Actively Recruiting
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
Led by Sanofi · Updated on 2026-04-21
260
Participants Needed
138
Research Sites
232 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 Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.
CONDITIONS
Official Title
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years at the time of signing the informed consent form
- Confirmed diagnosis of Crohn's Disease for at least 3 months before baseline
- Confirmed moderate to severe Crohn's Disease based on Crohn's Disease Activity Index score, Simple Endoscopic Score, stool frequency, and abdominal pain score
- History of prior exposure to standard treatments or advanced therapies with inadequate response, loss of response, or intolerance to at least one
- On stable doses of standard treatments such as oral 5-ASA compounds, corticosteroids, thiopurines, or methotrexate before screening
- Use of contraception by men and women according to local regulations; women must not be pregnant or breastfeeding
You will not qualify if you...
- Active ulcerative colitis, indeterminate colitis, or short bowel syndrome
- Crohn's Disease limited to stomach, duodenum, jejunum, or perianal region without colon or ileum involvement
- Known ongoing complications of Crohn's Disease such as fistula, abscess, symptomatic stricture, fulminant colitis, toxic megacolon, recent bowel resection within 3 months, or more than 3 bowel resections in history
- Stool sample positive for infectious pathogens
- Active tuberculosis or incompletely treated tuberculosis
- Positive Hepatitis B surface antigen or core antibody, or positive Hepatitis C antibody at screening
- Any active, chronic, or recurrent infections including herpes zoster or herpes simplex
- Known HIV infection or positive HIV serology at screening
- Active malignancies or lymphoproliferative diseases within 5 years before screening
- History or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening
- Infection requiring intravenous anti-infective treatment within 30 days or oral/intramuscular anti-infectives within 14 days before screening
- Need for or receiving parenteral or exclusive enteral nutrition
- Use of cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days before screening
- Fecal microbial transplantation within 30 days before screening
- Previous exposure to natalizumab or oral carotegrast methyl
- Intravenous corticosteroids within 14 days before or during screening
- Therapeutic enema or suppository use within 14 days before or during screening, except for colonoscopy
- Abnormal lab or other screening test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 locations
1
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
Sun City, Arizona, United States, 85351
Actively Recruiting
2
Bristol Hospital- Site Number : 8400007
Bristol, Connecticut, United States, 06010
Actively Recruiting
3
Novum Research- Site Number : 8400021
Clermont, Florida, United States, 34711
Actively Recruiting
4
Homestead Associates in Research- Site Number : 8400012
Homestead, Florida, United States, 33033
Actively Recruiting
5
Clinical Research of Osceola- Site Number : 8400013
Kissimmee, Florida, United States, 34741
Actively Recruiting
6
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
Miami Lakes, Florida, United States, 33016
Actively Recruiting
7
GCP Clinical Research- Site Number : 8400004
Tampa, Florida, United States, 33609
Actively Recruiting
8
GI Alliance - Glenview- Site Number : 8400015
Glenview, Illinois, United States, 60026
Actively Recruiting
9
Illinois Gastroenterology Group- Site Number : 8400011
Gurnee, Illinois, United States, 60031
Actively Recruiting
10
University of Michigan Health System - Ann Arbor- Site Number : 8400017
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
GI Alliance - Flowood- Site Number : 8400019
Flowood, Mississippi, United States, 39232
Actively Recruiting
12
Vector Clinical Trials- Site Number : 8400001
Las Vegas, Nevada, United States, 89128
Actively Recruiting
13
Queens Village Primary Medical Center- Site Number : 8400005
Queens Village, New York, United States, 11428
Actively Recruiting
14
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
Greenville, North Carolina, United States, 27834
Actively Recruiting
15
Frontier Clinical Research - Uniontown- Site Number : 8400009
Uniontown, Pennsylvania, United States, 15401
Actively Recruiting
16
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016
Charleston, South Carolina, United States, 29401
Actively Recruiting
17
Gastro Health & Nutrition- Site Number : 8400003
Katy, Texas, United States, 77494
Actively Recruiting
18
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
Southlake, Texas, United States, 76092
Actively Recruiting
19
Washington Gastroenterology - Tacoma- Site Number : 8400008
Tacoma, Washington, United States, 98405
Actively Recruiting
20
Investigational Site Number : 0320002
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
21
Investigational Site Number : 0320003
Buenos Aires, Argentina, 1061
Actively Recruiting
22
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1119
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23
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1125
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24
Investigational Site Number : 0320004
Buenos Aires, Argentina, 1221
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25
Investigational Site Number : 0320006
Buenos Aires, Argentina, 1280
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26
Investigational Site Number : 0360002
Sydney, New South Wales, Australia, 2139
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27
Investigational Site Number : 0360001
South Brisbane, Queensland, Australia, 4101
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28
Investigational Site Number : 0360003
Parkville, Victoria, Australia, 3050
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29
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
Salvador, Estado de Bahia, Brazil, 41820-020
Actively Recruiting
30
Hospital Moinhos de Vento- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, Brazil, 90035-902
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31
