A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD)

Study description/explanation of participation:

ICONIC-CD is evaluating the safety and efficacy of an oral investigational medication for moderately to severely active Crohn’s disease. The investigational medication is a tablet (or pill) that is taken by mouth once a day and does not require an injection or infusion. The investigational medication will be compared to placebo. Placebo looks like the investigational medication but contains no active medication. There are 5 parts to this study. If you complete all 5 parts, your participation in the study will last up to 5 years (approximately 270 weeks). The safety and efficacy of the investigational medication have not been established.

Patient Participation Requirements: 

• Come to all study visit appointments
• Complete a diary and bring it with you to appointments
• Tell the study doctor/staff about any health problems you have during the study
• Tell the study staff about any new medicine or drug you take during the study, including over-the-counter drugs.
• Tell the study staff about any changes to your ongoing medicines or drugs.

Possible risks and side effects: 

Because we are learning about the study medication, all possible side effects and risks related to the study medication are not known and there is the potential that you may experience side effects. All potential side effects will be discussed by the study staff before you begin the study. 

Side effects may range from mild and unpleasant to serious, or even life threatening. If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored.