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

2 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

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
Endomed s.r.o. Kosice Slovakia
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
Alian s.r.o. Bardejov Slovakia
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
Ip Clinic Sp. z o.o. Lodz Poland
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
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
Clinexpert Kft. Budapest Hungary
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
Semmelweis University Budapest Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
Javorszky Odon Korhaz Vac Hungary
Gastromed Sp. z o.o. Torun Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Gastro Jeka s.r.o. Klatovy Czechia
Gcaqt Bxbhmzl Kbidgwkcd Sed z opeq Klodzko Poland
Vivoaegd &mitw Vygqjnk Szr z ogef Wroclaw Poland
Swnxbxscwmszhovvtau Jahvtwgg Ug Wipperfuerth Germany
Ssdlcjh Cfieqbt Mjixvsrt Shi z offz Poznan Poland
Pdlkbuq Mojlek Sjs z Opbq Erq Pgtdtumkk Poniatowa Poland
Pewekumtieu Ehzwtahqupkb Wroclaw Poland
Asqpbmbm Uxzrjtamzt Hgtmjyki Lorenskog Norway
Wpu Wflysl Izc Pettu Plujhhnf Kvdzxbf 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
01.08.2023
Bulgaria Bulgaria
Not recruiting
01.08.2023
Czechia Czechia
Not recruiting
01.08.2023
Germany Germany
Not recruiting
01.08.2023
Hungary Hungary
Not recruiting
01.08.2023
Italy Italy
Not recruiting
01.08.2023
Norway Norway
Not recruiting
01.08.2023
Poland Poland
Not recruiting
01.08.2023
Slovakia Slovakia
Not recruiting
01.08.2023
Spain Spain
Not recruiting
01.08.2023

Trial locations

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.

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 ID:
2024-515027-11-00
Protocol code:
TV48574-IMM-20038
NCT ID:
NCT05668013
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Phase 3b Study of Guselkumab Compared with Risankizumab in Adults with Moderately to Severely Active Crohn’s Disease

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +7
  • A study to evaluate the safety and effectiveness of MB-001 in adults with moderate to severe ulcerative colitis

    Recruiting

    1 1
    Investigated drugs:
    Poland