Actively Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating SAR441566 in Adults with Moderate-to-severe Ulcerative Colitis
Led by Sanofi · Updated on 2026-05-28
204
Participants Needed
115
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SAR441566 in adults aged 18 to 75 years with moderate-to-severe ulcerative colitis (UC) in this Phase 2 multinational, randomized, double-blind, placebo-controlled study. The main goal is to assess how different doses of SAR441566 affect clinical remission in participants with active UC. The study includes a screening period of up to 28 days plus an additional 7 days if needed. Participants will receive one of three dose regimens of SAR441566 or a matching placebo, given orally as tablets. The study treatment period lasts up to 52 weeks, with a 12-week induction phase followed by a 40-week maintenance phase and a 2-week follow-up after treatment ends. An optional open-label period of up to 40 weeks is also offered to eligible participants not enrolling in a long-term safety study. During the study, participants will attend 12 visits in the main treatment period and up to 8 visits during the open-label phase. Researchers will monitor clinical remission using the modified Mayo Score at week 12 and evaluate other outcomes such as clinical response, endoscopic remission, patient-reported outcomes, and adverse events. Safety will be closely followed throughout the study, which may last up to 59 weeks in total for each participant.
CONDITIONS
Brief Title
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years
- Clinical evidence of active ulcerative colitis for at least 3 months confirmed by endoscopy
- Moderate-to-severe ulcerative colitis at screening defined by modified Mayo Score 5 to 9 with specific subscore requirements
- Prior treatment for ulcerative colitis with either standard therapies or approved advanced therapies
- Use of contraception consistent with local regulations for participants of childbearing potential
You will not qualify if you...
- Diagnosis of active Crohn's disease, indeterminate colitis, ischemic colitis, or microscopic colitis
- Complications such as fulminant colitis, toxic megacolon, or conditions requiring bowel surgery during the study
- Prior colectomy, ostomy, ileoanal pouch, or anticipated colectomy during participation
- Positive tests for ova, parasites, bacterial pathogens, or Clostridium difficile toxin in stool
- Active tuberculosis or incompletely treated latent tuberculosis
- Positive hepatitis B surface antigen or core antibody, or hepatitis C virus antibody
- Active, chronic, or recurrent infections including herpes zoster or herpes simplex
- Known HIV infection or positive HIV serology
- Active malignancies or lymphoproliferative disease within 5 years prior to screening
- Gastrointestinal dysplasia not completely removed or presence of adenomatous polyps not removed by screening
- Pregnancy, breastfeeding, or planning pregnancy during study and 3 months post last dose
- Recent treatment with IV or oral anti-infectives within specified timeframes
- Use of parenteral nutrition or exclusive enteral nutrition
- Recent use of cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, fecal microbial transplantation, or IV corticosteroids
- Exposure to natalizumab or oral carotegrast methyl
- Abnormal laboratory or screening results preventing safe participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive one of three dose regimens of SAR441566 or a matching placebo to treat moderate-to-severe ulcerative colitis.
Weekly visits for up to 12 weeks
Duration - Up to 40 weeks
Participants are monitored for safety and plasma drug concentrations after the initial 12-week treatment period.
