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Crohn's DiseasePhase 2CHROMA CDNCT06958536

A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease

A Phase 2 study testing brivekimig in people with Crohn's Disease, run by Sanofi at 66 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
brivekimig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
66 sitesin 12 countries
Study dates
3 Jun 2025to 17 Oct 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids 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, AZA, 6-MP, or 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

Who cannot join

  • 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
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  • 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 locations and contacts

66 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. Option 6

contact-us@sanofi.com

66 sites in 12 countries

United States20 sites, 19 recruiting

  • Investigational Site Number: 8400022

    Boston, Massachusetts, 02115

    Recruiting

  • Investigational Site Number: 8400003

    Chapel Hill, North Carolina, 27599

    Withdrawn

  • Investigational Site Number: 8400005

    Escondido, California, 92025

    Recruiting

  • Investigational Site Number: 8400002

    Fredericksburg, Texas, 78229

    Recruiting

  • Investigational Site Number: 8400009

    Harrisburg, Pennsylvania, 17110

    Recruiting

  • Investigational Site Number: 8400025

    Iowa City, Iowa, 52242

    Recruiting

  • Investigational Site Number: 8400006

    Kansas City, Kansas, 66160

    Recruiting

  • Investigational Site Number: 8400017

    Kissimmee, Florida, 34741

    Recruiting

  • Investigational Site Number: 8400001

    Lancaster, California, 93534

    Recruiting

  • Investigational Site Number: 8400015

    Lighthouse PT, Florida, 33064

    Recruiting

  • Investigational Site Number: 8400019

    Marietta, Georgia, 30060

    Recruiting

  • Investigational Site Number 8400028

    Miami, Florida, 33134

    Recruiting

  • Investigational Site Number: 8400012

    Miami, Florida, 33136

    Recruiting

  • Investigational Site Number: 8400016

    Ogden, Utah, 84405

    Recruiting

  • Investigational Site Number: 8400007

    Orlando, Florida, 32804

    Recruiting

  • Investigational Site Number: 8400011

    Palmetto Bay, Florida, 33176

    Recruiting

  • Investigational Site Number: 8400027

    Richmond, Virginia, 23249

    Recruiting

  • Investigational Site Number: 8400013

    St Louis, Missouri, 63110

    Recruiting

  • Investigational Site Number: 8400024

    Tucson, Arizona, 85724

    Recruiting

  • Investigational Site Number: 8400008

    Wyoming, Michigan, 49519

    Recruiting

Other trials in United States

China8 sites, 8 recruiting

  • Investigative Site: 1560003

    Changsha, 410011

    Recruiting

  • Investigational Site Number: 1560008

    Changsha, 410013

    Recruiting

  • Investigative Site: 1560005

    Changzhou, 213003

    Recruiting

  • Investigational Site Number: 1560001

    Guangzhou, 510655

    Recruiting

  • Investigational Site Number: 1560006

    Hangzhou, 310009

    Recruiting

  • Investigative Site: 1560004

    Nanchang, 330006

    Recruiting

  • Investigative Site: 1560002

    Shanghai, 200092

    Recruiting

  • Investigational Site Number: 1560007

    Shenyang, 110004

    Recruiting

Other trials in China

Japan8 sites, 8 recruiting

  • Investigational Site Number: 3920004

    Bunkyō City, 113-8519

    Recruiting

  • Investigational Site Number: 3920006

    Hamamatsu, Shizuoka, 432-8061

    Recruiting

  • Investigational Site Number: 3920003

    Hamamatsu, 431-3192

    Recruiting

  • Investigational Site Number: 3920009

    Hirosaki, 036-8545

    Recruiting

  • Investigational Site Number: 3920007

    Kashiwa, Chiba, 277-0871

    Recruiting

  • Investigational Site Number: 3920001

    Morioka, 020-8505

    Recruiting

  • Investigational Site Number: 3920002

    Nishinomiya, 663-8501

    Recruiting

  • Investigational Site Number: 3920005

    Ōita, Oita Prefecture, 870-0033

    Recruiting

Other trials in Japan

Poland7 sites, 7 recruiting

  • Investigational Site Number: 6160001

    Krakow, 31-501

    Recruiting

  • Investigational Site Number: 6160005

    Lublin, 20-582

    Recruiting

  • Investigational Site Number: 6160006

    Sopot, 81-756

    Recruiting

  • Investigational Site Number: 6160008

    Warsaw, 00-189

    Recruiting

  • Investigational Site Number: 6160003

    Warsaw, 01-783

    Recruiting

  • Investigational Site Number: 6160002

    Wroclaw, Lower Silesian Voivodeship, 53-149

    Recruiting

  • Investigational Site Number: 6160004

    Wroclaw, 54-206

    Recruiting

Other trials in Poland

United Kingdom5 sites, 5 recruiting

  • Investigational Site Number: 8260007

    Bury, BL9 7TD

    Recruiting

  • Investigational Site Number: 8260004

    Cambridge, CB2 0QQ

    Recruiting

  • Investigational Site Number: 8260005

    London, E11 1NR

    Recruiting

  • Investigational Site Number: 8260002

    London, HA8 0AD

    Recruiting

  • Investigational Site Number: 8260001

    London, SE1 7EH

    Recruiting

Other trials in United Kingdom

Germany4 sites, 3 recruiting

  • Investigational Site Number: 2760003

    Jena, 07747

    Completed

  • Investigational Site Number: 2760004

    Kiel, 24105

    Recruiting

  • Investigational Site Number: 2760002

    Minden, Northwest, 32423

