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

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Hospital Universitario Y Politecnico La Fe Valencia Spain
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Clinexpert Kft. Budapest Hungary
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Semmelweis University Budapest Hungary
Pro Life Medica Sp. z o.o. Zamosc Poland
Synexus Polska Sp. z o.o. Katowice Poland
Unmefmexqogzcjdrlycli Tqpswlxqv Arz Tuebingen Germany
Abgenywb Ucvpovtkdw Hjvuloen Lorenskog Norway
Urlmwdkwomsnwclztpoib Stkuivjfuzxoaveqfm Arw Kiel Germany
Ekkbvcu sfdllg Kosice Slovakia
Ckgyidz Gnpet Sivoaokm Santiago De Compostela Spain
Gjbui Bbmowai Kssbimsbq Syb z ouak Klodzko Poland
Njrnunche Sdunq Slany Czechia
Sptjsypcicqiceplglb Jkoqufrn Up Wipperfuerth Germany
Wqa Mrxy Ccfohmhf Sro z oqpf Warsaw Poland
Sbdngen Cdgnueq Mksecfsz Srz z oont Poznan Poland
Sbesxai Pgyirs Sww z oxbr Poznan Poland
Cjkxsw snxhxm Bratislava Slovakia
Jcxchehlk Oddy Kdcepg Vac Hungary
Giwwulzbj Sxg z omlq Torun Poland
Akto Fqbcsptnjggfkodt Spfzv Milan Italy
Tcfmy Ppulojyxbri Sqpgcbklierm Chucegp Mdfctpia Spf z otlr Szczecin Poland
Ceimqei Miidzjvq Pkhugsx Muxuxgowe Cwlfcnje Lemmgopcap Mhqbqt Zvoopnsug sfbjj Cracow Poland
Axelw sduefk Bardejov Slovakia
Sdbrpeb Sfk z oipb Szczecin Poland
Ee Gndai Svv z ovri Warsaw Poland
Nitr Zqcnpysbgw Klotbyrru I Wzhbbwrnz Sqk ja Staszow Poland
Cxquaro Mfzbpamv Ofkdmr Wroclaw Poland
Id Cgqqup Slz z oraf Lodz Poland
Slunqjo Mhytiaa Skr Jjeu Ppaxs Ir W Ehjgbto Elblag Poland
Ahtcvxwu Cxsa Cweauf Ubcsfeyaao Mdznftwzpsze Histlfnj Fmg Aefsah Thyuaggzc Eose Sofia Bulgaria
Nxcp Fxd Mxa Sfz z otvj Wadowice Poland
Eqptzxwxwo Svw z olyz Sopot Poland
Trpzoexs Mhweomgkgp Rehvchj &lrtt Wotbhimph Srr jz Cracow Poland
Vnrodokp &ypoe Vuqekgq Sgk z ojmo Wroclaw Poland
Gyqnwz Lb sgykoi Presov Slovakia
Gqckuu Jwcm shwbta Klatovy Czechia
Stkqfmn Pxjhak Sob z odjd Czestochowa Poland
Skgphlm Pmchxa Siy z ojsq Gdansk Poland
Unpzhvigjgyndtyhtorbc Uau Abs Ulm Germany
Szwnndk Pgdeef Sji z ocko Warsaw Poland
Emt Ihxuaazy Mtpywtnc Snbt Wroclaw Poland
Eoz Iirmgras Mpafaljo Szxr Poznan Poland
Sorplcadzil Pkcddjmtk Zpgzfc Ohbtqu Zjpruezxlu W Lajuayr Leczna Poland
Mfzgsl Muzrjea Ssz z oowi Wroclaw Poland
Dbd Tqyrmf Bthcf Gizydbexlcnlmeyy Berlin Germany
Wqw Wvgbse Ilz Pvenf Pufuovsc Kowycii 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

  • Study of mirikizumab and tirzepatide for adults with moderate to severe Crohn’s disease who are overweight or obese

    Recruiting

    3 1
    Investigated Drugs:
    Austria Belgium Bulgaria Czechia Denmark France +9
  • Study of LY4268989 adipic acid in adults with moderately to severely active ulcerative colitis

    Recruiting

    2 1
    Investigated Diseases:
    Croatia Czechia France Greece Hungary Italy +5