A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.

Status: Recruiting
Location: See all (120) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

∙ 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 at the time of signing the ICF

• Confirmed diagnosis of CD for at least 3 months prior to Baseline

• Confirmed diagnosis of moderate to severe CD as assessed by:

‣ Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader

⁃ stool frequency (SF), abdominal pain (AP) score

• History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies

• On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX ..)

• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Locations
United States
Arizona
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
RECRUITING
Sun City
Connecticut
Bristol Hospital- Site Number : 8400007
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Bristol
Florida
Novum Research- Site Number : 8400021
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Clermont
Homestead Associates in Research- Site Number : 8400012
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Homestead
Clinical Research of Osceola- Site Number : 8400013
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Kissimmee
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
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Miami Lakes
GCP Clinical Research- Site Number : 8400004
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Tampa
Illinois
GI Alliance - Glenview- Site Number : 8400015
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Glenview
Illinois Gastroenterology Group- Site Number : 8400011
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Gurnee
Michigan
University of Michigan Health System - Ann Arbor- Site Number : 8400017
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Ann Arbor
Mississippi
GI Alliance - Flowood- Site Number : 8400019
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Flowood
North Carolina
Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
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Greenville
Nevada
Vector Clinical Trials- Site Number : 8400001
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Las Vegas
New York
Queens Village Primary Medical Center- Site Number : 8400005
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Queens Village
Pennsylvania
Frontier Clinical Research - Uniontown- Site Number : 8400009
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Uniontown
Texas
Gastro Health & Nutrition- Site Number : 8400003
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Katy
Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
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Southlake
Washington
Washington Gastroenterology - Tacoma- Site Number : 8400008
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Tacoma
Other Locations
Argentina
Investigational Site Number : 0320001
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Buenos Aires
Investigational Site Number : 0320003
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Buenos Aires
Investigational Site Number : 0320004
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Buenos Aires
Investigational Site Number : 0320005
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Buenos Aires
Investigational Site Number : 0320006
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Buenos Aires
Investigational Site Number : 0320002
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San Miguel De Tucumán
Australia
Investigational Site Number : 0360003
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Parkville
Investigational Site Number : 0360001
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South Brisbane
Investigational Site Number : 0360002
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Sydney
Brazil
Hospital Ernesto Dornelles- Site Number : 0760002
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Porto Alegre
Hospital Moinhos de Vento- Site Number : 0760006
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Porto Alegre
Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
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Salvador
Pesquisare Saude- Site Number : 0760004
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Santo André
Bulgaria
Investigational Site Number : 1000001
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Gorna Oryahovitsa
Investigational Site Number : 1000004
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Sofia
Canada
Investigational Site Number : 1240001
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Calgary
Investigational Site Number : 1240003
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Montreal
Investigational Site Number : 1240005
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Québec
Chile
Investigational Site Number : 1520006
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Concepción
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520003
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Santiago
Investigational Site Number : 1520004
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Talcahuano
Investigational Site Number : 1520007
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Temuco
Investigational Site Number : 1520002
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Viña Del Mar
China
Investigational Site Number : 1560008
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Changzhou
Investigational Site Number : 1560009
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Chongqing
Investigational Site Number : 1560012
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Fuzhou
Investigational Site Number : 1560001
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Guangzhou
Investigational Site Number : 1560002
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Guangzhou
Investigational Site Number : 1560003
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Hangzhou
Investigational Site Number : 1560004
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Hangzhou
Investigational Site Number : 1560007
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Hefei
Investigational Site Number : 1560011
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Nanchang
Investigational Site Number : 1560005
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Shanghai
Investigational Site Number : 1560006
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Shanghai
Investigational Site Number : 1560010
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Suzhou
France
Investigational Site Number : 2500002
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Nice
Investigational Site Number : 2500004
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Saint-priest-en-jarez
Investigational Site Number : 2500001
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Vandœuvre-lès-nancy
Georgia
Investigational Site Number : 2680001
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Tbilisi
Investigational Site Number : 2680002
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Tbilisi
Investigational Site Number : 2680003
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Tbilisi
Investigational Site Number : 2680004
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Tbilisi
Investigational Site Number : 2680005
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Tbilisi
Investigational Site Number : 2680007
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Tbilisi
Germany
Investigational Site Number : 2760002
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Berlin
Investigational Site Number : 2760004
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Berlin
Investigational Site Number : 2760001
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Fulda
Investigational Site Number : 2760005
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Halle
Investigational Site Number : 2760006
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Ludwigshafen
Hungary
Investigational Site Number : 3480009
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Gyöngyös
Investigational Site Number : 3480005
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Szeged
Investigational Site Number : 3480006
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Szekszárd
Investigational Site Number : 3480004
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Tatabánya
India
Investigational Site Number : 3560003
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Hyderabad
Investigational Site Number : 3560007
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Hyderabad
Investigational Site Number : 3560001
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Jaipur
Investigational Site Number : 3560009
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Jaipur
Investigational Site Number : 3560002
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Secunderabad
Investigational Site Number : 3560010
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Surat
Investigational Site Number : 3560013
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Surat
Italy
Investigational Site Number : 3800002
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Milan
Investigational Site Number : 3800009
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Milan
Investigational Site Number : 3800001
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Padua
Investigational Site Number : 3800005
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Pisa
Investigational Site Number : 3800006
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Rome
Investigational Site Number : 3800008
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Rome
Investigational Site Number : 3800004
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Rozzano
Japan
Investigational Site Number : 3920003
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Bunkyo
Investigational Site Number : 3920013
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Hiroshima
Investigational Site Number : 3920004
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Kashiwa
Investigational Site Number : 3920005
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Kitakyushu
Investigational Site Number : 3920008
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Morioka
Investigational Site Number : 3920020
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Nagaoka
Investigational Site Number : 3920018
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Ōita
Investigational Site Number : 3920002
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Osaka
Investigational Site Number : 3920001
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Sakura
Investigational Site Number : 3920006
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Sapporo
Investigational Site Number : 3920007
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Sapporo
Investigational Site Number : 3920010
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Sapporo
Investigational Site Number : 3920019
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Takamatsu
Investigational Site Number : 3920011
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Tokyo
Investigational Site Number : 3920012
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Wakayama
Mauritius
Investigational Site Number : 4800001
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Vacoas
Netherlands
Investigational Site Number : 5280004
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Breda
Investigational Site Number : 5280002
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Nijmegen
Investigational Site Number : 5280001
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Tilburg
Investigational Site Number : 5280003
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Utrecht
Poland
Investigational Site Number : 6160006
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Lublin
Investigational Site Number : 6160002
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Sopot
Investigational Site Number : 6160005
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Torun
Investigational Site Number : 6160004
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Warsaw
Republic of Korea
Investigational Site Number : 4100001
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Daegu
Investigational Site Number : 4100003
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Daejeon
Investigational Site Number : 4100002
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Haeundae-gu
Romania
Investigational Site Number : 6420004
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Bucharest
Investigational Site Number : 6420003
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Constanța
Spain
Investigational Site Number : 7240001
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Madrid
Investigational Site Number : 7240002
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Seville
Turkey
Investigational Site Number : 7920003
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Istanbul
Investigational Site Number : 7920001
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Mersin
Investigational Site Number : 7920002
RECRUITING
Zonguldak
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2029-05-23
Participants
Target number of participants: 260
Treatments
Experimental: SAR441566 dose 1
Participants will receive SAR441566 dose 1.
Experimental: SAR441566 dose 2
Participants will receive SAR441566 dose 2.
Experimental: SAR441566 dose 3
Participants will receive SAR441566 dose 3.
Placebo_comparator: Placebo
Participants will receive SAR441566 matching placebo.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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