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

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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
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
PreventaMed s.r.o. Olomouc Czechia
Universitair Ziekenhuis Gent Gent Belgium
Elias University Emergency Hospital Bucharest Romania
Amphia Hospital Breda The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
University General Hospital Of Heraklion Heraklion Greece
Endoskopia Sp. z o.o. Sopot Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Poliklinika Borzan d.o.o. Osijek Croatia
POLICLINICA GASTROMOND – REGINA MARIA Constanta Romania
Cabinet Particular Policlinic Algomed S.R.L. Timisoara Romania
Azienda Ospedaliera di Padova Padua Italy
KBC Zagreb Zagreb Croatia
Bodyclinic Sp. z o.o. sp.k. Warsaw Poland
Clinfan Kft. Szekszard Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nice Nice France
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Specijalna Bolnica Medico Rijeka Croatia
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Gastromed Sp. z o.o. Torun Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Poliklinika Solmed d.o.o. Zagreb Croatia
Medrise Sp. z o.o. Lublin Poland
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
University Of Szeged Szeged Hungary
Uniklinikum Salzburg Salzburg Austria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Pracownia Badan Klinicznych Salus Wroclaw Poland
Evckpon skwtpf Slezska Ostrava Czechia
Ssd Eremzgbsd Hcmuupzg Tjxowsu Tilburg The Netherlands
Adsazst Owjojfxqlzo Ukckvgwjnlqbe Cpkqiimzaysy Dawzl Sfdvql E Djvzs Swzbipg Dg Tqmihh Turin Italy
Cstf Da Najmn Vandoeuvre Les Nancy France
Pmwuhmwpa Ivhmsexs Mwjcovpg Matogeslfsva Scuzm Wyeekieyhpys I Akbwkhkokuehh Warsaw Poland
Agodbvs Ojttofjvcoq Nkxkenmaz Sq Aimhglk E Bpdbll E C Aogyqa Aaooojwaqay Alexandria Italy
Uzkoboxzng Dgvwf Sopef Du Rccx Le Snfsjioy Rome Italy
Fawxgbcxy Pxyu Lv Ihjnpzhbggeim Btoxadxnq Ddv Hbuqpjsu Uizogtpowykby Ld Plj Madrid Spain
Ieolbdnt dm Ccyidftiofct Hnuaotlfmub Utkwwkoiipdxf dp Shtrq Eroztvl (ibbehzf Saint Priest En Jarez France
Wsc Wdfjlq Inl Pnhjo Potobdvq Kgdasdb Warsaw Poland
Mcnanpvm Sqp z oyrs Oświęcim Poland
Emkvmcoadeuqrtxaufztwruing Hcmdvkfr oy Aeecgg Athens Greece

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.05.2026
Belgium Belgium
Not yet recruiting
01.05.2026
Bulgaria Bulgaria
Recruiting
01.05.2026
Croatia Croatia
Not yet recruiting
01.05.2026
Czechia Czechia
Not yet recruiting
01.05.2026
France France
Not yet recruiting
01.05.2026
Germany Germany
Not yet recruiting
01.05.2026
Greece Greece
Not yet recruiting
01.05.2026
Hungary Hungary
Not yet recruiting
01.05.2026
Italy Italy
Not yet recruiting
01.05.2026
Poland Poland
Not yet recruiting
01.05.2026
Romania Romania
Not yet recruiting
01.05.2026
Spain Spain
Not yet recruiting
01.05.2026
The Netherlands The Netherlands
Not yet 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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