    Recruiting

  • Investigational Site Number: 2760001

    Ulm, 89081

    Recruiting

Other trials in Germany

Australia3 sites, 3 recruiting

  • Investigational Site Number: 0360002

    Brisbane, Queensland, 4101

    Recruiting

  • Investigational Site Number: 0360001

    Footscray, 3011

    Recruiting

  • Investigational Site Number: 0360004

    Kurralta Park, South Australia, 5037

    Recruiting

Other trials in Australia

Czechia3 sites, 3 recruiting

  • Investigational Site Number: 2030002

    Brno, JM, 61500

    Recruiting

  • Investigational Site Number: 2030003

    Hradec Králové, 50012

    Recruiting

  • Investigational Site Number: 2030005

    Slaný, 274 01

    Recruiting

Other trials in Czechia

France3 sites, 3 recruiting

  • Investigational Site Number: 2500001

    Montpellier, 34090

    Recruiting

  • Investigational Site Number: 2500003

    Nice, 6000

    Recruiting

  • Investigational Site Number: 2500002

    Toulouse, 31059

    Recruiting

Other trials in France

Spain3 sites, 3 recruiting

  • Investigational Site Number: 7240002

    Madrid, 28003

    Recruiting

  • Investigational Site Number: 7240001

    Madrid, 28046

    Recruiting

  • Investigational Site Number: 7240003

    Seville, 41009

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • Investigational Site Number: 0560001

    Leuven, B-3000

    Recruiting

Other trials in Belgium

South Africa1 site, 1 recruiting

  • Investigational Site Number: 7100003

    Johannesburg, 1619

    Recruiting

Other trials in South Africa

About this study

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

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, 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.

Conditions
Crohn's Disease
Being tested
brivekimig, Placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brivekimigDrug

    Also called SAR442970

    Route of Administration: Subcutaneous

  • PlaceboDrug

    Route of Administration: Subcutaneous

Study groups in NCT06958536
Study groupRoleWhat they receive
Brivekimig Dose Regimen AExperimentalParticipants will receive brivekimig dose regimen A
Receives: Drug: brivekimig
Brivekimig Dose Regimen BExperimentalParticipants will receive brivekimig dose regimen B
Receives: Drug: brivekimig
PlaceboPlacebo comparatorParticipants will receive placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who achieve endoscopic response at 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.

    Measured: From Baseline to Week 16

Secondary outcomes (13)

  1. Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) 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.

    Measured: At Week 16

  2. Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission 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.

    Measured: At Week 16

  3. Percentage of participants who achieve endoscopic remission based on centrally read SES-CD 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.

    Measured: At Week 16

  4. Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD 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.

    Measured: At Week 16

  5. Percentage of participants who achieve CDAI clinical response at Week 16

    CDAI clinical response is defined as reduction of CDAI ≥100 points from baseline.

    Measured: At Week 16

  6. Change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) score

    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.

    Measured: From Baseline to Week 16

  7. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score

    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.

    Measured: From Baseline to Week 16

  8. On-treatment serum concentrations of brivekimig at predefined timepoints

    Measured: Up to End of Study (approximately 164 weeks)

  9. Number and percentage of participants with any Treatment Emergent Adverse Events (TEAEs) during induction, maintenance and Long-term Extension (LTE) treatment period

    Measured: Up to End of Study (approximately 164 weeks)

  10. Number and percentage of participants with any TEAEs during open-label treatment period

    Measured: Up to Week 52

  11. Incidence of Anti-drug Antibodies (ADAs) over time

    Measured: Up to End of Study (approximately 164 weeks)

  12. Percentage of participants who achieve endoscopic remission based on centrally read SES-CD 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.

    Measured: At Week 52

  13. Percentage of participants who achieve endoscopic response 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.

    Measured: At Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start3 Jun 2025
  3. Primary completion17 Dec 2026 (estimated)
  4. Study completion17 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958536
Sponsor's protocol ID
DRI18450
Other IDs
U1111-1306-7510, 2024-517016-30-00, DRI18450
Acronym
CHROMA CD
Status last verified
Oct 2026
First submitted
25 Apr 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brivekimig in people with Crohn's Disease, run by Sanofi at 66 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, China, Japan, Poland, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. Option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who achieve endoscopic response at Week 16 (time frame: From Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06958536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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