A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD)
The ICONIC-CD study is currently recruiting adults with moderately to severely active Crohn's disease.
Purpose of this study
The ICONIC-CD study is evaluating an investigational study medication to learn whether it may help improve symptoms and inflammation associated with Crohn's disease.
Researchers also want to better understand the safety of the study medication and its potential role in the treatment of Crohn's disease. Participation is entirely voluntary.
Who may be able to take part?
You may be eligible if you:
Are 18 years of age or older
Have been diagnosed with Crohn's disease
Have moderately to severely active disease
Have not achieved adequate disease control with previous treatments
Additional eligibility criteria apply. A study doctor will determine whether the study is suitable for you.
What does participation involve?
Participants who join the study will be randomly assigned to receive either:
The investigational study medication, or
A placebo
Neither participants nor the study team will know which treatment has been assigned during the study.
Participants will attend scheduled study visits and undergo assessments to help researchers understand how the study medication works and how safe it is. All study-related procedures and study medication will be provided at no cost.
Why is placebo used in this study?
Placebo is commonly used in clinical research to help researchers understand whether a study medication is truly having an effect.
In the ICONIC-CD study:
Participants are assigned by chance (randomly) to a treatment group.
The comparison between study medication and placebo helps researchers determine whether the study medication works and how well it works.
Participants are closely monitored throughout the study by experienced healthcare professionals.
If symptoms worsen or concerns arise during the study, participants are encouraged to contact the study team promptly. The study doctor will assess the situation and discuss the most appropriate next steps based on the participant's medical needs and the study requirements.
The use of placebo is reviewed and approved by regulatory authorities and ethics committees before a study can begin.
Using a placebo comparison is an important scientific method that helps ensure research results are reliable and can ultimately support the development of new treatment options for people living with Crohn's disease.
Why is clinical trial participation important?
Clinical trials help advance medical research and improve understanding of Crohn's disease. Participation by volunteers is essential for the development of potential future treatment options for people living with IBD.
Learn more
For additional information, including participating countries, study locations and complete eligibility criteria, please visit:
ClinicalTrials.gov Identifier: NCT07196722
https://clinicaltrials.gov/study/NCT07196722?term=ICONIC%20IBD&viewType=Card&rank=1
Disclaimer: The investigational study medication being evaluated in the ICONIC-CD study has not been approved for the treatment of Crohn's disease. The purpose of the study is to evaluate its safety and effectiveness.
