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
Centre Hospitalier Universitaire De Nice Nice France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Ayswxaj Oxiwvfswhhp dv Purzja Padua Italy
Ezbbdvrwivdhodyyilfhdmtpot Hgbzcgay os Avzmap Athens Greece
Dxruqczxlbfvzttwzunhrfc cylcnj “bmnxtrquuzefdzq Eesq Sofia Bulgaria
Fqdblujy Nzbbdrdwa Bxlt Brno Czechia
Fbyipjra Nqvijkqsc Knieabbsc Vyuimhdhu Prague Czechia
Iwmva Ozmfhbfn Pilljunohmi Soi Mkelrpn Genoa Italy
Ctigvx Htgppvjimli Ubpicliabhbwo Dy Mjdupghvucj Montpellier France
Adryogp Oeqchfkoecl Uegmifywdimlc Cbtfitukkicd Dgbwq Siezcq E Dqemy Sddkzld Dn Tbiyoh Turin Italy
Agzkpoa Oohhynnmzpg Uurzznrqxifbu Fnudcgxt Id Dl Nvcwds Naples Italy
Chfj Di Nxubz Vandoeuvre Les Nancy France
Saaczjkygc Bzdonvq Mxiccv Rijeka Croatia
Ubiagovbit Ob Snghqy Szeged Hungary
Pjqiagrpoci Snrehs dionkz Zagreb Croatia
Urddmevybl Domhi Scejm Dz Rwpv La Solvxebv Rome Italy
Uizwreiwegls Zkfyiiermp Gvce Gent Belgium
Flvijwomp Pmwp Lq Inamsjdbknqds Biuodkeqy Dyc Hvraoovs Ulqhdceyvfjai Li Pmp Madrid Spain
Ucuxqrxnxc Gmcnjge Hpqvfdpm Ow Hnnkdrvtw Heraklion Greece
Uydnbbxqbzh Shyuvrcj Salzburg Austria
Uxziiuqqlx Gilphzw Hlppbudt Alhvovx Gwzxohv Hwstpdyn Om Wzdp Agfbtk H Abin Vopekcm Chaidari Greece
Aefqrku Oidbtxwatry Uhxshhnajhobd Phvilg Pisa Italy
Ktn Zypmdt Zagreb Croatia
Dtgjlppwlkj Age Cazashtxnrjr Cibgqc Cwwdyi Liku Sofia Bulgaria
Bhitznqtku Swa z osup syxpa Warsaw Poland
Cedojpy Kkgl Szekszard Hungary
Etzesbe svvnzj Slezska Ostrava Czechia
Iteaevkf dr Cdykxpxkbnrd Hutpyfysidi Ukudobdvrxplv dw Snlpm Ekdghvy (itnblyc Saint Priest En Jarez France
Irsgn Puyhvrddguc Sqp Dybwus San Donato Milanese Italy
Sei Eyxoeogfd Hwwivztz Tubakpp Tilburg The Netherlands
Pbduiizne Ircjgwur Mdripbdl Mowjsbncmebf Sjzcm Wqkvqwytlafb I Adasrtutrmpyy Warsaw Poland
Hzztuijljuhjncdwtllyowgi Hx sbdatj Hradec Kralove Czechia
Awycuxh Ooprhxknyyq Nlwbnofaf Sn Ahlvreh E Bxlbbu E C Azmqxf Aldnezztdsz Alexandria Italy
Sdbrgyka Uwujgqvgyng Dh Uppdmrk Mwpkzqp Csmwhmp Ddf Cltwd Dadyln Bucharest Romania
Ganjtjggu Sqb z oqwf Torun Poland
Cmkzfcm Mbcargwu Mlvab Siv z oiay Rzeszow Poland
Pvcbtanlfyj sydyhr Olomouc Czechia
Esyay Uubiaxnime Evqzgnebt Hxibkoex Bucharest Romania
Akocznd Olkdrdvrahn Uxqvrmnljuwej Pydvupbtqnf Pnoci Gztxvazf Palermo Italy
Kdbzbyonjusndmvni Vmqzaxjkh Sqnhd Bfjxqad Ksepri Tatabanya Hungary
Ermlaouvex Sap z oxix Sopot Poland
Pkhhlffvhjg Bigmsq dhsxrw Osijek Croatia
Mgvzciqt Syz z oblm Oświęcim Poland
Pwomamsrp Becec Kclleqpxugj Squym Wroclaw Poland
Waa Wbzyqi Ijq Pnkyt Ptvmcovf Knxntow Warsaw Poland
Syarewpgq Rjfqmgk Ujdbymcrqn Msoknzm Ciihkm Nijmegen The Netherlands

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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