A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease (CHROMA CD)

Sanofi

Status and phase: Begins enrollment this month; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: SAR442970; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06958536

2024-517016-30-00 (EU Trial (CTIS) Number)

DRI18450 (Other Identifier)

U1111-1306-7510 (Other Identifier)

Details and patient eligibility

About

This is a phase 2, 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 and the treatment duration is up to 158 weeks

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
• Confirmed diagnosis of moderate-to-severe CD
• History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
• On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion criteria

• Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome

• Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement

• Participants with following ongoing known complications of CD:

  • Any manifestation that might require bowel surgery while enrolled in the study
  • Participant with ostomy or ileoanal pouch
  • Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
  • Participant with surgical bowel resection within the past three months prior to screening, or a history of >3 bowel resections

• History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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99 participants in 3 patient groups, including a placebo group

SAR442970 Dose Regimen A

Experimental group

Description:

Participants will receive SAR442970 dose regimen A

Treatment:

Drug: SAR442970

SAR442970 Dose Regimen B

Experimental group

Description:

Participants will receive SAR442970 dose regimen B

Treatment:

Drug: SAR442970

Placebo

Placebo Comparator group

Description:

Participants will receive placebo

Treatment:

Drug: Placebo