Hospital de Clinicas de Porto Alegre- Site Number : 0760007
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Actively Recruiting
32
Hospital Ernesto Dornelles- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
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33
Pesquisare Saude- Site Number : 0760004
Santo André, São Paulo, Brazil, 09080-110
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34
Investigational Site Number : 1000001
Gorna Oryahovitsa, Bulgaria, 5100
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35
Investigational Site Number : 1000004
Sofia, Bulgaria, 1431
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36
Investigational Site Number : 1000005
Sofia, Bulgaria, 1680
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37
Investigational Site Number : 1240001
Calgary, Alberta, Canada, T2N 4Z6
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38
Investigational Site Number : 1240003
Montreal, Quebec, Canada, H3H 1E8
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39
Investigational Site Number : 1240005
Québec, Quebec, Canada, G1N 4V3
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40
Investigational Site Number : 1520006
Concepción, Biobio, Chile, 4070038
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41
Investigational Site Number : 1520004
Talcahuano, Biobio, Chile, 2687000
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42
Investigational Site Number : 1520007
Temuco, La Araucanía, Chile, 4781156
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43
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 8331143
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44
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 8380456
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45
Investigational Site Number : 1520002
Viña del Mar, Valparaiso, Chile, 2540364
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46
Investigational Site Number : 1560008
Changzhou, China, 213003
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47
Investigational Site Number : 1560009
Chongqing, China, 400013
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48
Investigational Site Number : 1560012
Fuzhou, China, 350005
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49
Investigational Site Number : 1560001
Guangzhou, China, 510080
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50
Investigational Site Number : 1560002
Guangzhou, China, 510655
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51
Investigational Site Number : 1560004
Hangzhou, China, 310009
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52
Investigational Site Number : 1560003
Hangzhou, China, 310016
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53
Investigational Site Number : 1560007
Hefei, China, 230022
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54
Investigational Site Number : 1560011
Nanchang, China, 330006
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55
Investigational Site Number : 1560006
Shanghai, China, 200025
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56
Investigational Site Number : 1560005
Shanghai, China, 200127
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57
Investigational Site Number : 1560010
Suzhou, China, 215004
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58
Investigational Site Number : 1910004
Osijek, Croatia, 31000
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59
Investigational Site Number : 1910003
Zagreb, Croatia, 10000
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60
Investigational Site Number : 2030003
Brno, Czechia, 602 00
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61
Investigational Site Number : 2030002
Brno, Czechia, 636 00
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62
Investigational Site Number : 2030004
Hradec Králové, Czechia, 500 12
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63
Investigational Site Number : 2500005
Montpellier, France, 34295
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64
Investigational Site Number : 2500002
Nice, France, 06202
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65
Investigational Site Number : 2500004
Saint-Priest-en-Jarez, France, 42270
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66
Investigational Site Number : 2500003
Toulouse, France, 31059
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67
Investigational Site Number : 2500001
Vandœuvre-lès-Nancy, France, 54511
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68
Investigational Site Number : 2680006
Kutaisi, Georgia, 4600
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69
Investigational Site Number : 2680007
Tbilisi, Georgia, 0102
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70
Investigational Site Number : 2680001
Tbilisi, Georgia, 0144
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71
Investigational Site Number : 2680005
Tbilisi, Georgia, 0159
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72
Investigational Site Number : 2680002
Tbilisi, Georgia, 0160
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73
Investigational Site Number : 2680003
Tbilisi, Georgia, 0172
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74
Investigational Site Number : 2680004
Tbilisi, Georgia, 0180
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75
Investigational Site Number : 2760004
Berlin, Germany, 10318
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76
Investigational Site Number : 2760002
Berlin, Germany, 12203
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77
Investigational Site Number : 2760001
Fulda, Germany, 36043
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78
Investigational Site Number : 2760005
Halle, Germany, 06108
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79
Investigational Site Number : 2760006
Ludwigshafen, Germany, 67067
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80
Investigational Site Number : 3480003
Békéscsaba, Hungary, 5600
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81
Investigational Site Number : 3480008
Budapest, Hungary, 1085
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82
Investigational Site Number : 3480001
Gyöngyös, Hungary, 3200
