A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)

Phase 2

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: Rosnilimab; Drug: Placebo

• 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).

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Study Start: 2023-12-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosnilimab SC Dose 1	Rosnilimab	This arm will receive High dose Rosnilimab SC
Rosnilimab SC Dose 2	Rosnilimab	This arm will receive low dose Rosnilimab SC
Placebo	Placebo	This arm will receive Placebo 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 (45)

AnaptysBio Investigative Site 10-114; 🇺🇸 Sun City, Arizona, United States

AnaptysBio Investigative Site 59-106; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 10-112; 🇺🇸 Lancaster, California, United States

AnaptysBio Investigational Site 10-122; 🇺🇸 Atlanta, Georgia, United States

AnaptysBio Investigational Site 10-124; 🇺🇸 Oak Lawn, Illinois, United States

AnaptysBio Investigative Site 10-119; 🇺🇸 Hagerstown, Maryland, United States

AnaptysBio Investigative Site 10-103; 🇺🇸 Kingsport, Tennessee, United States

AnaptysBio Investigative Site 10-107; 🇺🇸 Seattle, Washington, United States

AnaptysBio Investigative Site 10-106; 🇺🇸 Miami, Florida, United States

AnaptysBio Investigative Site 10-118; 🇺🇸 Las Vegas, Nevada, United States

AnaptysBio Investigational Site 58-106; 🇷🇸 Novi Sad, Serbia

AnaptysBio Investigational Site 27-107; 🇬🇧 Shrewsbury, United Kingdom

AnaptysBio Investigative Site 10-104; 🇺🇸 Dallas, Texas, United States

AnaptysBio Investigative Site 10-115; 🇺🇸 Phoenix, Arizona, United States

AnaptysBio Investigational Site 10-125; 🇺🇸 Tampa, Florida, United States

AnaptysBio Investigative Site 10-102; 🇺🇸 Tampa, Florida, United States

AnaptysBio Investigational Site 10-123; 🇺🇸 Orlando, Florida, United States

AnaptysBio Investigative Site 10-105; 🇺🇸 Winston-Salem, North Carolina, United States

AnaptysBio Investigative Site 10-117; 🇺🇸 Garden Grove, California, United States

AnaptysBio Investigational Site 10-126; 🇺🇸 Tucson, Arizona, United States

AnaptysBio Investigative Site 10-108; 🇺🇸 San Jose, California, United States

AnaptysBio Investigative Site 10-110; 🇺🇸 Los Angeles, California, United States

AnaptysBio Investigational Site 10-108A; 🇺🇸 Los Gatos, California, United States

AnaptysBio Investigative Site 10-121; 🇺🇸 Hamden, Connecticut, United States

AnaptysBio Investigative Site 10-101; 🇺🇸 Kissimmee, Florida, United States

AnaptysBio Investigative Site 10-109; 🇺🇸 Miami Gardens, Florida, United States

AnaptysBio Investigative Site 10-120; 🇺🇸 Norman, Oklahoma, United States

AnaptysBio Investigative Site 59-102; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-103; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 10-113; 🇺🇸 Garland, Texas, United States

AnaptysBio Investigative Site 59-104; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-105; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-101; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigational Site 58-105; 🇷🇸 Belgrade, Serbia

AnaptysBio Investigational Site 58-103; 🇷🇸 Belgrade, Serbia

AnaptysBio Investigational Site 58-104; 🇷🇸 Belgrad, Serbia

AnaptysBio Investigational Site 58-107; 🇷🇸 Belgrad, Serbia

AnaptysBio Investigative Site 58-101; 🇷🇸 Belgrad, Serbia

AnaptysBio Investigational Site 58-102; 🇷🇸 Zrenjanin, Serbia

AnaptysBio Investigational Site 27-103; 🇬🇧 Belfast, United Kingdom

AnaptysBio Investigative Site 27-102; 🇬🇧 Cambridge, United Kingdom

AnaptysBio Investigational Site 27-106; 🇬🇧 Liverpool, United Kingdom

AnaptysBio Investigative Site 27-101; 🇬🇧 London, United Kingdom

AnaptysBio Investigational Site 27-105; 🇬🇧 Runcorn, United Kingdom

AnaptysBio Investigative Site 27-104; 🇬🇧 York, United Kingdom