SAR442970 for Crohn's Disease

(CHROMA CD Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Standard treatments

Disqualifiers: Ulcerative colitis, Short bowel syndrome, 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 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 efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. 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?

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.

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?

Group I: SAR442970 Dose Regimen B Experimental Treatment 1 Intervention

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 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