Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Fast replyInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 new treatment for two types of inflammatory bowel diseases: Ulcerative Colitis and Crohn's Disease. These conditions cause inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and fatigue. The treatment being tested is called TEV-48574, which is a solution for injection. It contains an active substance known as Duvakitug, a type of protein designed to help reduce inflammation by targeting specific pathways in the body. The study will also use a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate how effective and safe TEV-48574 is for patients with moderate to severe forms of these diseases. Participants will receive the treatment or placebo through subcutaneous injections, which means the solution is injected under the skin. The study will last for 14 weeks, during which the treatment will be administered every two weeks. Researchers will monitor the participants to see if the treatment helps achieve clinical remission, which means a significant reduction or disappearance of symptoms, and an endoscopic response, which is an improvement seen during a medical examination of the intestines.

Throughout the study, the safety and tolerability of TEV-48574 will be closely observed. This includes checking for any side effects, changes in laboratory test results, and overall health indicators like blood pressure and heart rate. The study aims to provide valuable information on whether TEV-48574 can be a beneficial treatment option for people living with Ulcerative Colitis and Crohn's Disease.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, ability to communicate, and understanding of the study's nature.

    Participants must be adults aged 18 to 75 and able to comply with study requirements.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status. This includes clinical laboratory tests, vital signs measurements, and a 12-lead electrocardiogram (ECG).

  3. Step 3

    Treatment administration

    The medication TEV-48574 is administered as a solution for injection under the skin every two weeks.

    A placebo, which looks like the medication but does not contain the active ingredient, may also be administered.

  4. Step 4

    Ongoing monitoring

    Participants are monitored for any adverse events and changes in clinical laboratory test results, vital signs, and ECG findings.

    Local tolerability at the injection site is also assessed.

  5. Step 5

    Efficacy assessment

    The primary goal is to evaluate the effectiveness of TEV-48574 in achieving clinical remission in ulcerative colitis and endoscopic response in Crohn's disease by week 14.

    Secondary assessments include clinical response and endoscopic improvement in ulcerative colitis, and clinical response and remission in Crohn's disease.

  6. Step 6

    Immunogenicity evaluation

    The presence of anti-drug antibodies is checked at weeks 2, 4, 8, 14, and during a follow-up visit to assess the body's immune response to the medication.

  7. Step 7

    Completion of study

    The study concludes after 14 weeks of treatment, with a final assessment to evaluate the overall safety and effectiveness of the medication.

Who can join the trial?

5 criteria

  • Adults, both men and women, aged between 18 and 75 years old can participate.
  • The patient must be able to communicate well with the study team and follow the study's requirements.
  • The patient should understand what the study is about and any possible risks involved.
  • Women who cannot have children, either due to surgery (like removal of the uterus or ovaries) or naturally, or who have not had a period for at least one year, can participate.
  • Men, including those who have had a vasectomy, with partners who can become pregnant, must use condoms during the study and for 50 days after the last dose of the study medication.

Who cannot join the trial?

15 criteria

  • Patients who have other serious health conditions that could 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 or sensitivity to the study medication.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of blood clotting disorders.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who have received certain medications that could interfere with the study.
  • Patients who have been vaccinated with a live vaccine within the last 30 days.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

TEV-48574 is an investigational medication being studied for its potential to help patients with moderate to severe ulcerative colitis or Crohn's disease. The trial aims to evaluate how effective this medication is in inducing clinical remission for ulcerative colitis and achieving an endoscopic response for Crohn's disease. The medication is administered every two weeks, and the study focuses on understanding its safety, tolerability, and how it behaves in the body over a 14-week period.

What is already known about the treatment

TEV-48574 – This medication is administered subcutaneously every two weeks and is currently being studied in clinical trials for its effectiveness in treating moderate to severe ulcerative colitis and Crohn's disease. It is in the investigational stage, with ongoing research to determine its safety and efficacy. The main therapeutic indications are for inflammatory bowel diseases, specifically targeting ulcerative colitis and Crohn's disease. TEV-48574 works by modulating the immune response at the molecular level, aiming to reduce inflammation and promote healing in the intestinal tract. It is classified pharmacologically as an immunomodulator.

Investigated diseases

  • Crohn's Disease

    Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It can cause a range of symptoms, including abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can occur in patches and may penetrate deep into the layers of the bowel tissue. Over time, this can lead to complications such as strictures, fistulas, and malnutrition. The disease often progresses with periods of remission and flare-ups. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory bowel disease that primarily affects the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the colon, leading to symptoms such as diarrhea, abdominal pain, and rectal bleeding. The inflammation usually begins in the rectum and can extend to involve the entire colon. Over time, the disease can cause complications like severe bleeding, perforation of the colon, and increased risk of colon cancer. The progression of ulcerative colitis involves alternating periods of remission and exacerbation. The exact cause is not fully understood, but it is thought to involve an abnormal immune response to gut bacteria.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511089-36-00Protocol codeTV48574-IMM-20036Estimated enrolment297 patientsSponsorTeva Branded Pharmaceutical Products R&D LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).