Study on the Effectiveness and Safety of PB016 and Vedolizumab for Patients with Moderately to Severely Active Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying a condition called 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 comparing two treatments: an investigational treatment known as PB016 and a licensed treatment called Entyvio. Both treatments involve the use of a substance called vedolizumab, which is a type of protein designed to help reduce inflammation in the gut.

The purpose of the study is to evaluate how well PB016 works and how safe it is compared to Entyvio in people with moderately to severely active ulcerative colitis. Participants in the study will receive one of these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 46 weeks, during which participants will be monitored to see how their condition responds to the treatment. The study will also look at the safety of the treatments and any potential side effects.

Throughout the study, participants will have regular check-ups to assess their health and the effectiveness of the treatment. This includes monitoring changes in symptoms and any improvements in their condition. The study aims to provide valuable information on the potential benefits and risks of using PB016 compared to Entyvio for treating ulcerative colitis, helping to improve future treatment options for this condition.

1 initial visit and randomization

Upon joining the study, participants will attend an initial visit where eligibility is confirmed. This includes a review of medical history and current medications.

Participants will be randomly assigned to receive either the investigational treatment PB016 or the licensed treatment Entyvio®.

2 treatment administration

Participants will receive the assigned treatment through an intravenous (IV) infusion. This involves administering the medication directly into a vein.

The treatment consists of vedolizumab, administered as a 300 mg dose in the form of a solution for infusion.

3 induction phase

The initial phase of the study, known as the induction phase, lasts for 6 weeks. During this time, the effectiveness of the treatment in reducing symptoms will be evaluated.

Participants will have regular check-ups to monitor their response to the treatment and any side effects.

4 maintenance phase

Following the induction phase, participants who respond to the treatment will enter the maintenance phase, which continues up to 52 weeks.

During this phase, the ongoing effectiveness and safety of the treatment will be assessed through regular visits and evaluations.

5 end of study

At the end of the study period, participants will have a final evaluation to assess the overall impact of the treatment on their condition.

Participants will be informed about the results of the study and any further steps regarding their treatment.

Who Can Join the Study?

  • Age between 18 and 80 years at the time of screening.
  • Females who can have children must not be pregnant or breastfeeding. They should either be unable to have children or use highly effective birth control methods.
  • Male participants who are sexually active with women who can have children must use highly effective birth control methods and must not donate sperm for 30 days after the last dose of the study drug.
  • Must have been diagnosed with moderate to severe ulcerative colitis (UC) at least 6 months before screening. This diagnosis should be confirmed by medical tests and a doctor.
  • Must have active UC with a specific score (Mayo score of 6 to 12) and a certain level of inflammation in the colon, confirmed by a central reader within 28 days before starting the study.
  • Must have UC that affects more than 15 cm of the colon beyond the rectum.
  • If you have extensive colitis or pancolitis for more than 8 years, or left-sided colitis for more than 12 years, you must have had a colonoscopy within 12 months before the initial screening visit.
  • If you have a family history of colorectal cancer, personal risk factors, are over 45 years old, or have other known risk factors, you must be up-to-date with colorectal cancer screenings.
  • Must have shown an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunomodulators, or Tumor Necrosis Factor alpha (TNFα) antagonists.
  • May be taking certain medications, such as oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, probiotics, antidiarrheals, azathioprine, or 6-mercaptopurine, as long as the dose has been stable for a specified period before starting the study.
  • Must be able to participate in all aspects of the clinical study.
  • Must voluntarily agree to participate and provide informed consent.

Who Cannot Join the Study?

