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

March 25, 2026 updated by: Sanofi

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Australia
      • Footscray, Australia, 3011
        • Recruiting
        • Investigational Site Number: 0360001
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Investigational Site Number: 0360002
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Recruiting
        • Investigational Site Number: 0360004
  • Belgium
      • Leuven, Belgium, B-3000
        • Recruiting
        • Investigational Site Number: 0560001
  • China
      • Changsha, China, 410011
        • Recruiting
        • Investigative Site: 1560003
      • Changsha, China, 410013
        • Recruiting
        • Investigational Site Number: 1560008
      • Changzhou, China, 213003
        • Recruiting
        • Investigative Site: 1560005
      • Guangzhou, China, 510655
        • Recruiting
        • Investigational Site Number: 1560001
      • Hangzhou, China, 310009
        • Recruiting
        • Investigational Site Number: 1560006
      • Nanchang, China, 330006
        • Recruiting
        • Investigative Site: 1560004
      • Shanghai, China, 200092
        • Recruiting
        • Investigative Site: 1560002
      • Shenyang, China, 110004
        • Recruiting
        • Investigational Site Number: 1560007
  • Czechia
      • Hradec Králové, Czechia, 50012
        • Recruiting
        • Investigational Site Number: 2030003
      • Slaný, Czechia, 274 01
        • Recruiting
        • Investigational Site Number: 2030005
    • JM
      • Brno, JM, Czechia, 61500
        • Recruiting
        • Investigational Site Number: 2030002
  • France
      • Montpellier, France, 34090
        • Recruiting
        • Investigational Site Number: 2500001
      • Nice, France, 6000
        • Recruiting
        • Investigational Site Number: 2500003
      • Toulouse, France, 31059
        • Recruiting
        • Investigational Site Number: 2500002
  • Germany
      • Jena, Germany, 07747
        • Recruiting
        • Investigational Site Number: 2760003
      • Kiel, Germany, 24105
        • Recruiting
        • Investigational Site Number: 2760004
      • Ulm, Germany, 89081
        • Recruiting
        • Investigational Site Number: 2760001
    • Northwest
      • Minden, Northwest, Germany, 32423
        • Recruiting
        • Investigational Site Number: 2760002
  • Japan
      • Bunkyō City, Japan, 113-8519
        • Recruiting
        • Investigational Site Number: 3920004
      • Hamamatsu, Japan, 431-3192
        • Recruiting
        • Investigational Site Number: 3920003
      • Hirosaki, Japan, 036-8545
        • Recruiting
        • Investigational Site Number: 3920009
      • Morioka, Japan, 020-8505
        • Recruiting
        • Investigational Site Number: 3920001
      • Nishinomiya, Japan, 663-8501
        • Recruiting
        • Investigational Site Number: 3920002
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Recruiting
        • Investigational Site Number: 3920007
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-0033
        • Recruiting
        • Investigational Site Number: 3920005
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Recruiting
        • Investigational Site Number: 3920006
  • Poland
      • Krakow, Poland, 31-501
        • Recruiting
        • Investigational Site Number: 6160001
      • Lublin, Poland, 20-582
        • Recruiting
        • Investigational Site Number: 6160005
      • Sopot, Poland, 81-756
        • Recruiting
        • Investigational Site Number: 6160006
      • Warsaw, Poland, 01-783
        • Recruiting
        • Investigational Site Number: 6160003
      • Warsaw, Poland, 00-189
        • Recruiting
        • Investigational Site Number: 6160008
      • Wroclaw, Poland, 54-206
        • Recruiting
        • Investigational Site Number: 6160004
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
        • Recruiting
        • Investigational Site Number: 6160002
  • South Africa
      • Johannesburg, South Africa, 1619
        • Recruiting
        • Investigational Site Number: 7100003
  • Spain
      • Madrid, Spain, 28003
        • Recruiting
        • Investigational Site Number: 7240002
      • Madrid, Spain, 28046
        • Recruiting
        • Investigational Site Number: 7240001
      • Seville, Spain, 41009
        • Recruiting
        • Investigational Site Number: 7240003
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
        • Recruiting
        • Investigational Site Number: 8260007
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Investigational Site Number: 8260004
      • London, United Kingdom, HA8 0AD
        • Recruiting
        • Investigational Site Number: 8260002
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Investigational Site Number: 8260001
      • London, United Kingdom, E11 1NR
        • Recruiting
        • Investigational Site Number: 8260005
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Investigational Site Number: 8400024
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Investigational Site Number: 8400005
      • Lancaster, California, United States, 93534
        • Recruiting
        • Investigational Site Number: 8400001
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • Investigational Site Number: 8400017
      • Lighthouse PT, Florida, United States, 33064
        • Recruiting
        • Investigational Site Number: 8400015
      • Miami, Florida, United States, 33136
        • Recruiting
        • Investigational Site Number: 8400012
      • Miami, Florida, United States, 33134
        • Recruiting
        • Investigational Site Number 8400028
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Investigational Site Number: 8400007
      • Palmetto Bay, Florida, United States, 33176
        • Recruiting
        • Investigational Site Number: 8400011
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Investigational Site Number: 8400019
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Investigational Site Number: 8400025
