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 Ulcerative Colitis
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). 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 Pivotal Maintenance Sub-Study * 240 weeks in OLE Sub-Study The total number of on-site visit will be up to 32: * 21 visits in the Pivotal Maintenance Sub-Study. * 11 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 SUNSCAPE-1
• OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Locations
United States
Arizona
Del Sol Research Management, LLC - Site Number: 8400012
RECRUITING
Tucson
California
Southern California GI & Liver Centers - Site Number: 8400062
RECRUITING
Coronado
United Medical Doctors CA - Site Number: 8400044
RECRUITING
Murrieta
Om Research, LLC - Victorville - Site Number: 8400022
RECRUITING
Victorville
Colorado
Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039
RECRUITING
Colorado Springs
Florida
Royal Palm Clinical Research - Site Number: 8400065
RECRUITING
Fort Myers
Clinical Research of Osceola - Site Number: 8400013
RECRUITING
Kissimmee
Bioresearch Partner-Kendale Lakes - Site Number: 8400053
RECRUITING
Miami
NMC Research LLC - Site Number: 8400033
RECRUITING
Tampa
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
Delta Research Partners - Site Number: 8400087
RECRUITING
Monroe
Michigan
Gastroenterology Associates of Western Michigan - Site Number: 8400060
RECRUITING
Wyoming
Missouri
Gateway Gastroenterology - Site Number: 8400097
RECRUITING
Chesterfield
BVL Clinical Research - Site Number: 8400005
RECRUITING
Liberty
North Carolina
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
Ohio
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
Texas
GI Alliance - Lubbock - Site Number: 8400092
RECRUITING
Lubbock
Gastroenterology Research of San Antonio LLC - Site Number: 8400054
RECRUITING
San Antonio
Tyler Research Institute, LLC - Site Number: 8400095
RECRUITING
Tyler
Washington
The Vancouver Clinic Inc. P.S. - Site Number: 8400090
RECRUITING
Vancouver
Other Locations
Canada
Investigational Site Number : 1240003
RECRUITING
Toronto
Japan
Tokai University Hachioji Hospital - Site Number : 3920031
RECRUITING
Hachiōji
Investigational Site Number : 3920049
RECRUITING
Kagoshima
Investigational Site Number : 3920030
RECRUITING
Kamakura
Investigational Site Number : 3920019
RECRUITING
Kobe
Investigational Site Number : 3920029
RECRUITING
Sapporo
Investigational Site Number : 3920009
RECRUITING
Tsu
Serbia
Investigational Site Number : 6880001
RECRUITING
Belgrade
Investigational Site Number : 6880002
RECRUITING
Belgrade
Ukraine
Investigational Site Number : 8040001
RECRUITING
Kyiv
Investigational Site Number : 8040002
RECRUITING
Kyiv
Investigational Site Number : 8040005
RECRUITING
Lviv
Investigational Site Number : 8040006
RECRUITING
Uzhhorod
Investigational Site Number : 8040008
RECRUITING
Vinnytsia
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)