  • Participants must have either **ulcerative colitis** or **Crohn's disease**. These are types of inflammatory bowel disease (IBD) that cause inflammation in the digestive tract.
  • Participants should have achieved a **clinical response** or **clinical remission** at week 14 of a previous study or during the re-induction period of this study. **Clinical response** means the symptoms have improved, and **clinical remission** means the symptoms have disappeared.
  • Participants who did not achieve a **clinical response** or **clinical remission** at week 14 of the previous study can also participate in the re-induction period of this study.
  • Participants should be within the age range of adults, which typically means 18 years and older.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have not responded to previous treatments for their condition.
  • Patients with a history of certain infections that could affect the study results.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have been diagnosed with certain types of cancer.
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Investigated drugs

TEV-48574 is a medication being studied for its effects on patients with moderate to severe ulcerative colitis or Crohn's disease. It is administered through a subcutaneous injection every four weeks. The study aims to evaluate how well this medication helps maintain clinical remission in ulcerative colitis and endoscopic response in Crohn's disease over a long-term period.

What is already known about the treatment

TEV-48574 – This medication is administered subcutaneously, meaning it is injected under the skin, every four weeks. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe ulcerative colitis and Crohn's disease, which are types of inflammatory bowel disease. The main therapeutic use of TEV-48574 is to maintain clinical remission in ulcerative colitis and achieve an endoscopic response in Crohn's disease. At the molecular level, it works by modulating the immune system to reduce inflammation in the gut. TEV-48574 is classified pharmacologically as an immunomodulator.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of ulcerative colitis is unknown, but it is believed to involve an abnormal immune response. The condition can significantly impact daily life and requires ongoing management.

  • Crohn's Disease

    Crohn's disease is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is characterized by inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, diarrhea, weight loss, and fatigue. The disease often progresses with alternating periods of active symptoms and remission. The inflammation can cause complications such as strictures, fistulas, and malnutrition. The exact cause of Crohn's disease is not fully understood, but it involves a combination of genetic, environmental, and immune factors. Managing the disease requires a comprehensive approach to control symptoms and prevent complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515027-11-00Protocol codeTV48574-IMM-20038Estimated enrolment254 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).