Icotrokinra for Crohn's Disease
(ICONIC-CD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the effectiveness and safety of icotrokinra for individuals with Crohn's disease, which causes severe intestinal inflammation. Participants will receive either icotrokinra or a placebo to assess which better controls symptoms. Those who have had Crohn's disease for at least 12 weeks and experience moderate to severe symptoms may qualify for this study. As a Phase 2 and Phase 3 trial, the research measures the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that icotrokinra is generally safe. In earlier studies on ulcerative colitis, participants tolerated this treatment well. Those who took icotrokinra experienced side effects similar to those who took a placebo (a harmless pill with no effect). This suggests icotrokinra is usually safe for humans.
Other studies on different conditions found that serious side effects were rare, even over long periods. This strongly suggests that icotrokinra is likely safe for people with Crohn's disease as well. However, since everyone is different, it's important to consider individual health situations.12345Why are researchers excited about this trial's treatment?
Researchers are excited about Icotrokinra for Crohn's Disease because it offers a new approach by targeting specific inflammatory pathways that current treatments may not address as precisely. Unlike existing therapies, which typically focus on broad immune suppression, Icotrokinra specifically inhibits certain cytokines, potentially reducing inflammation more effectively and with fewer side effects. This precision in targeting could lead to faster and more sustained relief for patients suffering from Crohn's Disease, making it a promising option compared to the traditional treatments like corticosteroids and immunomodulators.
What evidence suggests that this trial's treatments could be effective for Crohn's disease?
Research has shown that icotrokinra may help treat inflammatory conditions like Crohn's disease. In a similar condition, ulcerative colitis, icotrokinra achieved a 63.5% success rate after 12 weeks, compared to 27% with a placebo. By Week 28, about 31.7% of patients experienced significant improvement. Long-term results indicated that these benefits lasted through Week 52, with many patients continuing to do well. These findings are encouraging for its potential to reduce inflammation in Crohn's disease. Participants in this trial will be assigned to different arms, including those receiving icotrokinra at various doses and those receiving a placebo, to evaluate its effectiveness in treating Crohn's disease.12678
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for people with Crohn's Disease that's moderate to severe. Participants should be adults who have tried other treatments without success or cannot tolerate them. Specific details about what makes someone eligible or not are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive either Icotrokinra or placebo to evaluate clinical response and remission
Maintenance
Participants who respond to induction treatment continue with Icotrokinra or placebo to maintain remission
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Extension
Eligible participants can opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- Icotrokinra
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University