Actively Recruiting
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
Led by Sanofi · Updated on 2026-04-28
204
Participants Needed
115
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
CONDITIONS
Official 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 inclusive at the time of signing informed consent
- Clinical evidence of active ulcerative colitis for at least 3 months before screening, confirmed by endoscopy
- Moderate-to-severe active ulcerative colitis at screening defined by a modified Mayo Score of 5 to 9 with specific subscore requirements and disease extent greater than 15 cm from the anal verge
- Prior treatment for ulcerative colitis including either inadequate response or intolerance to standard treatments (5-ASA, thiopurines, methotrexate, corticosteroids) or to at least one approved advanced therapy (biologics or small molecules)
- Use of contraception consistent with local regulations for men and women participating in clinical studies
You will not qualify if you...
- Presence of active Crohn's disease, indeterminate colitis, ischemic colitis, or microscopic colitis
- Known complications of ulcerative colitis requiring or likely to require bowel surgery during the study (e.g., fulminant colitis, toxic megacolon)
- Prior colectomy, ostomy, ileoanal pouch, or planned colectomy during study participation
- Positive fecal tests for ova, parasites, bacterial pathogens, or Clostridium difficile toxin
- Active or incompletely treated tuberculosis or latent tuberculosis infection
- Positive hepatitis B surface antigen or core antibody, or hepatitis C antibody
- Active, chronic, or recurrent infections including herpes zoster or herpes simplex
- Known HIV infection or positive HIV serology
- Active malignancy, lymphoproliferative disease, or recurrence within 5 years prior to screening
- Gastrointestinal dysplasia not completely removed or presence of colonic mucosal dysplasia or unresected adenomatous polyps
- For extensive colitis 8 years or more, or left-sided colitis over 10 years, colonoscopy within 1 year required; exclusion if dysplasia or cancer found
- Pregnancy, breastfeeding, or intention to become pregnant during or within 3 months after the study
- Recent infections requiring intravenous or oral anti-infectives within 30 or 14 days respectively prior to screening
- Need for or use of parenteral or exclusive enteral nutrition
- Recent use of cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, or fecal microbial transplantation
- Prior exposure to natalizumab or oral carotegrast methyl
- Recent intravenous corticosteroids within 14 days prior to or during screening
- Abnormal screening laboratory or other analysis results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
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
Actively Recruiting
21
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1006
Actively Recruiting
22
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1023
Actively Recruiting
23
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1061
Actively Recruiting
24
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1125
Actively Recruiting
25
Investigational Site Number : 0360003
Kurralta Park, South Australia, Australia, 5037
Actively Recruiting
26
Investigational Site Number : 0400003
Graz, Austria, 8036
Actively Recruiting
27
Investigational Site Number : 0400002
Salzburg, Austria, 5020
Actively Recruiting
28
Investigational Site Number : 0400001
Vienna, Austria, 1090
Actively Recruiting
29
Investigational Site Number : 0560002
Ghent, Belgium, 9000
Actively Recruiting
30
Investigational Site Number : 0560001
Leuven, Belgium, 3000
Actively Recruiting
31
Hospital de Clinicas de Porto Alegre- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Actively Recruiting
32
Hospital Ernesto Dornelles- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
Actively Recruiting
33
Investigational Site Number : 1000001
Burgas, Bulgaria, 8000
Actively Recruiting
34
Investigational Site Number : 1000003
Rousse, Bulgaria, 7002
Actively Recruiting
35
Investigational Site Number : 1000002
Sofia, Bulgaria, 1612
Actively Recruiting
36
Investigational Site Number : 1240004
