SAR442970 for Ulcerative Colitis

(COLOR UC Trial)

Recruiting at 69 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Disqualifiers: Crohn's, Infections, Cancer, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 158 weeks

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment called SAR442970 for individuals with moderate to severe Ulcerative Colitis, a condition causing inflammation and sores in the digestive tract. Participants will receive one of two different dose regimens of the treatment or a placebo, assigned randomly. Suitable participants should have had active Ulcerative Colitis for at least three months and have tried other treatments without success. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to contact the study investigator for more details.

Is there any evidence suggesting that SAR442970 is likely to be safe for humans?

Research shows that SAR442970 is being tested for safety and effectiveness in people with ulcerative colitis, a condition that causes inflammation in the large intestine. Earlier studies on SAR442970 primarily focused on its safety. Although detailed results from these studies are limited, the medication has progressed to a phase 2 trial. This phase typically indicates some early evidence of safety for humans. The phase 2 trial also assesses how well participants tolerate the treatment. Researchers closely monitor participants for any side effects or negative reactions. If earlier studies had revealed major safety issues, the medication likely would not have advanced to this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for Ulcerative Colitis?

SAR442970 is unique because it potentially offers a new way to manage ulcerative colitis by targeting specific pathways involved in inflammation. Most current treatments, like aminosalicylates and corticosteroids, work by broadly suppressing inflammation. In contrast, SAR442970 may work in a more targeted manner, which could lead to fewer side effects and improved effectiveness. Researchers are excited about the potential for two different dosing regimens, which might offer flexible treatment options to better meet individual patient needs.

What evidence suggests that SAR442970 could be an effective treatment for Ulcerative Colitis?

Research has shown that SAR442970 is being tested for its potential to help individuals with moderate to severe ulcerative colitis. The trial includes different treatment arms, where participants receive either SAR442970 dose regimen A, SAR442970 dose regimen B, or a placebo. This treatment targets specific parts of the immune system that may cause inflammation. Early results suggest that SAR442970 might reduce symptoms by calming the immune response. Although limited data exists on its effectiveness for ulcerative colitis, the treatment is being carefully tested to compare its effects to a placebo. This approach appears promising, and researchers hope it will provide relief for those dealing with this challenging condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with moderate to severe Ulcerative Colitis (UC) for at least 3 months, confirmed by endoscopy. Participants must have an inadequate response or intolerance to standard UC treatments like corticosteroids and not been exposed to advanced therapies, or have had an inadequate response to at least one advanced therapy.

Inclusion Criteria

I have had active ulcerative colitis for at least 3 months, confirmed by a recent endoscopy.

I am using birth control as required by local laws for clinical study participants.

I have moderate-to-severe ulcerative colitis with specific symptoms and extent.

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, including dose-ranging and assessment of efficacy and safety

158 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

Open-label extension

Participants may opt into continuation of treatment with SAR442970 for up to 104 weeks

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR442970

Trial Overview The trial is testing the effectiveness of SAR442970 in different doses versus a placebo in treating UC. It's a phase 2b study where participants are randomly assigned and treatment can last up to 158 weeks, with an option for long-term extension.

How Is the Trial Designed?

Group I: SAR442970 Dose Regimen B Experimental Treatment 2 Interventions

Participants will receive SAR442970 dose regimen B

Group II: SAR442970 Dose Regimen A Experimental Treatment 1 Intervention

Participants will receive SAR442970 dose regimen A

Group III: Placebo Placebo Group 1 Intervention

Participants will receive SAR442970-matching placebo

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06975722

NCT06975722 | A Study to Investigate the Efficacy and ... See Delay Results Type in the Results Data ... A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis (COLOR UC).

2. crohnscolitisfoundation.org crohnscolitisfoundation.org/a-study-to-investigate-the-efficacy-and-safety-of-sar442970-adult-participants-with-ulcerative

A study to investigate the efficacy and safety of SAR442970 ... This study is being done to test the effectiveness and safety of an investigational medication called SAR442970 compared to placebo in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06958536

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 ...

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-efficacy-and-safety-of-sar442970-in-adult-participants-with-ulcerative-co

A Study to Investigate the Efficacy and Safety of SAR442970 ... 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 ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SNYNF/pressreleases/34670518/sanofis-promising-ulcerative-colitis-study-what-investors-need-to-know/

Sanofi's Promising Ulcerative Colitis Study: What Investors ... ' The study aims to assess the efficacy and safety of SAR442970, a new treatment for moderate to severe ulcerative colitis, over a period of up ...

6. clinicaltrials.eu clinicaltrials.eu/inn/sar442970/

Sar442970 – Application in Therapy and Current ... This study focuses on patients with moderate to severe ulcerative colitis, a chronic inflammatory condition affecting the large intestine. The research ...