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83
Investigational Site Number : 3480009
Gyöngyös, Hungary, 3200
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84
Investigational Site Number : 3480005
Szeged, Hungary, 6720
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85
Investigational Site Number : 3480006
Szekszárd, Hungary, 7100
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86
Investigational Site Number : 3480004
Tatabánya, Hungary, 2800
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87
Investigational Site Number : 3560007
Hyderabad, India, 500032
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88
Investigational Site Number : 3560003
Hyderabad, India, 500048
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89
Investigational Site Number : 3560009
Jaipur, India, 302001
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90
Investigational Site Number : 3560001
Jaipur, India, 302007
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91
Investigational Site Number : 3560005
Kolkata, India, 700020
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92
Investigational Site Number : 3560006
Pune, India, 412201
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93
Investigational Site Number : 3560002
Secunderabad, India, 500003
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94
Investigational Site Number : 3560013
Surat, India, 395002
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95
Investigational Site Number : 3560010
Surat, India, 395010
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96
Investigational Site Number : 3800009
Milan, Milano, Italy, 20097
Actively Recruiting
97
Investigational Site Number : 3800002
Milan, Milano, Italy, 20132
Actively Recruiting
98
Investigational Site Number : 3800004
Rozzano, Milano, Italy, 20089
Actively Recruiting
99
Investigational Site Number : 3800001
Padua, Padova, Italy, 35128
Actively Recruiting
100
Investigational Site Number : 3800008
Rome, Roma, Italy, 00128
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101
Investigational Site Number : 3800006
Rome, Roma, Italy, 00168
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102
Investigational Site Number : 3800005
Pisa, Italy, 56124
Actively Recruiting
103
Investigational Site Number : 3920004
Kashiwa, Chiba, Japan, 277-0871
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104
Investigational Site Number : 3920001
Sakura, Chiba, Japan, 285-0841
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105
Investigational Site Number : 3920005
Kitakyushu, Fukuoka, Japan, 802-0077
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106
Investigational Site Number : 3920006
Sapporo, Hokkaido, Japan, 004-0041
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107
Investigational Site Number : 3920010
Sapporo, Hokkaido, Japan, 064-0919
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108
Investigational Site Number : 3920007
Sapporo, Hokkaido, Japan, 065-0033
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109
Investigational Site Number : 3920008
Yahaba, Iwate, Japan, 028-3695
Actively Recruiting
110
Investigational Site Number : 3920019
Takamatsu, Kagawa-ken, Japan, 760-0017
Actively Recruiting
111
Investigational Site Number : 3920020
Nagaoka, Niigata, Japan, 940-2108
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112
Investigational Site Number : 3920003
Bunkyo, Tokyo, Japan, 113-8510
Actively Recruiting
113
Investigational Site Number : 3920013
Hiroshima, Japan, 734-0004
Actively Recruiting
114
Investigational Site Number : 3920018
Ōita, Japan, 870-0033
Actively Recruiting
115
Investigational Site Number : 3920011
Tokyo, Japan, 169-0073
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116
Investigational Site Number : 3920012
Wakayama, Japan, 640-8558
Actively Recruiting
117
Investigational Site Number : 4800001
Vacoas, Mauritius, 72218
Actively Recruiting
118
Investigational Site Number : 5280004
Breda, Netherlands, 4818 CK
Actively Recruiting
119
Investigational Site Number : 5280002
Nijmegen, Netherlands, 6525 GA
Actively Recruiting
120
Investigational Site Number : 5280001
Tilburg, Netherlands, 5022 GC
Actively Recruiting
121
Investigational Site Number : 5280003
Utrecht, Netherlands, 3584 CX
Actively Recruiting
122
Investigational Site Number : 6160005
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Actively Recruiting
123
Investigational Site Number : 6160006
Lublin, Lublin Voivodeship, Poland, 20-582
Actively Recruiting
124
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, Poland, 00-332
Actively Recruiting
125
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland, 02-507
Actively Recruiting
126
Investigational Site Number : 6160002
Sopot, Pomeranian Voivodeship, Poland, 81-756
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127
Investigational Site Number : 6420004
Bucharest, Romania, 011461
Actively Recruiting
128
Investigational Site Number : 6420003
Constanța, Romania, 900673
Actively Recruiting
129
Investigational Site Number : 6420001
Timișoara, Romania, 300002
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130
Investigational Site Number : 4100002
Haeundae-Gu, Busan, South Korea, 48108
Actively Recruiting
131
Investigational Site Number : 4100001
Daegu, Daegu, South Korea, 41944
Actively Recruiting
132
Investigational Site Number : 4100003
Daejeon, Daejeon, South Korea, 34943
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133
Investigational Site Number : 7240002
Seville, Sevilla, Spain, 41009
Actively Recruiting
134
Investigational Site Number : 7240001
Madrid, Spain, 28046
Actively Recruiting
135
Investigational Site Number : 7920003
Istanbul, Turkey (Türkiye), 34899
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136
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye), 33070
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137
Investigational Site Number : 7920006
Sanliurfa, Turkey (Türkiye), 63290
Actively Recruiting
138
Investigational Site Number : 7920002
Zonguldak, Turkey (Türkiye), 67000
Actively Recruiting
Research Team
T
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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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