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.
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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