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Ulcerative ColitisPhase 2COLOR UCNCT06975722

A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis

A Phase 2 study testing SAR442970 in people with Ulcerative Colitis, run by Sanofi at 69 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
SAR442970
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
69 sitesin 12 countries
Study dates
7 Jul 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

  • Participants are eligible to be included in the study only if all of the following criteria apply:
  • Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
  • Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
  • Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimum Rectal Bleeding (RB) subscore ≥1, a minimum Stool Frequency (SF) subscore ≥1, mMES ≥2 confirmed by central reader and a minimum disease extent of 15 cm from the anal verge
  • Must have received prior treatment for UC (either "a" or "b" below or combination of both):
  • History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to approved Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC
  • History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat UC
  • 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 are excluded from the study if any of the following criteria apply:
  • Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis
  • Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
  • Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
  • Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
  • Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
Show all 22Show fewer
  • History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimen
  • Known history of or suspected significant current immunosuppression.
  • History or solid organ transplant or splenectomy
  • History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.
  • History of demyelinating disease (including myelitis), family history of demyelinating disease, or neurologic symptoms suggestive of demyelinating disease
  • Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
  • Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.)
  • History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening
  • History of Interstitial Lung Disease
  • Participants with any of the following results at Screening:
  • Positive Hepatitis B surface antigen (HBs Ag) or,
  • Positive total Hepatitis B core antibody (anti-HBcAB)
  • Positive Hepatitis C Virus (HCV) antibody confirmed by positive HCV Ribonucleic Acid (RNA) (participants with HCV antibody (HCVAb) and negative HCV RNA may be included).
  • Screening laboratory and other analyses showing abnormal results
  • History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

69 sites in 12 countries.

