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A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
Sponsor: AnaptysBio, Inc.
Summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2023-12-04
Completion Date
2026-05
Last Updated
2025-10-03
Healthy Volunteers
No
Conditions
Interventions
Rosnilimab
PD-1 agonist antibody
Placebo
Administered via SC
Locations (100)
AnaptysBio Investigational Site 10-115
Phoenix, Arizona, United States
AnaptysBio Investigational Site 10-117
Garden Grove, California, United States
AnaptysBio Investigational Site 10-112
Lancaster, California, United States
AnaptysBio Investigational Site 10-129
Lancaster, California, United States
AnaptysBio Investigational Site 10-108
San Jose, California, United States
AnaptysBio Investigational Site 10-127
Brooksville, Florida, United States
AnaptysBio Investigational Site 10-106
Miami, Florida, United States
AnaptysBio Investigational Site 10-109
Miami Gardens, Florida, United States
AnaptysBio Investigational Site 10-131
Orlando, Florida, United States
AnaptysBio Investigational Site 10-123
Orlando, Florida, United States
AnaptysBio Investigational Site 10-125
Tampa, Florida, United States
AnaptysBio Investigational Site 10-122
Atlanta, Georgia, United States
AnaptysBio Investigational Site 10-124
Oak Lawn, Illinois, United States
AnaptysBio Investigational Site 10-118
Las Vegas, Nevada, United States
AnaptysBio Investigational Site 10-133
Utica, New York, United States
AnaptysBio Investigational Site 10-136
Cincinnati, Ohio, United States
AnaptysBio Investigational Site 10-120
Norman, Oklahoma, United States
AnaptysBio Investigational Site 10-103
Kingsport, Tennessee, United States
AnaptysBio Investigational Site 10-104
Dallas, Texas, United States
AnaptysBio Investigational Site 10-113
Garland, Texas, United States
AnaptysBio Investigational Site 10-135
Georgetown, Texas, United States
AnaptysBio Investigational Site 10-134
Lubbock, Texas, United States
AnaptysBio Investigational Site 10-130
Southlake, Texas, United States
AnaptysBio Investigational Site 10-132
Tyler, Texas, United States
AnaptysBio Investigational Site 10-107
Seattle, Washington, United States
AnaptysBio Investigational Site 12-101
Innsbruck, Austria
AnaptysBio Investigational Site 12-104
Salzburg, Austria
AnaptysBio Investigational Site 12-103
Sankt Pölten, Austria
AnaptysBio Investigational Site 12-102
Vienna, Austria
AnaptysBio Investigational Site 61-102
Sofia, Bulgaria
AnaptysBio Investigational Site 11-102
London, Ontario, Canada
AnaptysBio Investigational Site 11-103
Montreal, Quebec, Canada
AnaptysBio Investigational Site 11-105
Calgary, Canada
AnaptysBio Investigational Site 74-104
Rijeka, Croatia
AnaptysBio Investigational Site 74-101
Zagreb, Croatia
AnaptysBio Investigational Site 16-102
Nantes, France
AnaptysBio Investigational Site 16-103
Nantes, France
AnaptysBio Investigational Site 16-101
Tours, France
AnaptysBio Investigational Site 59-101
Tbilisi, Georgia, Georgia
AnaptysBio Investigational Site 59-106
Tbilisi, Georgia
AnaptysBio Investigational Site 59-103
Tbilisi, Georgia
AnaptysBio Investigational Site 59-102
Tbilisi, Georgia
AnaptysBio Investigational Site 59-104
Tbilisi, Georgia
AnaptysBio Investigational Site 59-105
Tbilisi, Georgia
AnaptysBio Investigational Site 17-107
Berlin, Germany
AnaptysBio Investigational Site 17-106
Brandenburg, Germany
AnaptysBio Investigational Site 17-105
Dachau, Germany
AnaptysBio Investigational Site 17-101
Duisburg, Germany
AnaptysBio Investigational Site 17-110
Erlangen, Germany
AnaptysBio Investigational Site 17-108
Hamburg, Germany
AnaptysBio Investigational Site 17-103
Kiel, Germany
AnaptysBio Investigational Site 17-109
Ulm, Germany
AnaptysBio Investigational Site 20-112
Bologna, Italy
AnaptysBio Investigational Site 20-111
Cagliari, Italy
AnaptysBio Investigational Site 20-110
Catania, Italy
AnaptysBio Investigational Site 20-108
Legnano, Italy
AnaptysBio Investigational Site 20-105
Milan, Italy
AnaptysBio Investigational Site 20-107
Pavia, Italy
AnaptysBio Investigational Site 20-102
Rozzano, Italy
AnaptysBio Investigational Site 20-109
San Donato, Italy
AnaptysBio Investigational Site 20-104
San Giovanni, Italy
AnaptysBio Investigational Site 20-113
Turin, Italy
AnaptysBio Investigational Site 20-106
Udine, Italy
AnaptysBio Investigational Site 21-101
Amsterdam, Netherlands
AnaptysBio Investigational Site 30-108
Bydgoszcz, Poland
AnaptysBio Investigational Site 30-106
Częstochowa, Poland
AnaptysBio Investigational Site 30-112
Elblag, Poland
AnaptysBio Investigational Site 30-102
Katowice, Poland
AnaptysBio Investigational Site 30-115
Katowice, Poland
AnaptysBio Investigational Site 30-111
Krakow, Poland
AnaptysBio Investigational Site 30-123
Krakow, Poland
AnaptysBio Investigational Site 30-103
Lodz, Poland
AnaptysBio Investigational Site 30-119
Lodz, Poland
AnaptysBio Investigational Site 30-114
Lublin, Poland
AnaptysBio Investigational Site 30-104
Poznan, Poland
AnaptysBio Investigational Site 30-117
Poznan, Poland
AnaptysBio Investigational Site 30-120
Poznan, Poland
AnaptysBio Investigational Site 30-116
Rzeszów, Poland
AnaptysBio Investigational Site 30-113
Sopot, Poland
AnaptysBio Investigational Site 30-110
Torun, Poland
AnaptysBio Investigational Site 30-101
Warsaw, Poland
AnaptysBio Investigational Site 30-107
Warsaw, Poland
AnaptysBio Investigational Site 30-109
Warsaw, Poland
AnaptysBio Investigational Site 30-101
Bucharest, Romania
AnaptysBio Investigational Site 31-103
Cluj-Napoca, Romania
AnaptysBio Investigational Site 31-102
Timișoara, Romania
AnaptysBio Investigational Site 58-101
Belgrade, Serbia
AnaptysBio Investigational Site 58-103
Belgrade, Serbia
AnaptysBio Investigational Site 58-104
Belgrade, Serbia
AnaptysBio Investigational Site 58-105
Belgrade, Serbia
AnaptysBio Investigational Site 58-102
Zrenjanin, Serbia
AnaptysBio Investigational Site 24-102
Alicante, Spain
AnaptysBio Investigational Site 24-103
Lleida, Spain
AnaptysBio Investigational Site 27-103
Belfast, United Kingdom
AnaptysBio Investigational Site 27-102
Cambridge, United Kingdom
AnaptysBio Investigational Site 27-106
Liverpool, United Kingdom
AnaptysBio Investigational Site 27-101
London, United Kingdom
AnaptysBio Investigational Site 27-105
Runcorn, United Kingdom
AnaptysBio Investigational Site 27-107
Shrewsbury, United Kingdom
AnaptysBio Investigational Site 27-104
York, United Kingdom