Kentville, Nova Scotia, Canada, B4N 0A3
Actively Recruiting
37
Investigational Site Number : 1240005
Richmond Hill, Ontario, Canada, L4C 9M7
Actively Recruiting
38
Investigational Site Number : 1240001
Québec, Quebec, Canada, G1N 4V3
Actively Recruiting
39
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile, 7500010
Actively Recruiting
40
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 8330034
Actively Recruiting
41
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8331143
Actively Recruiting
42
Investigational Site Number : 1560002
Guangzhou, China, 510655
Actively Recruiting
43
Investigational Site Number : 1560001
Hangzhou, China, 310016
Actively Recruiting
44
Investigational Site Number : 1560003
Huizhou, China, 516001
Actively Recruiting
45
Investigational Site Number : 1560017
Huizhou, China, 516001
Actively Recruiting
46
Investigational Site Number : 1560004
Jiazhuang, China, 050000
Actively Recruiting
47
Investigational Site Number : 1560014
Linhai, China, 317000
Actively Recruiting
48
Investigational Site Number : 1560008
Luoyang, China, 471003
Actively Recruiting
49
Investigational Site Number : 1560005
Shanghai, China, 200120
Actively Recruiting
50
Investigational Site Number : 1560007
Shanghai, China, 200127
Actively Recruiting
51
Investigational Site Number : 1560011
Wuhan, China, 430014
Actively Recruiting
52
Investigational Site Number : 2030001
Olomouc, Czechia, 779 00
Actively Recruiting
53
Investigational Site Number : 2030002
Ostrava, Czechia, 710 00
Actively Recruiting
54
Investigational Site Number : 2500003
Nice, France, 06202
Actively Recruiting
55
Investigational Site Number : 2500001
Toulouse, France, 31059
Actively Recruiting
56
Investigational Site Number : 2500002
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
57
Investigational Site Number : 2680002
Tbilisi, Georgia, 0144
Actively Recruiting
58
Investigational Site Number : 2680003
Tbilisi, Georgia, 0160
Actively Recruiting
59
Investigational Site Number : 2680001
Tbilisi, Georgia, 0180
Actively Recruiting
60
Investigational Site Number : 2760005
Berlin, Germany, 10117
Actively Recruiting
61
Investigational Site Number : 2760008
Berlin, Germany, 14050
Actively Recruiting
62
Investigational Site Number : 2760010
Duisburg, Germany, 47055
Actively Recruiting
63
Investigational Site Number : 2760009
Frankfurt, Germany, 60590
Actively Recruiting
64
Investigational Site Number : 2760003
Hanover, Germany, 30625
Actively Recruiting
65
Investigational Site Number : 2760011
Tübingen, Germany, 72076
Actively Recruiting
66
Investigational Site Number : 2760006
Ulm, Germany, 89081
Actively Recruiting
67
Investigational Site Number : 3000001
Athens, Greece, 106 76
Actively Recruiting
68
Investigational Site Number : 3000003
Athens, Greece, 124 62
Actively Recruiting
69
Investigational Site Number : 3000002
Heraklion, Greece, 711 10
Actively Recruiting
70
Investigational Site Number : 3480001
Budapest, Hungary, 1085
Actively Recruiting
71
Investigational Site Number : 3560005
Hyderabad, India, 500082
Actively Recruiting
72
Investigational Site Number : 3560003
Jaipur, India, 302001
Actively Recruiting
73
Investigational Site Number : 3560009
Jaipur, India, 302004
Actively Recruiting
74
Investigational Site Number : 3560002
Kolkata, India, 700020
Actively Recruiting
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
Actively Recruiting
81
Investigational Site Number : 3800003
Rozzano, Milano, Italy, 20089
Actively Recruiting
82
Investigational Site Number : 3800008
Naples, Napoli, Italy, 80131
Actively Recruiting
83
Investigational Site Number : 3800001
Padua, Padova, Italy, 35128
Actively Recruiting
84
Investigational Site Number : 3800011
Rome, Roma, Italy, 00161
Actively Recruiting
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
Actively Recruiting
88
Investigational Site Number : 3800004
Pisa, Italy, 56124
Actively Recruiting
89
Investigational Site Number : 3920005
Kashiwa, Chiba, Japan, 277-0871
Actively Recruiting
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
Actively Recruiting
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
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
4
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