A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

To be considered for this study, you would generally need to be an adult between 18 and 75 years old who has previously taken part in another study (called TV48574-IMM-20036). You would have either shown signs of improvement in your Crohn's disease or ulcerative colitis during that previous study, or you are now entering a new phase of this current study to see if your condition can improve.

There are also some reasons why you might not be able to join. For example, if you stopped the previous study early, for any reason. Also, if you have other health conditions or are taking other treatments that might interfere with this study, or if the research team feels it might put your health at risk, you wouldn't be able to participate. If you are pregnant, breastfeeding, or planning to become pregnant during the study, you would not be eligible. If a woman becomes pregnant during the study, she would need to withdraw. You also shouldn't be anticipating any major surgery during the study period.

If you join this study, your initial participation in the main 'double-blind' part would last for about 66 weeks (roughly 1 year and 3 months). During this time, neither you nor your study doctor will know which specific dose of TEV-48574 you are receiving. After this initial period, if you are eligible and choose to continue, you might move into an 'open-label extension' phase, which could last for up to an additional 268 weeks (over 5 years).

During your time in the study, you would receive the study medication (TEV-48574) as an injection under the skin every four weeks. You would attend regular appointments at the study clinic throughout these periods for various assessments. These appointments would involve checking your general health, monitoring your Crohn's or ulcerative colitis symptoms, and evaluating how you are responding to the medication, as well as checking for any side effects or changes in your immune system.