Study on the Effects of Zasocitinib for Patients with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying a condition known as ulcerative colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study is investigating a new treatment called Zasocitinib, also known by its code name TAK-279. This medication is taken orally in the form of a capsule. The trial will compare the effects of Zasocitinib with a placebo to determine its effectiveness and safety in treating people with moderately to severely active ulcerative colitis.

The purpose of the study is to evaluate whether Zasocitinib can help achieve clinical remission, which means reducing the symptoms of ulcerative colitis, by the 12th week of treatment. Participants in the study will be randomly assigned to receive either the medication or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The trial will last for a total of 52 weeks, with the main focus on the first 12 weeks to assess the initial response to the treatment.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the effects of the treatment. These assessments will include evaluating symptoms such as stool frequency and rectal bleeding, as well as conducting endoscopic examinations to observe the condition of the colon. The study aims to provide valuable information on the potential benefits of Zasocitinib for individuals suffering from ulcerative colitis, with the hope of improving their quality of life.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the medication zasocitinib or a placebo. The placebo is a capsule that looks like the medication but does not contain the active substance.

The study is designed to be double-blind, meaning neither the participant nor the researchers will know who is receiving the actual medication or the placebo.

2 medication administration

The participant will take the assigned capsule orally. The exact dosage and frequency will be provided by the study team, and it is important to follow these instructions carefully.

The medication or placebo will be taken for a period of 12 weeks.

3 monitoring and assessments

Throughout the 12-week period, the participant will undergo regular assessments to monitor the effects of the medication. These assessments may include physical examinations, blood tests, and questionnaires about symptoms and quality of life.

Participants will also be required to keep an electronic diary to record any bowel urgency and abdominal pain experienced during the study.

4 end of treatment evaluation

At the end of the 12-week treatment period, the participant will undergo a final evaluation to assess the effectiveness of the medication. This will include a colonoscopy to examine the condition of the colon.

The primary goal is to determine if the participant has achieved clinical remission, which means a significant reduction in symptoms and inflammation.

5 follow-up

After the treatment period, there may be additional follow-up visits to monitor the participant’s health and any long-term effects of the medication.

Participants will be informed about the results of the study and their individual outcomes once the study is completed.

Who Can Join the Study?

  • The person must be willing and able to understand and follow the study procedures and requirements. They must also provide written consent to participate in the study.
  • The person must be between 18 and 75 years old at the time of signing the consent form.
  • The person must have moderately to severely active ulcerative colitis at the time of screening. This is determined by a specific scoring system called the modified Mayo score, which should be between 5 to 9 points, and an endoscopic subscore of 2 or more. An endoscopic subscore is a part of the scoring system that looks at the inside of the colon using a camera.
  • The person must have a confirmed diagnosis of ulcerative colitis for at least 30 days before screening. This means they need to have had a test called an endoscopy with a biopsy (a small tissue sample) that shows they have ulcerative colitis. The disease should affect more than 15 cm from the anal verge, which is the opening of the anus.
  • If the person has had extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, they must have had a surveillance colonoscopy within 12 months of the initial screening visit. A surveillance colonoscopy is a procedure to check the colon for any changes or problems.
  • If the person has a family history of colorectal cancer, a personal history of increased risk for colorectal cancer, is over 50 years old, or has other known risk factors, they must be up to date on colorectal cancer checks. This can be done during the screening.
  • The person must be willing and able to have a colonoscopy with biopsies during the screening after meeting all other inclusion criteria.
  • The person must have a history of not responding well, losing response, or not being able to tolerate one or more treatments for ulcerative colitis. This includes treatments like 6-mercaptopurine, azathioprine, oral or IV corticosteroids, or biologic agents. Biologic agents are advanced treatments that target specific parts of the immune system.
  • The person must agree to follow the study’s birth control requirements. Female participants who can have children and are sexually active must agree to use effective birth control during the study and for 10 days after the last dose of the study drug. Female participants who cannot have children must be surgically sterile or confirmed to be postmenopausal.

