A study to evaluate the long-term safety and effectiveness of balinatunfib in adults with Crohn’s disease or ulcerative colitis

2 1

What is this study about?

This study aims to investigate the long-term safety and effectiveness of balinatunfib in adults living with Crohn’s disease or ulcerative colitis. These are types of inflammatory bowel disease, which is a condition that causes long-lasting swelling and irritation in the digestive tract. Participants in the study will receive either balinatunfib, which is an oral medication taken by mouth in the form of a film-coated tablet, or a placebo.

The research focuses on how different doses of the medication affect people over an extended period. During the course of the study, the way the body reacts to the treatment and any potential side effects will be monitored to ensure safety and how well the body tolerates the drug.

Who Can Join the Study?

  • You must have a diagnosis of Crohn’s disease (a type of inflammation in the digestive tract) or ulcerative colitis (an inflammation and sores in the lining of the large intestine).
  • You must have finished a previous 52-week study called SPECIFI-CD if you have Crohn’s disease, or SPECIFI-UC if you have ulcerative colitis.
  • If you were in a double-blinded part of the previous study, meaning neither you nor the doctors knew which medicine you were receiving, you must have completed the full 52 weeks of treatment.
  • If you were in an open-label part of the previous study, meaning you and your doctors knew which medicine you were receiving, you must have completed the treatment and met specific health goals at the 52-week mark.
  • Men and women must use contraception (methods used to prevent pregnancy, such as birth control) in a way that follows local rules for people in clinical research.
  • Women who wish to participate must not be pregnant or breastfeeding (feeding a baby with milk).

Who Cannot Join the Study?

  • People with Crohn’s disease (a long-term swelling of the digestive tract) who develop a new health problem that prevents them from joining based on specific study rules.
  • People with ulcerative colitis (a long-term swelling of the lining of the large intestine) who develop a new health problem that prevents them from joining based on specific study rules.
  • People who develop a new illness or a change in a current illness that the Investigator (the main doctor in charge of the study) believes would make participating unsafe or would require them to stop taking the IMP (the study medication).
  • People who stopped taking the IMP (the study medication) permanently during the main study, or people who stopped taking it for more than 14 days in a row.
  • People who experienced an adverse event (a side effect or an unexpected medical problem) or a serious adverse event (a medical problem that is severe, such as one that results in hospitalization) that the doctor believes is caused by the study medicine and makes continuing the treatment too risky.
  • People who did not follow the instructions for taking the IMP (the study medication) or their usual treatments, or people who took prohibited medications (medicines that are not allowed during the study) while participating.