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients who have a history of severe allergic reactions to any medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years, except for certain skin cancers.
  • Patients who have had a major surgery within the last 12 weeks.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of liver disease.
  • Patients who have a history of kidney disease.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of blood disorders.
  • Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who are currently taking medications that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Endomedix Kft. Miskolc Hungary
University Of Pecs Pecs Hungary
CENTRUM MEDYCZNE REUMA PARK Warsaw Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz Warsaw Poland

Other Sites

Site Name City Country Status
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Medical Center Hera EOOD Sofia Bulgaria
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
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
Pratia Brno s.r.o. Brno-Stred Czechia
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Pauls Stradins Clinical University Hospital Riga Latvia
Medical Centre Synexus Sofia EOOD Sofia Bulgaria
Semmelweis University Budapest Hungary
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
SYNEXUS Magyarorszag Kft. Budapest Hungary
Clinexpert Kft. Budapest Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Clinfan Kft. Szekszard Hungary
Melita Medical sp. z o.o. Wroclaw Poland
Multiprofile Hospital For Active Treatment Dobrich AD Dobrich Bulgaria
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Synexus Czech s.r.o. Prague Czechia
Centrum Opieki Zdrowotnej Orkan-Med Stec – Michalska Sp. j. Ksawerow Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
DRC Kft. Balatonfured Hungary
Nzoz For Med Sp. z o.o. Wadowice Poland
Centrum Medyczne Uno-Med Sp. z o.o. Tarnow Poland
Endoskopia Sp. z o.o. Sopot Poland
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j. Cracow Poland
Planetmed Sp. z o.o. Wroclaw Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
Centrum Leczenia MIGRE Wroclaw Poland
Gastro Jeka s.r.o. Klatovy Czechia
Centrum Zdrowia MDM Warsaw Poland
Pannonia Maganorvosi Centrum Kft. Budapest Hungary
Phiepdblc Iillglph Mmptfryr Mqbuikwjbxaz Soojs Wbshjjumbeqr I Aqmpuxgysdxid Warsaw Poland
Voaxfdqgejhfzuevl Nakldqfyp Kdjjyqxiu Kcsa Debrecen Hungary
Iwxhftrgp Kipthcpk a Ezivombycjhumx Mfwyqcmn (rsgcy Prague Czechia
Viqxqzz Mzhqvig Sdb Ploiesti Romania
Caxihps Iykvxzfhiosvy Trluqqd Sml z opou Piaseczno Poland
Eoxnokk scavoh Kosice Slovakia
Cdlqdcz Mxxxfcou Lmdiejh Jmhmmk Łtgv Chojnice Poland
Phqcbexogyu Ecxdygbdtiia Wroclaw Poland
Mvrdtsdf Ss z onwm Bydgoszcz Poland
Pflod Huogbalpr Pawpvwtneyd Wroclaw Poland
Efw Zcukwl Zamosc Poland
Etv Lygohe Lublin Poland
Gpzuosc Ejbfjobqod Pshfecwo Pjwxyfpntsm Cracow Poland
Kxlxuen zyikiwkpx agyc &qrrknv Mmilknreae nxzxfrncv Úrjs njb Lwjmqa ovji Usti Nad Labem Czechia
Wox Wsjowo Ikj Pxtgt Pqzksics Kjfuozh Warsaw Poland
Mdmfndum Sds z ooph Oświęcim Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
13.06.2023
Czechia Czechia
Not recruiting
13.06.2023
Hungary Hungary
Not recruiting
13.06.2023
Latvia Latvia
Not recruiting
13.06.2023
Poland Poland
Not recruiting
13.06.2023
Romania Romania
Not recruiting
13.06.2023
Slovakia Slovakia
Not recruiting
13.06.2023

Trial locations

Investigated drugs:

PB016 is an experimental medication being tested in this clinical trial. It is designed to help people with ulcerative colitis, a condition that causes inflammation and sores in the colon. The goal of this medication is to reduce the symptoms of ulcerative colitis, such as abdominal pain and diarrhea, and help patients achieve remission, which means the symptoms are reduced or disappear.

Entyvio® is a medication already used to treat ulcerative colitis. It works by targeting specific proteins in the body to reduce inflammation in the colon. This medication is used to help patients with ulcerative colitis feel better by decreasing symptoms and helping them maintain remission over time. In this trial, Entyvio® is being compared to PB016 to see if they have similar effects on patients with ulcerative colitis.

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 the formation of ulcers. The disease typically begins in the rectum and may extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can cause frequent and urgent bowel movements. Over time, the disease can lead to complications such as severe bleeding or perforation of the colon.

Trial ID:
2022-502778-18-00
Protocol code:
PB016-03-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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