Visits at selected timepoints up to Week 52
Trial Site Locations
Total: 115 locations
1
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
Sun City, Arizona, United States, 85351
Actively Recruiting
2
Bristol Hospital- Site Number : 8400017
Bristol, Connecticut, United States, 06010
Actively Recruiting
3
Novum Research- Site Number : 8400018
Clermont, Florida, United States, 34711
Actively Recruiting
4
Clinical Research of Osceola- Site Number : 8400012
Kissimmee, Florida, United States, 34741
Actively Recruiting
5
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
Miami Lakes, Florida, United States, 33016
Actively Recruiting
6
GCP Clinical Research- Site Number : 8400016
Tampa, Florida, United States, 33609
Actively Recruiting
7
GI Alliance - Glenview- Site Number : 8400005
Glenview, Illinois, United States, 60026
Actively Recruiting
8
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee, Illinois, United States, 60031
Actively Recruiting
9
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai- Site Number : 8400001
New York, New York, United States, 10029
Actively Recruiting
11
Queens Village Primary Medical Center- Site Number : 8400011
Queens Village, New York, United States, 11428
Actively Recruiting
12
NexGen Research- Site Number : 8400020
Lima, Ohio, United States, 45805
Actively Recruiting
13
Frontier Clinical Research - Uniontown- Site Number : 8400006
Uniontown, Pennsylvania, United States, 15401
Actively Recruiting
14
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
Charleston, South Carolina, United States, 29401
Actively Recruiting
15
Gastro Health & Nutrition- Site Number : 8400007
Katy, Texas, United States, 77494
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16
SI Research Associates- Site Number : 8400019
Lubbock, Texas, United States, 79424
Actively Recruiting
17
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
Southlake, Texas, United States, 76092
Actively Recruiting
18
University of Washington Medical Center- Site Number : 8400014
Seattle, Washington, United States, 98195
Actively Recruiting
19
Washington Gastroenterology - Tacoma- Site Number : 8400009
Tacoma, Washington, United States, 98405
Actively Recruiting
20
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
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21
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1006
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22
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1023
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23
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1061
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24
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1125
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25
Investigational Site Number : 0360003
Kurralta Park, South Australia, Australia, 5037
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26
Investigational Site Number : 0400003
Graz, Austria, 8036
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27
Investigational Site Number : 0400002
Salzburg, Austria, 5020
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28
Investigational Site Number : 0400001
Vienna, Austria, 1090
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29
Investigational Site Number : 0560002
Ghent, Belgium, 9000
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30
Investigational Site Number : 0560001
Leuven, Belgium, 3000
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31
Hospital de Clinicas de Porto Alegre- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
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32
Hospital Ernesto Dornelles- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
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33
Investigational Site Number : 1000001
Burgas, Bulgaria, 8000
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34
Investigational Site Number : 1000003
Rousse, Bulgaria, 7002
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35
Investigational Site Number : 1000002
Sofia, Bulgaria, 1612
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36
Investigational Site Number : 1240004
Kentville, Nova Scotia, Canada, B4N 0A3
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37
Investigational Site Number : 1240005
Richmond Hill, Ontario, Canada, L4C 9M7
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38
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1N 4V3
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39
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 7500010
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40
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 8330034
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41
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8331143
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42
Investigational Site Number : 1560002
Guangzhou, China, 510655
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43
Investigational Site Number : 1560001
Hangzhou, China, 310016
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44
Investigational Site Number : 1560003
Huizhou, China, 516001
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45
Investigational Site Number : 1560017
Huizhou, China, 516001
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46
Investigational Site Number : 1560004
Jiazhuang, China, 050000
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47
Investigational Site Number : 1560014
Linhai, China, 317000
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48
Investigational Site Number : 1560008
Luoyang, China, 471003
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49
Investigational Site Number : 1560005
Shanghai, China, 200120
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50
Investigational Site Number : 1560007
Shanghai, China, 200127
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51
Investigational Site Number : 1560011
Wuhan, China, 430014
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52
Investigational Site Number : 2030001
Olomouc, Czechia, 779 00
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53
Investigational Site Number : 2030002
Ostrava, Czechia, 710 00
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54
Investigational Site Number : 2500003
Nice, France, 06202
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55
