SAR442970 for Crohn's Disease
(CHROMA CD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medication, SAR442970, for individuals with moderate to severe Crohn's disease, a condition that inflames the digestive tract. The researchers aim to evaluate the effectiveness of different doses of SAR442970 compared to a placebo (a pill with no active medicine). Participants will receive either one of two doses of SAR442970 or a placebo. This trial may suit those who have had Crohn's disease for at least three months and have not found success with standard treatments like steroids or biologics. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop your current medications. In fact, it mentions that participants should be on stable doses of their standard treatments before screening.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that SAR442970 is being tested for safety and effectiveness in treating Crohn's disease. Earlier studies have examined its use for Crohn's disease and other conditions like ulcerative colitis. These studies aim to determine if the treatment is safe and can help reduce symptoms.
Specific information on side effects from these studies is not yet available, but SAR442970's progression to phase 2 trials indicates it has passed initial safety tests in humans. Treatments reach this stage after demonstrating they don't cause serious harm in earlier studies. However, as with any new treatment, some risks or side effects may still be unknown.
Prospective participants should discuss joining this trial with their healthcare provider, who can offer advice based on individual health needs.12345Why are researchers excited about this trial's treatments for Crohn's disease?
SAR442970 is unique because it introduces a fresh approach to treating Crohn's Disease, which is typically managed with anti-inflammatory drugs, immunosuppressants, and biologics. Researchers are excited about SAR442970 because it potentially offers a new mechanism of action, which could improve outcomes for patients who don't respond well to current therapies. This treatment includes two different dosing regimens, A and B, allowing researchers to optimize its effectiveness and minimize side effects. By targeting the disease differently, SAR442970 may provide relief for those who haven't found success with existing options.
What evidence suggests that this trial's treatments could be effective for Crohn's disease?
Research has shown that SAR442970 may help treat moderate to severe Crohn's disease. Studies suggest that this new drug could improve symptoms by targeting specific parts of the body's inflammation process. Early results indicate that SAR442970 might reduce gut inflammation and help manage the disease's progression. Although more research is needed, the initial findings are promising and suggest that SAR442970 could be an effective treatment option for people with Crohn's disease. Participants in this trial will receive either SAR442970 in different dose regimens or a placebo to evaluate its effectiveness and safety.12356
Are You a Good Fit for This Trial?
This trial is for individuals with Crohn's Disease diagnosed at least 3 months ago, experiencing moderate to severe symptoms. Participants must have tried standard treatments or advanced therapies without success or could not tolerate them. They should be on stable doses of certain medications before joining and follow local contraceptive guidelines.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SAR442970 or placebo for up to 158 weeks
Open-label extension
Eligible participants may continue receiving SAR442970 in an open-label extension for up to 104 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SAR442970
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University