This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active CD. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active CD due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 1092 participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).
This study is being done to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) taking azathioprine/6MP or biologic therapy or small molecules are different from those among IBD-affected women not taking these medications. Participants will be asked to give blood samples to assess drug levels during pregnancy and after birth. They will also be asked to answer questionnaires about their and their baby's health.