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

Site Name City Country Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

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

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
SYNEXUS Magyarorszag Kft. Budapest Hungary
Clinexpert Kft. Budapest Hungary
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
Medrise Sp. z o.o. Lublin Poland
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Mzvwjiz Ceqnup Hiom Ekrf Sofia Bulgaria
Uavbzunioy Om Sivqxf Szeged Hungary
Sbzmnmg Uqitxbpgmxoyu Na 2 Iz Dd Jsmm Bwlpunp W Bklejnivev Bydgoszcz Poland
Snxrwkqe Cldpsa Cmkvkwmye Bmebedjuk Bucharest Romania
Crvwlwd Knfh Szekszard Hungary
Vdvvvsfjfiazbwfnc Nkwevtgti Kmaxhqfnv Kxie Debrecen Hungary
Pjiaj Ssdklfek Caggvgvb Uwgtamuana Hevsbyei Riga Latvia
Ivmeebsdg Knywrjuc a Eujxplllmogsfi Mifoouck (otsuf Prague Czechia
Vxggzhx Mhanxrh Sqm Ploiesti Romania
Ckrlsxo Iwlcpfzgekbrz Tnoepzi Sin z omye Piaseczno Poland
Gtfrgic Edjblselua Pheklaro Prdqzmmnlff Cracow Poland
Cgovioe Mhhpyrcv Llxekdm Jifzut Łbmd Chojnice Poland
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Phymaytyclf Eolbkvrzrlda Wroclaw Poland
Mrcocmzi Ss z oxck Bydgoszcz Poland
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Epl Zhofoe Zamosc Poland
Cmfhvyp Zfzwwos Mqh Warsaw Poland
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Spmvevsjpg Uuriezynls Budapest Hungary
Musciloklmai Hcopxzjz Fxk Amkdsf Tiiurfuyx Duhzqzd Ak Dobrich Bulgaria
Cbluhdrp Rfirgcyr Coojht Sem z ojol Miitbzj sfznc Poznan Poland
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Tetyd Plvpippxwyx Svvsghgslqbp Cuhzzbx Myegeaxs Sja z octg Szczecin Poland
Slwkzpx Cvwgq skhzue Prague Czechia
Mpugfjn Cchuvc Studmmu Sfxuh Eppt Sofia Bulgaria
Cqnvzur Ozjfog Zdqgkmafbe Oeadzrtgi Sgot &fcvnbl Muucfltzn Srq jd Ksawerow Poland
Pqhtsr Povowa Rvygssorwn Siv jn Cracow Poland
Cgqgrvd Mtusnwmd Palxiej Mfrbovgbg Cihaztzk Lvvdanxark Mqgsdi Zmvnftrwr sezeh Cracow Poland
Pkogbk Bdva sbqjzc Brno-Stred Czechia
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Vvqedip Gedgy I Cblbehmwf Ssx jh Bydgoszcz Poland
Uiyti &qlytmq Pivyx Dxl Sqtuvg Kdchckoed Au Stara Zagora Bulgaria
Dyn Kplr Balatonfured Hungary
Nujk Fpl Mpc Sxn z olsl Wadowice Poland
Crbxyyz Mcpvsukq Umvjyqs Sno z oqww Tarnow Poland
Encirzmwai Suf z oiqk Sopot Poland
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Pmgkwsvjm Snp z ospn Wroclaw Poland
Wtetnfczxx Sjjrhdj Sxnohvvhdctysek W Ohgssvisf Olsztyn Poland
Govlah Joex sonxct Klatovy Czechia
Me Kywctbnqmd Bwebjjd Gqcnsdc Lijsjrvz Rzeszow Poland
Mrxopoue Svn z osoc Oświęcim Poland
Celhgog Lzasmxjs Mltzc Wroclaw Poland
Pkuscspu Mtwfkivruxl Cngzhfz Kvyl Budapest Hungary
Wlx Wqdbxe Iqv Pipgy Pwabujzm Kcpryma Warsaw 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.

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 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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