99 Participants Needed

SAR442970 for Ulcerative Colitis

(COLOR UC Trial)

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sanofi
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 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 efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants

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.
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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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR442970 Dose Regimen BExperimental Treatment2 Interventions
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

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