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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
ASST Fatebenefratelli Sacco Milan Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Sonomed Sp. z o.o. Szczecin Poland
Eb Group Sp. z o.o. Warsaw Poland
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Nzoz For Med Sp. z o.o. Wadowice Poland
Endoskopia Sp. z o.o. Sopot Poland
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Gastro LM s.r.o. Presov Slovakia
Nemocnice Slany Slany Czechia
Melita Medical sp. z o.o. Wroclaw Poland
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Synexus Polska Sp. z o.o. Poznan Poland
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
CHC MontLegia Liege Belgium
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Javorszky Odon Korhaz Vac Hungary
Gastromed Sp. z o.o. Torun Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Universitaire De Caen Normandie Caen France
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Gastro Jeka s.r.o. Klatovy Czechia
Gzgzb Bifbnoi Kobhcseqb Som z opht Klodzko Poland
Vonmfebt &czil Vuasxhi Shv z oyzr Wroclaw Poland
Sqplksvhptanxvjdzic Jllxbewz Uh Wipperfuerth Germany
Pyyzgpnzeqw Evzttzmdljei Wroclaw Poland
Awjbqqdc Uklidtcyzx Hjpqieev Lorenskog Norway
Cpsc Dt Nazqx Vandoeuvre Les Nancy France
Ufdqtlyecq On Atdiaxo Edegem Belgium
Iycnfqmn Ohkyzapthhsmuqm Da lpklpmsnubcfc Jwcqd Vtxxj Nantes France
Imbcccuf db Cmdssohrpzie Hawbklhlioa Uuzjhrueiyrct dl Sjilt Exawzfv (gqwhvhu Saint Priest En Jarez France
Wpl Wgccdg Iyu Ptyjg Phdoyvly Kuspxyd Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.03.2023
Belgium Belgium
Not recruiting
01.03.2023
Bulgaria Bulgaria
Not recruiting
01.03.2023
Czechia Czechia
Not recruiting
01.03.2023
France France
Not recruiting
01.03.2023
Germany Germany
Not recruiting
01.03.2023
Hungary Hungary
Not recruiting
01.03.2023
Italy Italy
Not recruiting
01.03.2023
Norway Norway
Not recruiting
01.03.2023
Poland Poland
Not recruiting
01.03.2023
Slovakia Slovakia
Not recruiting
01.03.2023
Spain Spain
Not recruiting
01.03.2023

Trial locations

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.

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 ID:
2024-511089-36-00
Protocol code:
TV48574-IMM-20036
NCT ID:
NCT05499130
Trial Phase:
Therapeutic exploratory (Phase II)

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