69 sites in 12 countries

United States21 sites

  • Investigational Site Number: 8400017

    Boston, Massachusetts, 02115

  • Investigational Site Number: 8400009

    Escondido, California, 92025

  • Investigational Site Number: 8400027

    Fairhope, Alabama, 36532

  • Investigational Site Number: 8400023

    Houston, Texas, 77030

  • Investigational Site Number: 8400005

    Iowa City, Iowa, 52242

  • Investigational Site Number: 8400024

    Jacksonville, Florida, 32258

  • Investigational Site Number: 8400028

    Kansas City, Kansas, 66160

  • Investigational Site Number: 8400030

    Kissimmee, Florida, 347441

  • Investigational Site Number: 8400006

    Lancaster, California, 93534

  • Investigational Site Number: 8400003

    Lighthouse PT, Florida, 33064

  • Investigational Site Number: 8400018

    Marietta, Georgia, 30060

  • Investigational Site Number: 8400001

    Miami, Florida, 33134

  • Investigational Site Number: 8400011

    Miami, Florida, 33136

  • Investigational Site Number: 8400021

    New York, New York, 10029

  • Investigational Site Number: 8400007

    Ogden, Utah, 84405

  • Investigational Site Number: 8400010

    Palmetto Bay, Florida, 33176

  • Investigational Site Number: 8400029

    Queens Village, New York, 11428

  • Investigational Site Number: 8400014

    St Louis, Missouri, 63110

  • Investigational Site Number: 8400019

    Tampa, Florida, 33609

  • Investigational Site Number: 8400025

    Thousand Oaks, California, 91360

  • Investigational Site Number: 8400012

    Wyoming, Michigan, 49519

Other trials in United States

Poland9 sites

  • Investigational Site Number: 6160002

    Bydgoszcz, 85-229

  • Investigational Site Number: 6160009

    Chojnice, 89-600

  • Investigational Site Number: 6160007

    Katowice, 40-748

  • Investigational Site Number: 6160005

    Sopot, 81-756

  • Investigational Site Number: 6160008

    Tychy, 43-100

  • Investigational Site Number: 6160004

    Warsaw, 00-189

  • Investigational Site Number: 6160003

    Warsaw, 04-501

  • Investigational Site Number: 6160006

    Wroclaw, Lower Silesian Voivodeship, 53-149

  • Investigational Site Number: 6160001

    Wroclaw, 52-210

Other trials in Poland

China8 sites

  • Investigational Site Number: 1560005

    Guangzhou, Guangdong, 510655

  • Investigational Site Number: 1560001

    Hangzhou, 310016

  • Investigational Site Number: 1560004

    Huizhou, Ghangdong, 516001

  • Investigational Site Number: 1560002

    Nanjing, Jiangsu, 210029

  • Investigational Site Number: 1560007

    Ningbo, 315010

  • Investigational Site Number: 1560009

    Shanghai, Shanghai Municipality, 200025

  • Investigational Site Number: 1560008

    Suzhou, Jiangsu, 215006

  • Investigational Site Number: 1560003

    Wuxi, Jiangsu, 214023

Other trials in China

Japan6 sites

  • Investigational Site Number: 3920005

    Hamamatsu, 431-3192

  • Investigational Site Number: 3920003

    Hirosaki, 036-8545

  • Investigational Site Number: 3920002

    Kashiwa, Chiba, 277-0871

  • Investigational Site Number: 3920001

    Morioka, 020-8505

  • Investigational Site Number: 3920004

    Nishinomiya, 663-8501

  • Investigational Site Number: 3920006

    Ōita, Oita Prefecture, 870-0033

Other trials in Japan

France5 sites

  • Investigational Site Number: 2500002

    Lille, 59037

  • Investigational Site Number: 2500007

    Montpellier, 34090

  • Investigational Site Number: 2500006

    Nice, 6200

  • Investigational Site Number: 2500005

    Pierre-Bénite, 69495

  • Investigational Site Number: 2500001

    Saint-Priest-en-Jarez, 42270

Other trials in France

United Kingdom5 sites

  • Investigational Site Number: 8260003

    Bury, BL9 7TD

  • Investigational Site Number: 8260005

    Cambridge, CB2 0QQ

  • Investigational Site Number: 8260001

    London, E11 1NR

  • Investigational Site Number: 8260004

    London, SE1 7EH

  • Investigational Site Number: 8260002

    Northwich, CHW, CW9 7LS

Other trials in United Kingdom

Australia3 sites

  • Investigational Site Number: 0360003

    Brisbane, Queensland, 4101

  • Investigational Site Number: 0360001

    Clayton, Victoria, 3168

  • Investigational Site Number: 360002

    Murdoch, 6150

Other trials in Australia

Germany3 sites

  • Investigational Site Number: 2760005

    Kiel, Schleswig-Holstein, 24105

  • Investigational Site Number: 2760001

    Minden, Northwest, 32423

  • Investigational Site Number: 2760003

    Ulm, 89081

Other trials in Germany

Hungary3 sites

  • Investigational Site Number: 3480003

    Budapest, 1066

  • Investigational Site Number: 3480002

    Budapest, 1088

  • Investigational Site Number: 3480001

    Vác, 2600

Other trials in Hungary

Spain3 sites

  • Investigational Site Number: 7240003

    Barcelona, 8022

  • Investigational Site Number: 7240001

    Las Palmas de Gran Canaria, 35010

  • Investigational Site Number: 7240002

    Madrid, 28046

Other trials in Spain

Czechia2 sites

  • Investigational Site Number: 2030001

    Brno, JM, 61500

  • Investigational Site Number: 2030002

    Slaný, 27401

Other trials in Czechia

Moldova1 site

  • Investigational Site Number: 4980001

    Chisinau, 2025

Other trials in Moldova

About this study

Official title: A Phase 2b, Multi-national, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Followed by a Long-term Extension to Evaluate the Efficacy and Safety of Brivekimig in Adult Participants With Moderate to Severe Ulcerative Colitis

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.

