Clinical trial NCT06127043: A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis (ROSETTA)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Rosnilimab
ANB030
PD-1 agonist
ROSETTA
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean change in modified Mayo Score (mMs) from Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Proportion of subjects achieving clinical remission at Week 12
timeFrame: Baseline to Week 12
measure: Proportion of subjects showing endoscopic treatment improvement at Week 12
timeFrame: Baseline to Week 12
measure: Proportion of subjects achieving a clinical response at Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: AnaptysBio Investigational Site 10-115
state: Arizona
city: Garden Grove
country: United States
facility: AnaptysBio Investigational Site 10-117
state: California
city: Lancaster
country: United States
facility: AnaptysBio Investigational Site 10-112
state: California
city: Lancaster
country: United States
facility: AnaptysBio Investigational Site 10-129
state: California
city: San Jose
country: United States
facility: AnaptysBio Investigational Site 10-108
state: California
city: Brooksville
country: United States
facility: AnaptysBio Investigational Site 10-127
state: Florida
city: Miami Gardens
country: United States
facility: AnaptysBio Investigational Site 10-109
state: Florida
city: Miami
country: United States
facility: AnaptysBio Investigational Site 10-106
state: Florida
city: Orlando
country: United States
facility: AnaptysBio Investigational Site 10-131
state: Florida
city: Orlando
country: United States
facility: AnaptysBio Investigational Site 10-123
state: Florida
city: Tampa
country: United States
facility: AnaptysBio Investigational Site 10-125
state: Florida
city: Atlanta
country: United States
facility: AnaptysBio Investigational Site 10-122
state: Georgia
city: Oak Lawn
country: United States
facility: AnaptysBio Investigational Site 10-124
state: Illinois
city: Las Vegas
country: United States
facility: AnaptysBio Investigational Site 10-118
state: Nevada
city: Utica
country: United States
facility: AnaptysBio Investigational Site 10-133
state: New York
city: Cincinnati
country: United States
facility: AnaptysBio Investigational Site 10-136
state: Ohio
city: Norman
country: United States
facility: AnaptysBio Investigational Site 10-120
state: Oklahoma
city: Kingsport
country: United States
facility: AnaptysBio Investigational Site 10-103
state: Tennessee
city: Dallas
country: United States
facility: AnaptysBio Investigational Site 10-104
state: Texas
city: Garland
country: United States
facility: AnaptysBio Investigational Site 10-113
state: Texas
city: Georgetown
country: United States
facility: AnaptysBio Investigational Site 10-135
state: Texas
city: Lubbock
country: United States
facility: AnaptysBio Investigational Site 10-134
state: Texas
city: Southlake
country: United States
facility: AnaptysBio Investigational Site 10-130
state: Texas
city: Tyler
country: United States
facility: AnaptysBio Investigational Site 10-132
state: Texas
city: Seattle
country: United States
facility: AnaptysBio Investigational Site 10-107
state: Washington
city: Innsbruck
country: Austria
facility: AnaptysBio Investigational Site 12-101
city: Salzburg
country: Austria
facility: AnaptysBio Investigational Site 12-104
city: St. Polten
country: Austria
facility: AnaptysBio Investigational Site 12-103
city: Vienna
country: Austria
facility: AnaptysBio Investigational Site 12-102
city: Sofia
country: Bulgaria
facility: AnaptysBio Investigational Site 61-102
city: London
country: Canada
facility: AnaptysBio Investigational Site 11-102
state: Ontario
city: Montréal
country: Canada
facility: AnaptysBio Investigational Site 11-103
state: Quebec
city: Calgary
country: Canada
facility: AnaptysBio Investigational Site 11-105
city: Rijeka
country: Croatia
facility: AnaptysBio Investigational Site 74-104
city: Zagreb
country: Croatia
facility: AnaptysBio Investigational Site 74-101
city: Nantes
country: France
facility: AnaptysBio Investigational Site 16-102
city: Nantes
country: France
facility: AnaptysBio Investigational Site 16-103
city: Tours
country: France
facility: AnaptysBio Investigational Site 16-101
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-106
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-103
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-102
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-101
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-104
city: Tbilisi
country: Georgia
facility: AnaptysBio Investigational Site 59-105