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 recent surgery related to the digestive system.
  • Patients who are currently using certain medications that might affect the study results.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have participated in another clinical trial recently.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have a history of certain infections that could affect the study.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a condition called immunodeficiency, which means their immune system is not working properly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
University Hospital Of Clermont-Ferrand Clermont Ferrand France
EURO-ENDO-MED Kft. Mohács Hungary
IRCCS Humanitas Research Hospital Rozzano Italy
Sydvestjysk Sygehus Esbjerg Denmark
Katholieke Universiteit te Leuven Leuven Belgium
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
San Camillo Forlanini Hospital Rome Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Delta Health Care S.R.L. Bucharest Romania
University General Hospital Of Heraklion Heraklion Greece
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Planetmed Sp. z o.o. Wroclaw Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Accout Center s.r.o. Sahy Slovakia
Fakultna Nemocnica S Poliklinikou Nove Zamky Nove Zamky Slovakia
Endohope klinika s.r.o. Prague Czechia
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Evangelismos S.A. Athens Greece
Clinexpert Kft. Budapest Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Melita Medical sp. z o.o. Wroclaw Poland
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
General University Hospital Of Patras Patras Greece
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Cliniq s.r.o. Bratislava Slovakia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Javorszky Odon Korhaz Vac Hungary
Gastromed Sp. z o.o. Torun Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Medrise Sp. z o.o. Lublin Poland
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Krajska zdravotni a.s. Teplice Czechia
Region Sjaelland Holbæk Denmark
University Hospital Ostrava Ostrava Czechia
Agaplesion Frankfurter Diakonie Kliniken gGmbH Frankfurt Germany
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Aqtj Cqitehrl ssvrqr Prague Czechia
Humtnswy Hojfeycb Hvidovre Denmark
Ergyfyl sfyxxp Slezska Ostrava Czechia
Gxmhbgdwpkj sbpswr Pardubice Czechia
Slx Mdvrqj Ukw Sgw Atiakmlyluegdmczkmgdl Ludwigshafen Am Rhein Germany
Mbjbxcqbaz Squzyb Bucharest Romania
Mqnmtua cbtxyn Aouspbdms hzyvgr mbqijrdt rdzoswpefn Eqws Sofia Bulgaria
Havyyccb Hcijjgas Hillerød Denmark
Lennt Gtbugfq Huoylsdd Oe Aorcdk Athens Greece
Aabznws Owybbvvfdot Ozuosmpd Rdxbzsp Vxofb Squyf Cmmsiiny Palermo Italy
Slzpidsv Cwoucd &yhjyqlbqo Im Cltjpellyklnhnpgzv Bucharest Romania
Psxkyef Pitauguo fcs Gzorahfrbhxchvob Heidelberg Germany
Mxulexdo Sw z ojky Bydgoszcz Poland
Ablmzouv Udsxtuaznh Hqlkcqfj Lorenskog Norway
Ckei Di Nydis Vandoeuvre Les Nancy France
Pfagvdsfa Ipmfdujd Mlaspjkx Mbenyygnwgyd Swifb Wygwlfxjyrbe I Ajmrjicqfiyky Warsaw Poland
Adwbvul Ubhtl Skvtjcesu Lswkef Ds Bbhpkgs Bologna Italy
Iqxeqwzc dz Ckkggtxffees Hyzxzzjaxlf Unieyclqblzau df Sdaku Euofdqx (bhaeyxb Saint Priest En Jarez France
Wog Wahmjd Idi Pdqli Pjmrvtpl Kakmuge Warsaw Poland
Uldphscdop Hlyxarvv Qvbfe Grsrmeq Sofia Bulgaria

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
10.06.2024
Bulgaria Bulgaria
Not recruiting
10.06.2024
Czechia Czechia
Not recruiting
10.06.2024
Denmark Denmark
Not recruiting
10.06.2024
France France
Not recruiting
10.06.2024
Germany Germany
Not recruiting
10.06.2024
Greece Greece
Not recruiting
10.06.2024
Hungary Hungary
Not recruiting
10.06.2024
Italy Italy
Not recruiting
10.06.2024
Norway Norway
Not recruiting
10.06.2024
Poland Poland
Not recruiting
10.06.2024
Romania Romania
Not recruiting
10.06.2024
Slovakia Slovakia
Not recruiting
10.06.2024

Trial locations

Investigated drugs:

TAK-279 is an oral medication being studied for its effectiveness and safety in treating people with moderately to severely active ulcerative colitis. The trial aims to see if this medication can help achieve clinical remission, which means reducing or eliminating the symptoms of ulcerative colitis, by the end of 12 weeks.

Investigated diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to more severe symptoms. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response. The condition can significantly impact a person’s quality of life due to its persistent and unpredictable nature.

Trial ID:
2023-506769-67-00
Protocol code:
TAK-279-UC-2001
NCT ID:
NCT06254950
Trial Phase:
Therapeutic exploratory (Phase II)

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