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Investigational Site Number: 8400006
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Investigational Site Number: 8400022
    • Michigan
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Investigational Site Number: 8400008
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Investigational Site Number: 8400013
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Investigational Site Number: 8400003
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Recruiting
        • Investigational Site Number: 8400009
    • Texas
      • Fredericksburg, Texas, United States, 78229
        • Recruiting
        • Investigational Site Number: 8400002
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Investigational Site Number: 8400016
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Investigational Site Number: 8400027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo
Drug: Placebo
Route of Administration: Subcutaneous
Experimental: SAR442970 Dose Regimen A
Participants will receive SAR442970 dose regimen A
Drug: SAR442970
Route of Administration: Subcutaneous
Experimental: SAR442970 Dose Regimen B
Participants will receive SAR442970 dose regimen B
Drug: SAR442970
Route of Administration: Subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who achieve endoscopic response at Week 16
Time Frame: From Baseline to Week 16
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
From Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
On-treatment serum concentrations of SAR442970 at predefined timepoints
Time Frame: Up to End of Study (approximately 164 weeks)
Up to End of Study (approximately 164 weeks)
Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period
Time Frame: Up to End of Study (approximately 164 weeks)
Up to End of Study (approximately 164 weeks)
Number and percentage of participants with any TEAEs during open-label treatment period
Time Frame: Up to Week 52
Up to Week 52
Incidence of Anti-drug Antibodies (ADAs) over time
Time Frame: Up to End of Study (approximately 164 weeks)
Up to End of Study (approximately 164 weeks)
Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16
Time Frame: At Week 16
CDAI clinical remission is defined as CDAI score <150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
At Week 16
Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16
Time Frame: At Week 16
PRO-2 clinical remission is defined as using the average daily Stool Frequency (SF) ≤3 and not worse than baseline and average daily AP ≤1 and not worse than baseline.
At Week 16
Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16
Time Frame: At Week 16
Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore >1 in any individual variable based on central reading.
At Week 16
Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16
Time Frame: At Week 16
CDAI clinical remission is defined as CDAI score <150, endoscopic response is defined as a decrease in SES-CD >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
At Week 16
Percentage of participants who achieve CDAI clinical response at Week 16
Time Frame: At Week 16
CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.
At Week 16
Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time Frame: From Baseline to Week 16
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item instrument assessing health-related quality of life in IBD patients across four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Each question evaluates experiences over the previous two weeks on a 7-point Likert scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224, with higher scores indicating better quality of life. Both domain-specific and overall scores can be calculated.
From Baseline to Week 16
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
Time Frame: From Baseline to Week 16
The FACIT-F questionnaire assesses fatigue associated with anemia through 13 fatigue-related questions. Each item is scored on a 5-point Likert scale (0="not at all" to 4="very much"), with total scores ranging from 0 to 52. High scores represent less fatigue. For Crohn's Disease patients, a 7-10 point improvement on the FACIT-F total score may represent meaningful improvements.
From Baseline to Week 16
Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 52
Time Frame: At Week 52
Endoscopic remission is defined as SES-CD ≤4 and at least 2 point reduction versus baseline and no subscore >1 in any individual variable based on central reading.
At Week 52
Percentage of participants achieving CDAI clinical remission at Week 52
Time Frame: At Week 52
CDAI clinical remission is defined as CDAI <150.
At Week 52
Percentage of participants achieving CDAI clinical remission at both Week 16 and at Week 52
Time Frame: At Week 52
CDAI clinical remission is defined as CDAI <150.
At Week 52
Percentage of participants who achieve endoscopic response at Week 52
Time Frame: At Week 52
Endoscopic response is defined as decrease in SES-CD >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
At Week 52
Percentage of participants who achieve endoscopic response at both Week 16 and Week 52
Time Frame: At Week 52
Endoscopic response is defined as decrease in SES-CD >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
At Week 52
Percentage of participants who achieve CDAI clinical response at Week 52
Time Frame: At Week 52
CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.
At Week 52
Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 52
Time Frame: At Week 52
CDAI clinical remission is defined as CDAI score <150, endoscopic response is defined as a decrease in SES-CD >50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading.
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

December 17, 2026

Study Completion (Estimated)

October 17, 2029

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI18450 (Other Identifier: Sanofi)
  • U1111-1306-7510 (Other Identifier: WHO)
  • 2024-517016-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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