Investigational Site Number : 2500001
Toulouse, France, 31059
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56
Investigational Site Number : 2500002
Vandœuvre-lès-Nancy, France, 54511
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57
Investigational Site Number : 2680002
Tbilisi, Georgia, 0144
Actively Recruiting
58
Investigational Site Number : 2680003
Tbilisi, Georgia, 0160
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59
Investigational Site Number : 2680001
Tbilisi, Georgia, 0180
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60
Investigational Site Number : 2760005
Berlin, Germany, 10117
Actively Recruiting
61
Investigational Site Number : 2760008
Berlin, Germany, 14050
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62
Investigational Site Number : 2760010
Duisburg, Germany, 47055
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63
Investigational Site Number : 2760009
Frankfurt, Germany, 60590
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64
Investigational Site Number : 2760003
Hanover, Germany, 30625
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65
Investigational Site Number : 2760011
Tübingen, Germany, 72076
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66
Investigational Site Number : 2760006
Ulm, Germany, 89081
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67
Investigational Site Number : 3000001
Athens, Greece, 106 76
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68
Investigational Site Number : 3000003
Athens, Greece, 124 62
Actively Recruiting
69
Investigational Site Number : 3000002
Heraklion, Greece, 711 10
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70
Investigational Site Number : 3480001
Budapest, Hungary, 1085
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71
Investigational Site Number : 3560005
Hyderabad, India, 500082
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72
Investigational Site Number : 3560003
Jaipur, India, 302001
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73
Investigational Site Number : 3560009
Jaipur, India, 302004
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74
Investigational Site Number : 3560002
Kolkata, India, 700020
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75
Investigational Site Number : 3560004
Ludhiana, India, 141002
Actively Recruiting
76
Investigational Site Number : 3560007
Secunderabad, India, 500003
Actively Recruiting
77
Investigational Site Number : 3560001
Surat, India, 395002
Active, Not Recruiting
78
Investigational Site Number : 3560010
Visakhapatnam, India, 530040
Actively Recruiting
79
Investigational Site Number : 3800006
Genoa, Genova, Italy, 16132
Actively Recruiting
80
Investigational Site Number : 3800002
Milan, Milano, Italy, 20132
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81
Investigational Site Number : 3800003
Rozzano, Milano, Italy, 20089
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82
Investigational Site Number : 3800008
Naples, Napoli, Italy, 80131
Actively Recruiting
83
Investigational Site Number : 3800001
Padua, Padova, Italy, 35128
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84
Investigational Site Number : 3800011
Rome, Roma, Italy, 00161
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85
Investigational Site Number : 3800010
Turin, Torino, Italy, 10126
Actively Recruiting
86
Investigational Site Number : 3800007
Alessandria, Italy, 15100
Actively Recruiting
87
Investigational Site Number : 3800009
Palermo, Italy, 90127
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88
Investigational Site Number : 3800004
Pisa, Italy, 56124
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89
Investigational Site Number : 3920005
Kashiwa, Chiba, Japan, 277-0871
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90
Investigational Site Number : 3920014
Kure, Hiroshima, Japan, 737-0811
Actively Recruiting
91
Investigational Site Number : 3920003
Sapporo, Hokkaido, Japan, 004-0041
Actively Recruiting
92
Investigational Site Number : 3920007
Sapporo, Hokkaido, Japan, 065-0033
Actively Recruiting
93
Investigational Site Number : 3920009
Yahaba, Iwate, Japan, 028-3695
Actively Recruiting
94
Investigational Site Number : 3920013
Yokohama, Kanagawa, Japan, 220-0041
Actively Recruiting
95
Investigational Site Number : 3920002
Bunkyo, Tokyo, Japan, 113-8510
Actively Recruiting
96
Investigational Site Number : 3920011
Kodaira, Tokyo, Japan, 187-8510
Actively Recruiting
97
Investigational Site Number : 3920006
Kofu, Yamanashi, Japan, 400-0027
Actively Recruiting
98
Investigational Site Number : 3920012
Hiroshima, Japan, 734-0004
Actively Recruiting
99
Investigational Site Number : 3920016
Kagoshima, Japan, 892-0843
Actively Recruiting
100
Investigational Site Number : 3920001
Niigata, Japan, 950-1104
Actively Recruiting
101
Investigational Site Number : 3920010
Osaka, Japan, 530-0011
Completed
102
Investigational Site Number : 3920015
Tokyo, Japan, 108-8642
Actively Recruiting
103
Investigational Site Number : 6160008
Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
Actively Recruiting
104
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, Poland, 50-750
Actively Recruiting
105
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland, 03-580
Actively Recruiting
106
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 04-501
Actively Recruiting
107
Investigational Site Number : 6160002
Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
Actively Recruiting
108
Investigational Site Number : 7100002
Cape Town, South Africa, 7405
Actively Recruiting
109
Investigational Site Number : 7100001
Cape Town, South Africa, 7708
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110
Investigational Site Number : 7100004
KwaDukuza, South Africa, 4449
Actively Recruiting
111
Investigational Site Number : 7100003
Pretoria, South Africa, 0002
Actively Recruiting
112
Investigational Site Number : 7100005
Pretoria, South Africa, 0157
Actively Recruiting
113
Investigational Site Number : 7920002
Istanbul, Turkey (Türkiye), 34899
Actively Recruiting
114
Investigational Site Number : 7920003
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
115
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye), 33070
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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