Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s Disease

Who can take part?

• Age 18 or older
• Diagnosis of CD established at least 12 weeks before screening 
• Moderately to severely active CD based specific criteria
• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
• Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy [ADT]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder [IR]) as defined in the protocol
• Additional criteria apply

• Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
• Presence of a stoma or ostomy
• Participants with presence of active fistulas may be included if there is no surgery needed
• Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
• Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
• Additional criteria apply

What is involved for me?

• Regular study visits on site at Mater Hospital Brisbane (South Brisbane) for up to 4 years
• Daily eDiary entries
• Blood, stool & urine tests at regular timepoints
• Colonoscopy at specified timepoints
• Daily oral study medication.