SAR441566 for Ulcerative Colitis

(SPECIFI-UC Trial)

Recruiting at 130 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Cyclosporine, Tacrolimus, Mycophenolate, Thalidomide

Disqualifiers: Active CD, Active TB, HIV, others

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

Compensation: Varies

Number of Visits: 20

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, SAR441566, to determine if it can help individuals with moderate-to-severe ulcerative colitis (a condition causing inflammation and sores in the large intestine) achieve clinical remission. Researchers aim to assess the effectiveness and safety of various doses of this treatment compared to a placebo (a substance with no active drug). The trial seeks adults who have had active ulcerative colitis for at least three months and have not responded well to other treatments. Participants will receive one of several doses of SAR441566 or a placebo for up to 52 weeks. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who have used certain medications like cyclosporine, tacrolimus, or IV corticosteroids shortly before the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that SAR441566 is likely to be safe for humans?

Research shows that SAR441566 is being tested for safety and effectiveness in treating moderate-to-severe ulcerative colitis. Patients have generally tolerated this treatment well so far. However, as this is a Phase 2 study, more information is needed to confirm its safety before widespread use.

In earlier studies, some patients experienced mild side effects, but these were not serious enough to discontinue treatment. These studies are crucial for understanding the treatment's safety and potential side effects. Always consult a healthcare provider for more details and to determine if this trial might be suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about SAR441566 for ulcerative colitis because it offers a potentially novel approach to treating this condition. Unlike standard treatments that often involve anti-inflammatory drugs like mesalamine or immunosuppressants such as azathioprine, SAR441566 may work through a different mechanism, targeting specific pathways involved in the disease's progression. This unique action could lead to improved outcomes for patients, especially those who have not responded well to existing therapies. Additionally, the trial is exploring multiple dosing regimens, which could help optimize its effectiveness and safety profile. This innovative approach has the potential to bring new hope to those living with ulcerative colitis.

What evidence suggests that SAR441566 might be an effective treatment for ulcerative colitis?

Research has shown that SAR441566 might help treat moderate-to-severe ulcerative colitis. Early results suggest this medication could reduce or even eliminate symptoms, achieving clinical remission. In this trial, participants will receive SAR441566 in different dose regimens to determine the most effective one. While specific results from human trials are not yet available, the goal is to improve patient health. Scientists remain hopeful about its potential because it targets the disease directly. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe ulcerative colitis. Participants must be able to complete a screening, follow a year-long treatment plan, and attend up to 20 clinic visits. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

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

My ulcerative colitis is active and severe, scoring 5 to 9 on the Mayo scale.

I have previously been treated for urinary cancer as required.

Exclusion Criteria

Participants with specific ongoing known complications of UC

Participants with specific positive findings in fecal samples

Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-5 weeks

Induction Treatment

Participants receive induction treatment for 12 weeks to assess initial efficacy and safety

12 weeks

4 visits (in-person)

Maintenance Treatment

Participants continue treatment for 40 weeks to maintain clinical remission

40 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Open-label Extension

Eligible participants may opt into continuation of treatment for up to 40 weeks

40 weeks

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SAR441566

Trial Overview The study tests SAR441566's effectiveness in achieving clinical remission of ulcerative colitis compared to a placebo. It's double-blind and includes an induction period (12 weeks), maintenance period (40 weeks), followed by an open-label phase for eligible participants.

How Is the Trial Designed?

Group I: SAR441566 dose regimen 3 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 3

Group II: SAR441566 dose regimen 2 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 2

Group III: SAR441566 dose regimen 1 Experimental Treatment 1 Intervention

Participants will receive SAR441566 dose regimen 1

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive SAR441566-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/NCT06867094

NCT06867094 | A Study to Investigate Efficacy and Safety ... The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-sar441566-for-adults-with-moderate-to-severe-ulcerative-colitis/

Study on the Effectiveness and Safety of SAR441566 for ... The purpose of the study is to evaluate how effective and safe this treatment is for adults who have moderate-to-severe forms of ulcerative colitis.

3. trialx.com trialx.com/clinical-trials/listings/296938/a-study-to-investigate-efficacy-and-safety-of-sar441566-in-patients-with-ulcerative-colitis/

A Study to Investigate Efficacy and Safety of SAR441566 in ... The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/547722

A Study to Investigate Efficacy and Safety of SAR441566 in ... The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SNY/pressreleases/33222462/sanofis-promising-phase-2-study-on-sar441566-for-ulcerative-colitis/

Sanofi's Promising Phase 2 Study on SAR441566 for ... The study aims to assess the efficacy of different doses of SAR441566 in achieving clinical remission in patients with moderate-to-severe ulcerative colitis.

6. sanofi.com sanofi.com/en/clinical-trials/nct06867094

Study of Investigational Medication for Ulcerative Colitis A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis. Recruiting. AI Simplified Original. NCT06867094. Colitis Ulcerative ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-efficacy-and-safety-of-sar441566-in-patients-with-crohns-disease

A Study to Investigate Efficacy and Safety of SAR441566 in ... The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.