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
Trial Overview
The study tests Icotrokinra, a potential new treatment for Crohn's Disease, against a placebo (a substance with no active drug). It aims to determine the effectiveness and safety of Icotrokinra in improving symptoms.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Placebo Group
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
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
Citations
Icotrokinra maintains standout combination of therapeutic ...
Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical ...
NCT07196722 | A Study of Icotrokinra in Participants With ...
Endoscopic response is defined as > 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 ...
Icotrokinra long-term results affirm promise of targeted oral ...
Overall response rates among patients treated with once daily icotrokinra were maintained through Week 52, with 67% of patients treated with ...
Icotrokinra data in ulcerative colitis show potential for a ...
At Week 12, patients treated with 400 mg of icotrokinra once-daily achieved a clinical response rate of 63.5% versus 27% for placebo (p<0.001), ...
Protagonist Announces New Icotrokinra Data in Ulcerative ...
Icotrokinra demonstrated clinically meaningful outcomes at Week 28 in the Phase 2b ANTHEM-UC study in ulcerative colitis, with 31.7% of ...
Icotrokinra data in ulcerative colitis show potential for a ...
Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving ...
7.
innovativemedicine.jnj.com
innovativemedicine.jnj.com/us/news-center/immunology/icotrokinra-long-term-results-affirm-promise-of-targeted-oral-peptide-with-high-rates-of-durable-skin-clearance-and-favorable-safety-profile-in-difficult-to-treat-scalp-and-genital-psoriasisIcotrokinra long-term results affirm promise of targeted oral ...
Across treatment groups, adverse event and serious adverse event rates were similar through Week 52 compared to those through Week 16, with no ...
A Study of Icotrokinra in participants with moderately ...
... safety of Icotrokinra in participants with moderately to severely active Crohn's Disease ... safety data at baseline, Week I-12, and Week M-40 12. PRO-2 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.