Being tested
SAR442970, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • SAR442970Drug

    Also called brivekimig

    Route of administration: Subcutaneous

  • PlaceboDrug

    Route of administration: Subcutaneous

Study groups in NCT06975722
Study groupRoleWhat they receive
SAR442970 Dose Regimen AExperimentalParticipants will receive SAR442970 dose regimen A
Receives: Drug: SAR442970
SAR442970 Dose Regimen BExperimentalParticipants will receive SAR442970 dose regimen B
Receives: Drug: SAR442970; Drug: Placebo
PlaceboPlacebo comparatorParticipants will receive SAR442970-matching placebo
Receives: Drug: Placebo

What is being measured

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

  1. Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)

    Clinical remission is defined as a mMS of 0 to 2, including Stool Frequency (SF) subscore of 0 or 1, Rectal Bleeding (RB) subscore of 0 and modified Mayo Endoscopic (mMES) of 0 or 1 confirmed by central reader (score of 1 does not include friability)

    Measured: At Week 16

Secondary outcomes (13)

  1. Proportion of participants who achieve endoscopic improvement at Week 16

    Endoscopic improvement is defined as an mMES of 0 or 1 (where 1 does not include friability).

    Measured: At Week 16

  2. Proportion of participants who achieve endoscopic response at Week 16

    Endoscopic response is defined as an mMES decrease of at least 1.

    Measured: At Week 16

  3. Proportion of participants who achieve endoscopic remission at Week 16

    Endoscopic remission is defined as an mMES of 0, confirmed by central reader

    Measured: At Week 16

  4. Proportion of participants who achieve endoscopic improvement at Week 52

    Endoscopic improvement is defined as an mMES of 0 or 1 (where 1 does not include friability). The mMES ranges from 0 to 3 with higher scores indicating greater disease severity.

    Measured: At Week 52

  5. Proportion of participants who achieve clinical remission by total Mayo Score (MS) at Week 16

    Clinical remission (total MS) is defined as total MS ≤2 with no individual subscore >1.

    Measured: At Week 16

  6. Proportion of participants who achieve clinical response at Week 16 by total MS

    Clinical response by total MS is defined as a decrease from baseline in the total MS of ≥3 points and at least 30% reduction from baseline, and a decrease in the RB subscore of ≥1 or an absolute RB subscore of 0 or 1.

    Measured: At Week 16

  7. Proportion of participants who achieve clinical response at Week 16 by mMS

    Clinical response by mMS is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in RB subscore ≥1 or an absolute RB subscore ≤1.

    Measured: At Week 16

  8. Proportion of participants who achieve clinical remission at Week 52 by mMS

    Clinical remission is defined as an mMS score of 0 to 2, including SF subscore of 0 or 1, RB subscore of 0, and mMES of 0 or 1 (score of 1 does not include friability).

    Measured: At Week 52

  9. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

    This captures the patient's experience of inflammatory bowel disease (IBD) on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. 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

  10. Serum brivekimig concentrations

    Measured: Up to end of study (approximately 164 weeks)

  11. Incidence of Anti-drug Antibodies (ADAs)

    Measured: Up to end of study (approximately 164 weeks)

  12. Number (percentage) of participants with any Treatment Emergent Adverse Events (TEAEs) during the Induction and Maintenance treatment periods

    Measured: From start of induction period to Week 52

  13. Number (percentage) of participants with any TEAEs during the Long-term Extension (LTE) period

    Measured: From Week 52 (start of LTE period) up to end of the study (approximately 164 weeks)

Timeline

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

  1. First posted16 May 2025
  2. Study start7 Jul 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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06975722
Sponsor's protocol ID
ACT18134
Other IDs
2024-515241-41-00, U1111-1305-7281, ACT18134
Acronym
COLOR UC
Status last verified
Oct 2026
First submitted
28 Apr 2025
Last updated
2 Nov 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 SAR442970 in people with Ulcerative Colitis, run by Sanofi at 69 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 8 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Poland, China, Japan, France 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) (time frame: At 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 NCT06975722.

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 2 Nov 2026.

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