city: Berlin
country: Germany
facility: AnaptysBio Investigational Site 17-107
city: Brandenburg
country: Germany
facility: AnaptysBio Investigational Site 17-106
city: Dachau
country: Germany
facility: AnaptysBio Investigational Site 17-105
city: Duisburg
country: Germany
facility: AnaptysBio Investigational Site 17-101
city: Erlangen
country: Germany
facility: AnaptysBio Investigational Site 17-110
city: Hamburg
country: Germany
facility: AnaptysBio Investigational Site 17-108
city: Kiel
country: Germany
facility: AnaptysBio Investigational Site 17-103
city: Ulm
country: Germany
facility: AnaptysBio Investigational Site 17-109
city: Bologna
country: Italy
facility: AnaptysBio Investigational Site 20-112
city: Cagliari
country: Italy
facility: AnaptysBio Investigational Site 20-111
city: Catania
country: Italy
facility: AnaptysBio Investigational Site 20-110
city: Legnano
country: Italy
facility: AnaptysBio Investigational Site 20-108
city: Milan
country: Italy
facility: AnaptysBio Investigational Site 20-105
city: Pavia
country: Italy
facility: AnaptysBio Investigational Site 20-107
city: Rozzano
country: Italy
facility: AnaptysBio Investigational Site 20-102
city: San Donato
country: Italy
facility: AnaptysBio Investigational Site 20-109
city: San Giovanni
country: Italy
facility: AnaptysBio Investigational Site 20-104
city: Turin
country: Italy
facility: AnaptysBio Investigational Site 20-113
city: Udine
country: Italy
facility: AnaptysBio Investigational Site 20-106
city: Amsterdam
country: Netherlands
facility: AnaptysBio Investigational Site 21-101
city: Bydgoszcz
country: Poland
facility: AnaptysBio Investigational Site 30-108
city: Częstochowa
country: Poland
facility: AnaptysBio Investigational Site 30-106
city: Elblag
country: Poland
facility: AnaptysBio Investigational Site 30-112
city: Katowice
country: Poland
facility: AnaptysBio Investigational Site 30-102
city: Katowice
country: Poland
facility: AnaptysBio Investigational Site 30-115
city: Kraków
country: Poland
facility: AnaptysBio Investigational Site 30-111
city: Kraków
country: Poland
facility: AnaptysBio Investigational Site 30-123
city: Lublin
country: Poland
facility: AnaptysBio Investigational Site 30-114
city: Poznań
country: Poland
facility: AnaptysBio Investigational Site 30-104
city: Poznań
country: Poland
facility: AnaptysBio Investigational Site 30-117
city: Poznań
country: Poland
facility: AnaptysBio Investigational Site 30-120
city: Rzeszów
country: Poland
facility: AnaptysBio Investigational Site 30-116
city: Sopot
country: Poland
facility: AnaptysBio Investigational Site 30-113
city: Toruń
country: Poland
facility: AnaptysBio Investigational Site 30-110
city: Warsaw
country: Poland
facility: AnaptysBio Investigational Site 30-101
city: Warsaw
country: Poland
facility: AnaptysBio Investigational Site 30-107
city: Warsaw
country: Poland
facility: AnaptysBio Investigational Site 30-109
city: Łódź
country: Poland
facility: AnaptysBio Investigational Site 30-103
city: Łódź
country: Poland
facility: AnaptysBio Investigational Site 30-119
city: Bucharest
country: Romania
facility: AnaptysBio Investigational Site 30-101
city: Cluj-Napoca
country: Romania
facility: AnaptysBio Investigational Site 31-103
city: Timişoara
country: Romania
facility: AnaptysBio Investigational Site 31-102
city: Belgrade
country: Serbia
facility: AnaptysBio Investigational Site 58-103
city: Belgrade
country: Serbia
facility: AnaptysBio Investigational Site 58-105
city: Belgrad
country: Serbia
facility: AnaptysBio Investigational Site 58-101
city: Belgrad
country: Serbia
facility: AnaptysBio Investigational Site 58-104
city: Zrenjanin
country: Serbia
facility: AnaptysBio Investigational Site 58-102
city: Alicante
country: Spain
facility: AnaptysBio Investigational Site 24-102
city: Lleida
country: Spain
facility: AnaptysBio Investigational Site 24-103
city: Belfast
country: United Kingdom
facility: AnaptysBio Investigational Site 27-103
city: Cambridge
country: United Kingdom
facility: AnaptysBio Investigational Site 27-102
city: Liverpool
country: United Kingdom
facility: AnaptysBio Investigational Site 27-106
city: London
country: United Kingdom
facility: AnaptysBio Investigational Site 27-101
city: Runcorn
country: United Kingdom
facility: AnaptysBio Investigational Site 27-105
city: Shrewsbury
country: United Kingdom
facility: AnaptysBio Investigational Site 27-107
city: York
country: United Kingdom
facility: AnaptysBio Investigational Site 27-104
Study officials:
affiliation: AnaptysBio, Inc.
name: Zurab Machaidze, MD
role: STUDY_DIRECTOR
References: