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.
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
Eyrohih swxycn
Slezska Ostrava
Czechia
Ssv Enyfxlvlt Hrdopxlj Tznirjm
Tilburg
The Netherlands
Anbteur Ozqzrrlcvll Ulvbdncgmfysd Cviooiiadzhg Dbsxr Szxjdq E Dvbzb Sguaphu Do Ttluul
Turin
Italy
Cckq Dx Nxzfr
Vandoeuvre Les Nancy
France
Pphafciql Ihpzltms Mbyqloyx Mhqgbvbmnmfy Ssfas Winuhhpzzznk I Aeerjmfhhfkms
Warsaw
Poland
Aovdurl Oltvicdgqwe Nwpfroavx Se Ammyqmz E Bhvcmk E C Atchrt Aytxjkfdjtu
Alexandria
Italy
Upaysoygar Duyhn Srqrq Dc Rxph Ll Seythhhb
Rome
Italy
Fuqnrnlfx Pxyu Lv Ilpmyucbshpkc Bgulremee Dom Hwvigmoq Ucnbhpkrkyeqc Lv Pyf
Madrid
Spain
Ivckckkx da Cnnyqslnucqe Hqceiqdubcx Udilmhxzmyauu di Ssodx Ekkqnra (vqlgwko
Saint Priest En Jarez
France
Whm Wtyxvc Isk Pmglu Phijxgdv Ktowhfw
Warsaw
Poland
Mozunucw Swv z ontc
Oświęcim
Poland
Elxvmobjbclibzyeuutqljzxnw Heemobyi oh Amresn
Athens
Greece
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Austria
Not yet recruiting
01.05.2026
Belgium
Not yet recruiting
01.05.2026
Bulgaria
Recruiting
01.05.2026
Croatia
Not yet recruiting
01.05.2026
Czechia
Not yet recruiting
01.05.2026
France
Not yet recruiting
01.05.2026
Germany
Not yet recruiting
01.05.2026
Greece
Not yet recruiting
01.05.2026
Hungary
Not yet recruiting
01.05.2026
Italy
Not yet recruiting
01.05.2026
Poland
Not yet recruiting
01.05.2026
Romania
Not yet recruiting
01.05.2026
Spain
Not yet recruiting
01.05.2026
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.
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