NCT06975722 · Sanofi
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
(COLOR UC)
What this study is about
This is a phase 2b, randomly assigned, where neither patients nor doctors know which treatment is given, 3-treatment group$1 study for the treatment of Ulcerative Colitis. The primary objective of this study is to assess the effectiveness of different doses of SAR442970 compared with placebo in participants with moderate to severe Ulcerative Colitis.
View original scientific description
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.
Interventions
DRUG
SAR442970
Route of administration: Subcutaneous
DRUG
Placebo
Route of administration: Subcutaneous
Primary outcome measures
Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)
Time frame: At Week 16
Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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, a minimum sum of all subscores of 5, 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): 1. History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, co
Where
- Escondido, California
- Lancaster, California
- Thousand Oaks, California
- Jacksonville, Florida
- Kissimmee, Florida
- Lighthouse PT, Florida
- Miami, Florida
- Palmetto Bay, Florida
- Tampa, Florida
- Marietta, Georgia
- Iowa City, Iowa
- Boston, Massachusetts
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations