Crohn's Disease Clinical Trials

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A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (107) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include: The study duration may be up to 286 weeks including: * 40-week Pivotal Maintenance Sub-Study * 240-week Open-Label Extension (OLE) Sub-Study * 45-day Follow-Up visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit. The treatment duration may be up to 280 weeks including: * 40 weeks in the Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:

• Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development)

• Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1

• OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study

Locations
United States
Colorado
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039
RECRUITING
Colorado Springs
Florida
Clinical Research of Osceola-Site Number: 8400013
RECRUITING
Kissimmee
Bioresearch Partner-Kendale Lakes-Site Number: 8400053
RECRUITING
Miami
Columbus Clinical Services LLc-Site Number: 8400038
RECRUITING
Miami
Orlando Health, Inc., Digestive Health Institute-Site Number: 8400084
RECRUITING
Orlando
NMC Research LLC-Site Number: 8400033
RECRUITING
Tampa
Illinois
Illinois Gastroenterology Group d/b/a GI Alliance - Gurnee-Site Number: 8400049
RECRUITING
Gurnee
Indiana
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100
RECRUITING
New Albany
Louisiana
GI Alliance - Baton Rouge-Site Number: 8400129
RECRUITING
Baton Rouge
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128
RECRUITING
Mandeville
GI Alliance - Metairie-Site Number: 8400124
RECRUITING
Metairie
Delta Research Partners-Site Number: 8400087
RECRUITING
Monroe
Missouri
BVL Clinical Research-Site Number: 8400005
RECRUITING
Liberty
Gateway Gastroenterology-Site Number: 8400097
RECRUITING
St Louis
North Carolina
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074
RECRUITING
Chapel Hill
Cross Creek Medical Clinic-Site Number: 8400057
RECRUITING
Fayetteville
New York
MedTraits NY-Site Number: 8400045
RECRUITING
Maspeth
New York Gastroenterology Associates-Site Number: 8400009
RECRUITING
New York
NYU Langone Health-Site Number: 8400091
RECRUITING
New York
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040
RECRUITING
New York
Ohio
Medical Associates Research Group-Site Number: 8400063
RECRUITING
Columbus
Ohio Gastroenterology Group Inc.-Site Number: 8400006
RECRUITING
Columbus
OSU Wexner Medical Center-Site Number: 8400077
RECRUITING
Columbus
North Shore Gastroenterology Research-Site Number: 8400130
RECRUITING
Westlake
Pennsylvania
University of Pennsylvania School of Medicine-Site Number: 8400072
RECRUITING
Philadelphia
The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107
RECRUITING
Pittsburgh
Rhode Island
University Gastroenterology - GI Alliance-Site Number: 8400103
RECRUITING
Providence
Texas
GI Alliance - Lubbock-Site Number: 8400092
RECRUITING
Lubbock
SMS Clinical Research-Site Number: 8400035
RECRUITING
Mesquite
Gastroenterology Research of San Antonio LLC-Site Number: 8400054
RECRUITING
San Antonio
Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake-Site Number: 8400101
RECRUITING
Southlake
Tyler Research Institute LLC-Site Number: 8400095
RECRUITING
Tyler
Washington
The Vancouver Clinic Inc. P.S.-Site Number: 8400090
RECRUITING
Vancouver
Wyoming
Gastroenterology Associates of Western Michigan-Site Number: 8400060
RECRUITING
Wyoming
Other Locations
Australia
Investigational Site Number : 0400002
RECRUITING
Salzburg
Investigational Site Number : 0360001
RECRUITING
South Brisbane
Investigational Site Number : 0400007
RECRUITING
Vienna
Austria
Investigational Site Number : 0400001
RECRUITING
Vienna
Belgium
Investigational Site Number : 0560003
RECRUITING
Yvoir
Brazil
Sao Jose do Rio Preto Regional Faculty of Medicine Foundation-Site Number: 0760006
RECRUITING
São José Do Rio Preto
Bulgaria
Investigational Site Number : 1000003
RECRUITING
Gorna Oryahovitsa
Investigational Site Number : 1000007
RECRUITING
Rousse
Investigational Site Number : 1000001
RECRUITING
Sofia
Canada
Investigational Site Number : 1240004
RECRUITING
Edmonton
Investigational Site Number : 1240009
RECRUITING
Hamilton
Investigational Site Number : 1240013
RECRUITING
London
Investigational Site Number : 1240006
RECRUITING
New Westminster
Investigational Site Number : 1240003
RECRUITING
Toronto
Chile
Investigational Site Number : 1520001
RECRUITING
Viña Del Mar
China
Investigational Site Number : 1560002
RECRUITING
Guangzhou
Investigational Site Number : 1560026
RECRUITING
Huizhou
Investigational Site Number : 1560020
RECRUITING
Shanghai
Investigational Site Number : 1560018
RECRUITING
Wuxi
Georgia
Investigational Site Number : 2680002
RECRUITING
Tbilisi
Investigational Site Number : 2680003
RECRUITING
Tbilisi
Investigational Site Number : 2680004
RECRUITING
Tbilisi
Investigational Site Number : 2680005
RECRUITING
Tbilisi
Investigational Site Number : 2680006
RECRUITING
Tbilisi
Investigational Site Number : 2680008
RECRUITING
Tbilisi
Germany
Investigational Site Number : 2760001
RECRUITING
Kiel
Investigational Site Number : 2760015
RECRUITING
Leipzig
Investigational Site Number : 2760005
RECRUITING
Ulm
Israel
Investigational Site Number : 3760001
RECRUITING
Jerusalem
Investigational Site Number : 3760002
RECRUITING
Tel Aviv
Italy
Investigational Site Number : 3800003
RECRUITING
Rozzano
Investigational Site Number : 3800005
RECRUITING
Turin
Japan
Investigational Site Number : 3920030
RECRUITING
Kamakura
Investigational Site Number : 3920013
RECRUITING
Nishinomiya
Investigational Site Number : 3920009
RECRUITING
Tsu
Lithuania
Investigational Site Number : 4400001
RECRUITING
Kaunas
Netherlands
Investigational Site Number : 5280003
RECRUITING
Tilburg
New Zealand
Investigational Site Number : 5540003
RECRUITING
Lower Hutt
Poland
Investigational Site Number : 6160026
RECRUITING
Bydgoszcz
Investigational Site Number : 6160013
RECRUITING
Elblag
Investigational Site Number : 6160014
RECRUITING
Katowice
Investigational Site Number : 6160030
RECRUITING
Kłodzko
Investigational Site Number : 6160034
RECRUITING
Lublin
Investigational Site Number : 6160025
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Rzeszów
Investigational Site Number : 6160007
RECRUITING
Staszów
Investigational Site Number : 6160020
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Szczecin
Investigational Site Number : 6160023
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Torun
Investigational Site Number : 6160012
RECRUITING
Wadowice
Investigational Site Number : 6160008
RECRUITING
Warsaw
Investigational Site Number : 6160006
RECRUITING
Wroclaw
Investigational Site Number : 6160017
RECRUITING
Wroclaw
Republic of Korea
Investigational Site Number : 4100008
RECRUITING
Busan
Investigational Site Number : 4100007
RECRUITING
Gwangju
Investigational Site Number : 4100002
RECRUITING
Seoul
Investigational Site Number : 4100006
RECRUITING
Seoul
Republic of Moldova
Investigational Site Number : 4980002
RECRUITING
Chisinau
Investigational Site Number : 4980003
RECRUITING
Chisinau
Investigational Site Number : 4980004
RECRUITING
Chisinau
Serbia
Investigational Site Number : 6880002
RECRUITING
Belgrade
Slovakia
Investigational Site Number : 7030001
RECRUITING
Bratislava
South Africa
Investigational Site Number : 7100002
RECRUITING
Cape Town
Investigational Site Number : 7100004
RECRUITING
Durban
Investigational Site Number : 7100001
RECRUITING
Kempton Park
Switzerland
Investigational Site Number : 7560002
RECRUITING
Basel
Investigational Site Number : 7560001
RECRUITING
Bern
Taiwan
Investigational Site Number : 1580005
RECRUITING
Changhua County
Ukraine
Investigational Site Number : 8040001
RECRUITING
Kyiv
Investigational Site Number : 8040013
RECRUITING
Kyiv
Investigational Site Number : 8040004
RECRUITING
Lviv
Investigational Site Number : 8040005
RECRUITING
Lviv
Investigational Site Number : 8040006
RECRUITING
Uzhhorod
Investigational Site Number : 8040009
RECRUITING
Vinnytsia
Investigational Site Number : 8040010
RECRUITING
Vinnytsia
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2034-03-20
Participants
Target number of participants: 751
Treatments
Experimental: Duvakitug dose 1
Subcutaneous (SC) injection as per protocol
Experimental: Du vakitug dose 2
SC injection as per protocol
Experimental: Du vakitug dose 3
SC injection as per protocol
Placebo_comparator: Placebo
SC injection as per protocol
Related Therapeutic Areas
Sponsors
Collaborators: Teva Branded Pharmaceutical Products R&D LLC
Leads: Sanofi

This content was sourced from clinicaltrials.gov