A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
NCT ID: NCT06127043
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
132 participants
INTERVENTIONAL
2023-12-04
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosnilimab SC Dose 1
This arm will receive High dose Rosnilimab SC
Rosnilimab
PD-1 agonist antibody
Rosnilimab SC Dose 2
This arm will receive low dose Rosnilimab SC
Rosnilimab
PD-1 agonist antibody
Placebo
This arm will receive Placebo SC
Placebo
Administered via SC
Interventions
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Rosnilimab
PD-1 agonist antibody
Placebo
Administered via SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with a clinical diagnosis of UC for prior to Day 1
* Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2
* Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon cancer performed within 1 year of Day 1.
* Subject has a history of an inadequate response, loss of response, or intolerance to any combination of at least 2 UC therapy classes defined as, but not limited to, aminosalicylates, corticosteroids, immunomodulators, calcineurin inhibitors, or advanced UC therapies (e.g., biologics, JAK inhibitors, oral S1P receptor modulators, etc.)
Exclusion Criteria
* Subject has a diagnosis of fulminant colitis and/or toxic megacolon.
* Subject has a history of an inadequate response, loss of response, or intolerance to any combination of 3 or more advanced UC therapy classes but not limited to, 1) anti-TNF antibodies (e.g., adalimumab, golimumab, infliximab), 2) other biologics (e.g., ustekinumab, vedolizumab), 3) oral JAK inhibitors (e.g., tofacitinib, upadacitinib), and 4) oral S1P receptor modulators (e.g., ozanimod).
* Subject has disease limited to the rectum (ulcerative proctitis)
* Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.
* The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.
18 Years
ALL
No
Sponsors
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AnaptysBio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Zurab Machaidze, MD
Role: STUDY_DIRECTOR
AnaptysBio, Inc.
Locations
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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
Countries
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Other Identifiers
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ANB030-204 ROSETTA
Identifier Type: -
Identifier Source: org_study_id
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