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A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Led by Sanofi · Updated on 2026-04-23
99
Participants Needed
67
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years inclusive at informed consent
- Clinical evidence of active Ulcerative Colitis for at least 3 months before screening confirmed by endoscopy
- Active moderate-to-severe Ulcerative Colitis at screening defined by modified Mayo Score of 5 to 9 with specified subscores
- Prior treatment for Ulcerative Colitis with inadequate response, loss of response, or intolerance to standard treatments or at least one approved advanced therapy
- Use of contraception according to local regulations during study participation
You will not qualify if you...
- Active Crohn's Disease, indeterminate colitis, or microscopic colitis
- Positive stool test for aerobic pathogens or Clostridium difficile B toxin
- History of ostomy, ileoanal pouch, prior or planned colectomy during study
- Ongoing complications of Ulcerative Colitis such as fulminant disease, toxic megacolon, or colonic dysplasia (except adenoma)
- Intestinal failure or short bowel syndrome requiring total parenteral nutrition
- Recent serious infection or infections requiring hospitalization or certain anti-infective treatments
- Significant current immunosuppression, history of organ transplant, or splenectomy
- Moderate to severe congestive heart failure, recent cerebrovascular accident
- History of demyelinating disease or suggestive neurological symptoms
- History of malignancy or lymphoproliferative disease except certain localized carcinomas
- Diagnosis of inflammatory conditions other than Ulcerative Colitis
- History or positive test for HIV infection
- History of interstitial lung disease
- Positive hepatitis B or C markers at screening
- Abnormal screening laboratory or other test results
- Any other condition that may increase risk according to investigator judgement
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 67 locations
1
Investigational Site Number: 8400009
Escondido, California, United States, 92025
Actively Recruiting
2
Investigational Site Number: 8400006
Lancaster, California, United States, 93534
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3
Investigational Site Number: 8400025
Thousand Oaks, California, United States, 91360
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4
Investigational Site Number: 8400024
Jacksonville, Florida, United States, 32258
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5
Investigational Site Number: 8400030
Kissimmee, Florida, United States, 347441
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6
Investigational Site Number: 8400003
Lighthouse PT, Florida, United States, 33064
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7
Investigational Site Number: 8400001
Miami, Florida, United States, 33134
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8
Investigational Site Number: 8400011
Miami, Florida, United States, 33136
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9
Investigational Site Number: 8400010
Palmetto Bay, Florida, United States, 33176
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10
Investigational Site Number: 8400019
Tampa, Florida, United States, 33609
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11
Investigational Site Number: 8400018
Marietta, Georgia, United States, 30060
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12
Investigational Site Number: 8400005
Iowa City, Iowa, United States, 52242
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13
Investigational Site Number: 8400017
Boston, Massachusetts, United States, 02115
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14
Investigational Site Number: 8400012
Wyoming, Michigan, United States, 49519
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15
Investigational Site Number: 8400014
St Louis, Missouri, United States, 63110
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16
Investigational Site Number: 8400021
New York, New York, United States, 10029
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17
Investigational Site Number: 8400029
Queens Village, New York, United States, 11428
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18
Investigational Site Number: 8400002
Chapel Hill, North Carolina, United States, 27514
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19
Investigational Site Number: 8400013
Harrisburg, Pennsylvania, United States, 17110
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20
Investigational Site Number: 8400023
Houston, Texas, United States, 77030
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21
Investigational Site Number: 8400007
Ogden, Utah, United States, 84405
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22
Investigational Site Number: 0360003
Brisbane, Queensland, Australia, 4101
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23
Investigational Site Number: 0360001
Clayton, Victoria, Australia, 3168
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24
Investigational Site Number: 1560004
Huizhou, Ghangdong, China, 516001
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25
Investigational Site Number: 1560005
Guangzhou, Guangdong, China, 510655
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26
Investigational Site Number: 1560002
Nanjing, Jiangsu, China, 210029
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27
Investigational Site Number: 1560008
Suzhou, Jiangsu, China, 215006
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28
Investigational Site Number: 1560003
Wuxi, Jiangsu, China, 214023
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29
Investigational Site Number: 1560009
Shanghai, Shanghai Municipality, China, 200025
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30
Investigational Site Number: 1560001
Hangzhou, China, 310016
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31
Investigational Site Number: 1560007
Ningbo, China, 315010
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32
Investigational Site Number: 2030001
Brno, JM, Czechia, 61500
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33
Investigational Site Number: 2030002
Slaný, Czechia, 27401
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34
Investigational Site Number: 2500002
Lille, France, 59037
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35
Investigative Site: 2500006
Nice, France, 6200
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36
Investigational Site Number: 2500005
Pierre-Bénite, France, 69495
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37
Investigational Site Number: 2500001
Saint-Priest-en-Jarez, France, 42270
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38
Investigational Site Number: 2500003
Toulouse, France, 31400
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39
Investigational Site Number: 2500004
Vandœuvre-lès-Nancy, France, 54500
Withdrawn
40
Investigational Site Number: 2760001
Minden, Northwest, Germany, 32423
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41
Investigational Site Number: 2760005
Kiel, Schleswig-Holstein, Germany, 24105
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42
Investigational Site Number: 2760003
Ulm, Germany, 89081
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43
Investigational Site Number: 3480003
Budapest, Hungary, 1066
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44
Investigational Site Number: 3480002
Budapest, Hungary, 1088
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45
Investigational Site Number: 3480001
Vác, Hungary, 2600
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46
Investigational Site Number: 3920002
Kashiwa, Chiba, Japan, 277-0871
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47
Investigational Site Number: 3920006
Ōita, Oita Prefecture, Japan, 870-0033
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48
Investigational Site Number: 3920005
Hamamatsu, Japan, 431-3192
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49
Investigational Site Number: 3920003
Hirosaki, Japan, 036-8545
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50
Investigational Site Number: 3920001
Morioka, Japan, 020-8505
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51
Investigational Site Number: 3920004
Nishinomiya, Japan, 663-8501
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52
Investigational Site Number: 4980001
Chisinau, Moldova, 2025
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53
Investigational Site Number: 6160006
Wroclaw, Lower Silesian Voivodeship, Poland, 53-149
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54
Investigational Site Number: 6160002
Bydgoszcz, Poland, 85-229
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55
Investigational Site Number: 6160009
Chojnice, Poland, 89-600
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56
Investigational Site Number: 6160007
Katowice, Poland, 40-748
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57
Investigational Site Number: 6160005
Sopot, Poland, 81-756
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58
Investigational Site Number: 6160008
Tychy, Poland, 43-100
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59
Investigational Site Number: 6160004
Warsaw, Poland, 00-189
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60
Investigational Site Number: 6160003
Warsaw, Poland, 04-501
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61
Investigational Site Number: 6160001
Wroclaw, Poland, 52-210
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62
Investigational Site Number: 7240001
Las Palmas de Gran Canaria, Spain, 35010
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63
Investigational Site Number: 7240002
Madrid, Spain, 28046
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64
Investigational Site Number: 8260002
Northwich, CHW, United Kingdom, CW9 7LS
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65
Investigational Site Number: 8260003
Bury, United Kingdom, BL9 7TD
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66
Investigational Site Number: 8260001
London, United Kingdom, E11 1NR
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67
Investigational Site Number: 8260004
London, United Kingdom, SE1 7EH
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Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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