A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis (ROSETTA)
- Registration Number
- NCT06127043
- Lead Sponsor
- AnaptysBio, Inc.
- Brief Summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
- Detailed Description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of rosnilimab in subjects with moderate to severe ulcerative colitis (UC).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Male or female ≥18
- 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.)
- Subject has a diagnosis of Crohn's disease or indeterminate colitis.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rosnilimab SC Dose 2 Rosnilimab This arm will receive low dose Rosnilimab SC Placebo Placebo This arm will receive Placebo SC Rosnilimab SC Dose 1 Rosnilimab This arm will receive High dose Rosnilimab SC
- Primary Outcome Measures
Name Time Method Mean change in modified Mayo Score (mMs) from Baseline to Week 12 Baseline to Week 12 The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore.
- Secondary Outcome Measures
Name Time Method Proportion of subjects showing endoscopic treatment improvement at Week 12 Baseline to Week 12 Defined as an endoscopy subscore ≤ 1 without friability.
Proportion of subjects achieving clinical remission at Week 12 Baseline to Week 12 Defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS=0, and endoscopic subscore ≤ 1 without friability.
Proportion of subjects achieving a clinical response at Week 12 Baseline to Week 12 Defined as a decrease from Baseline in mMS ≥ 2 points and ≥ 30% with a decrease from Baseline in RBS ≥ 1 point or an absolute RBS ≤ 1.
Trial Locations
- Locations (99)
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 10-109
🇺🇸Miami Gardens, Florida, United States
AnaptysBio Investigational Site 10-106
🇺🇸Miami, 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
🇦🇹St. Polten, 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
🇨🇦Montréal, 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 59-106
🇬🇪Tbilisi, Georgia
AnaptysBio Investigational Site 59-103
🇬🇪Tbilisi, Georgia
AnaptysBio Investigational Site 59-102
🇬🇪Tbilisi, Georgia
AnaptysBio Investigational Site 59-101
🇬🇪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
🇵🇱Kraków, Poland
AnaptysBio Investigational Site 30-123
🇵🇱Kraków, Poland
AnaptysBio Investigational Site 30-114
🇵🇱Lublin, Poland
AnaptysBio Investigational Site 30-104
🇵🇱Poznań, Poland
AnaptysBio Investigational Site 30-117
🇵🇱Poznań, Poland
AnaptysBio Investigational Site 30-120
🇵🇱Poznań, Poland
AnaptysBio Investigational Site 30-116
🇵🇱Rzeszów, Poland
AnaptysBio Investigational Site 30-113
🇵🇱Sopot, Poland
AnaptysBio Investigational Site 30-110
🇵🇱Toruń, Poland
AnaptysBio Investigational Site 30-101
🇷🇴Bucharest, Romania
AnaptysBio Investigational Site 30-107
🇵🇱Warsaw, Poland
AnaptysBio Investigational Site 30-109
🇵🇱Warsaw, Poland
AnaptysBio Investigational Site 30-103
🇵🇱Łódź, Poland
AnaptysBio Investigational Site 30-119
🇵🇱Łódź, Poland
AnaptysBio Investigational Site 31-103
🇷🇴Cluj-Napoca, Romania
AnaptysBio Investigational Site 31-102
🇷🇴Timişoara, Romania
AnaptysBio Investigational Site 58-103
🇷🇸Belgrade, Serbia
AnaptysBio Investigational Site 58-105
🇷🇸Belgrade, Serbia
AnaptysBio Investigational Site 58-101
🇷🇸Belgrad, Serbia
AnaptysBio Investigational Site 58-104
🇷🇸Belgrad, 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