99 Participants Needed

SAR442970 for Crohn's Disease

(CHROMA CD Trial)

Recruiting at 72 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sanofi
Must be taking: Standard treatments
Prior Safety DataThis treatment has passed at least one previous human 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.12345

Why 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

I am following local guidelines for contraception while in this study.
I have been diagnosed with Crohn's Disease for at least 3 months.
I have been diagnosed with moderate-to-severe Crohn's disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SAR442970 or placebo for up to 158 weeks

158 weeks

Open-label extension

Eligible participants may continue receiving SAR442970 in an open-label extension for up to 104 weeks

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • SAR442970
Trial Overview The study tests the effectiveness and safety of SAR442970 in different doses against a placebo in treating Crohn's disease. It's a phase 2b, double-blind trial that includes an open-label extension period for eligible participants, lasting up to 168 weeks.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR442970 Dose Regimen BExperimental Treatment1 Intervention
Group II: SAR442970 Dose Regimen AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

NCT06958536 | A Study to Investigate Efficacy and Safety ...This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the ...
A study to investigate efficacy and safety of SAR442970 in ...The purpose of the CHROMA-CD study is to find out if SAR442970 is safe and effective in improving the symptoms of CD.
SAR442970 for Crohn's Disease (CHROMA CD Trial)The CHROMA CD medical study, being run by Sanofi, is evaluating whether SAR442970 will have tolerable side effects & efficacy for patients with Crohn's ...
Sanofi's Promising Crohn's Disease Study: What Investors ...The study aims to assess the efficacy of SAR442970, a new drug, compared to a placebo in treating moderate to severe Crohn's disease. This study ...
NCT06975722 | A Study to Investigate the Efficacy and ...This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the ...
A Study to Investigate Efficacy and Safety of SAR442970 in ...Clinical trial for Crohn's Disease , A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease.
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