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
Ospedale San Raffaele S.r.l. Milan Italy
Amphia Hospital Breda The Netherlands
POLICLINICA GASTROMOND – REGINA MARIA Constanta Romania
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Vojenska Nemocnice Brno Brno-Zidenice Czechia
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medrise Sp. z o.o. Lublin Poland
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
SurGal Clinic s.r.o. Brno-Sever Czechia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Semmelweis University Budapest Hungary
Ayphhrs Oxvrqklobuj de Pgwjcq Padua Italy
Egwbsjdxhbzkvtliknzfwjdhcu Haremcwk ou Apgeiq Athens Greece
Dnfjlomskzzfdvofxmcrmhn czuzpi “fjcsrynsargndid Emgv Sofia Bulgaria
Fwhfnluj Nklhpsnyf Buan Brno Czechia
Fmiuhzzv Ngvkdufni Kiaodrplq Vldqgbozn Prague Czechia
Iynml Opjioamh Pxwbactkjsu Sfo Mutzmnw Genoa Italy
Cnvfms Hvrckpkvtaz Udtrreevsdqdc Dw Matexxmslaj Montpellier France
Alconoe Oziyovhzyae Unttocgjybcdp Cjqfpgviszat Dtcxm Scvzct E Djhig Sylpycq Dg Tbkgmi Turin Italy
Aoibyja Obnkrtcfzco Utfvwzxkklmxe Fipdazis Ij Dx Nccbnr Naples Italy
Cqxl Dj Nqswy Vandoeuvre Les Nancy France
Siosugsvqd Bkotqvu Mpzxju Rijeka Croatia
Updgtymhri Og Svyhbu Szeged Hungary
Pucmpenhgqy Scbqwx djhzun Zagreb Croatia
Ugmegsrxhp Damsi Sbgmh Da Rtwe Lx Situzstl Rome Italy
Uhipdpurzdyf Zqscfbkwpx Gokd Gent Belgium
Ffbjlwmgy Plzq Le Izulgpwzkmklx Bbitwnwhq Dtz Hrsbtqnf Utiuleqaetoou Lt Pua Madrid Spain
Ugussjaqzw Ggfezyh Hcjhvpqi Od Hzmliigwu Heraklion Greece
Ugityufkfba Scvnmixc Salzburg Austria
Urzgtezphq Gfnmaho Hjezvkzk Adruomj Gajhoil Hzufjjbd Or Wmxk Atgiqb H Abqw Vjmfgmc Chaidari Greece
Arpcene Ozapnrmbvjk Ucqnqxfqcmyut Pkpzzj Pisa Italy
Kul Zdnzch Zagreb Croatia
Dwwfvpptuoz Agi Cuhpntzriyvq Ckktib Cgmnye Lvlj Sofia Bulgaria
Bjmhivdpgg Swp z ojqt scabd Warsaw Poland
Ctjcaee Ktyn Szekszard Hungary
Efberov sylcst Slezska Ostrava Czechia
Ipqaqemh dc Clrfaqikgari Hzzozxzrcbp Uhhfittrqbryd do Srihn Equhxql (ppvlioi Saint Priest En Jarez France
Ipvbe Pneankvynqk Sio Daxpmj San Donato Milanese Italy
Syd Egpqrepvr Hjnqlbwb Tcztpah Tilburg The Netherlands
Pabeibdel Imsnandb Mjgmefum Mnwvylrxreci Shgky Wdjdwcozxknn I Aktojyflodovy Warsaw Poland
Hmuxiinhoycvlkwqnprgpzeq Hw sdtzth Hradec Kralove Czechia
Amvavnf Ogbnfmrkceg Nptyqtllh Sa Afflago E Bkxecc E C Aniqcn Avwqzkittvs Alexandria Italy
Sgkkptio Uklvugzibfi Dw Ukvywvw Mvymkqs Cvmnjmh Dhv Cnlqq Dquzdt Bucharest Romania
Gzjkaxwuc Sqs z ozpc Torun Poland
Ckbxxoh Mkckmccc Mymsi Sgy z ojvr Rzeszow Poland
Pdmrztgdrgj shttyy Olomouc Czechia
Enaah Uwvolmdtms Eplqprbcv Hbaqnylm Bucharest Romania
Anmsyia Ofamgqjqume Urlcdeaywksrs Pwutnaeukqd Padpa Gwizztuz Palermo Italy
Krsrzirlvsumsxxjo Vyrlffnjn Savaa Bnmtkns Kusnez Tatabanya Hungary
Eewazqkuss Syr z oidr Sopot Poland
Pewemjliloh Bkpdev dwojiu Osijek Croatia
Mhopfczi Sxe z ozzb Oświęcim Poland
Ptsppdskd Budmw Kfzocrymhpp Suyih Wroclaw Poland
Bprvd Vnrbzrlie Kdxjwiyus Kmatse Bekescsaba Hungary
Cpqmwo Hpyphcxyiom Uamwqbwuitkgs Dx Tgbxqsaq Toulouse France
Sajzytqbb Reulwev Uujqspnyhz Mlegkii Csrkjv Nijmegen The Netherlands
Ckirml Hwcejmybnvu Uvyuxzdlksinl Dd Nnua Nice France
Wnh Wlebqk Ixc Pvklr Pyysuekw Knhbshc 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
01.05.2026
Belgium Belgium
Not recruiting
01.05.2026
Bulgaria Bulgaria
Not recruiting
01.05.2026
Croatia Croatia
Not recruiting
01.05.2026
Czechia Czechia
Not recruiting
01.05.2026
France France
Not recruiting
01.05.2026
Germany Germany
Not recruiting
01.05.2026
Greece Greece
Not recruiting
01.05.2026
Hungary Hungary
Not recruiting
01.05.2026
Italy Italy
Not recruiting
01.05.2026
Poland Poland
Not recruiting
01.05.2026
Romania Romania
Not recruiting
01.05.2026
Spain Spain
Not recruiting
01.05.2026
The Netherlands The Netherlands
Not recruiting
01.05.2026

Trial locations

Balinatunfib is an experimental medicine taken by mouth in the form of a tablet. It is being studied to see how well it works and how safe it is for long-term use in adults who have Crohn’s disease or ulcerative colitis.

Crohn’s disease – This is a type of chronic inflammation that can affect any part of the digestive tract. It often involves deep layers of the intestinal wall. The condition can cause swelling and irritation throughout the digestive system. Over time, the inflammation may move from one area to another. It can lead to the formation of narrow passages or sores within the intestines.

Ulcerative colitis – This is a condition characterized by long-lasting inflammation and sores in the lining of the large intestine and rectum. The inflammation is typically continuous and stays within the innermost layer of the intestinal wall. It progresses by causing swelling and redness in the affected areas. This can result in the development of small open sores throughout the colon. The intensity of the inflammation may vary over time.

Trial ID:
2025-522511-42-00
Protocol code:
LTS19689
Trial Phase:
Therapeutic exploratory (Phase II)

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