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

NCT06127043 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ANB030-204 ROSETTA
• Study Type: interventional
• Target: 132
• Locations: 15 countries
• Sites: 100

Brief Summary

ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)

Conditions

Ulcerative Colitis

Keywords

Rosnilimab; ANB030; PD-1 agonist; ROSETTA

Outcome Measures

Primary Outcomes (1)

• Mean change in modified Mayo Score (mMs) from 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.

  Baseline to Week 12

Secondary Outcomes (3)

• Proportion of subjects achieving clinical remission at Week 12

  Baseline to Week 12

• Proportion of subjects showing endoscopic treatment improvement at Week 12

  Baseline to Week 12

• Proportion of subjects achieving a clinical response at Week 12

  Baseline to Week 12

Study Arms (3)

Rosnilimab SC Dose 1

EXPERIMENTAL

This arm will receive High dose Rosnilimab SC

Drug: Rosnilimab

Rosnilimab SC Dose 2

EXPERIMENTAL

This arm will receive low dose Rosnilimab SC

Drug: Rosnilimab

Placebo

PLACEBO COMPARATOR

This arm will receive Placebo SC

Drug: Placebo

Interventions

Rosnilimab DRUG

PD-1 agonist antibody

Also known as: ANB030

Rosnilimab SC Dose 1; Rosnilimab SC Dose 2

Placebo DRUG

Administered via SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (100)

AnaptysBio Investigational Site 10-115

Phoenix, Arizona, 85018, United States

Location

AnaptysBio Investigational Site 10-117

Garden Grove, California, 92845, United States

Location

AnaptysBio Investigational Site 10-112

Lancaster, California, 93534, United States

Location

AnaptysBio Investigational Site 10-129

Lancaster, California, 93534, United States

Location

AnaptysBio Investigational Site 10-108

San Jose, California, 95124, United States

Location

AnaptysBio Investigational Site 10-127

Brooksville, Florida, 34601, United States

Location

AnaptysBio Investigational Site 10-106

Miami, Florida, 33165, United States

Location

AnaptysBio Investigational Site 10-109

Miami Gardens, Florida, 33014, United States

Location

AnaptysBio Investigational Site 10-131

Orlando, Florida, 32789, United States

Location

AnaptysBio Investigational Site 10-123

Orlando, Florida, 32822, United States

Location

AnaptysBio Investigational Site 10-125

Tampa, Florida, 33607, United States

Location

AnaptysBio Investigational Site 10-122

Atlanta, Georgia, 30328, United States

Location

AnaptysBio Investigational Site 10-124

Oak Lawn, Illinois, 60453, United States

Location

AnaptysBio Investigational Site 10-118

Las Vegas, Nevada, 89128, United States

Location

AnaptysBio Investigational Site 10-133

Utica, New York, 13501, United States

Location

AnaptysBio Investigational Site 10-136

Cincinnati, Ohio, 45201, United States

Location

AnaptysBio Investigational Site 10-120

Norman, Oklahoma, 73017, United States

Location

AnaptysBio Investigational Site 10-103

Kingsport, Tennessee, 37663, United States

Location

AnaptysBio Investigational Site 10-104

Dallas, Texas, 75246, United States

Location

AnaptysBio Investigational Site 10-113

Garland, Texas, 75044, United States

Location

AnaptysBio Investigational Site 10-135

Georgetown, Texas, 78626, United States

Location

AnaptysBio Investigational Site 10-134

Lubbock, Texas, 79382, United States

Location

AnaptysBio Investigational Site 10-130

Southlake, Texas, 76092, United States

Location

AnaptysBio Investigational Site 10-132

Tyler, Texas, 75701, United States

Location

AnaptysBio Investigational Site 10-107

Seattle, Washington, 98195, United States

Location

AnaptysBio Investigational Site 12-101

Innsbruck, Austria

Location

AnaptysBio Investigational Site 12-104

Salzburg, Austria

Location

AnaptysBio Investigational Site 12-103

Sankt Pölten, Austria

Location

AnaptysBio Investigational Site 12-102

Vienna, Austria

Location

AnaptysBio Investigational Site 61-102

Sofia, Bulgaria

Location

AnaptysBio Investigational Site 11-102

London, Ontario, Canada

Location

AnaptysBio Investigational Site 11-103

Montreal, Quebec, Canada

Location

AnaptysBio Investigational Site 11-105

Calgary, Canada

Location

AnaptysBio Investigational Site 74-104

Rijeka, Croatia

Location

AnaptysBio Investigational Site 74-101

Zagreb, Croatia

Location

AnaptysBio Investigational Site 16-102

Nantes, France

Location

AnaptysBio Investigational Site 16-103

Nantes, France

Location

AnaptysBio Investigational Site 16-101

Tours, France

Location

AnaptysBio Investigational Site 59-101

Tbilisi, Georgia, 0160, Georgia

Location

AnaptysBio Investigational Site 59-106

Tbilisi, 0101, Georgia

Location

AnaptysBio Investigational Site 59-103

Tbilisi, 0102, Georgia

Location

AnaptysBio Investigational Site 59-102

Tbilisi, 0141, Georgia

Location

AnaptysBio Investigational Site 59-104

Tbilisi, 0160, Georgia

Location

AnaptysBio Investigational Site 59-105

Tbilisi, 0180, Georgia

Location

AnaptysBio Investigational Site 17-107

Berlin, Germany

Location

AnaptysBio Investigational Site 17-106

Brandenburg, Germany

Location

AnaptysBio Investigational Site 17-105

Dachau, Germany

Location

AnaptysBio Investigational Site 17-101

Duisburg, Germany

Location

AnaptysBio Investigational Site 17-110

Erlangen, Germany

Location

AnaptysBio Investigational Site 17-108

Hamburg, Germany

Location

AnaptysBio Investigational Site 17-103

Kiel, Germany

Location

AnaptysBio Investigational Site 17-109

Ulm, Germany

Location

AnaptysBio Investigational Site 20-112

Bologna, Italy

Location

AnaptysBio Investigational Site 20-111

Cagliari, Italy

Location

AnaptysBio Investigational Site 20-110

Catania, Italy

Location

AnaptysBio Investigational Site 20-108

Legnano, Italy

Location

AnaptysBio Investigational Site 20-105

Milan, Italy

Location

AnaptysBio Investigational Site 20-107

Pavia, Italy

Location

AnaptysBio Investigational Site 20-102

Rozzano, Italy

Location

AnaptysBio Investigational Site 20-109

San Donato, Italy

Location

AnaptysBio Investigational Site 20-104

San Giovanni, Italy

Location

AnaptysBio Investigational Site 20-113

Turin, Italy

Location

AnaptysBio Investigational Site 20-106

Udine, Italy

Location

AnaptysBio Investigational Site 21-101

Amsterdam, Netherlands

Location

AnaptysBio Investigational Site 30-108

Bydgoszcz, Poland

Location

AnaptysBio Investigational Site 30-106

Częstochowa, Poland

Location

AnaptysBio Investigational Site 30-112

Elblag, Poland

Location

AnaptysBio Investigational Site 30-102

Katowice, Poland

Location

AnaptysBio Investigational Site 30-115

Katowice, Poland

Location

AnaptysBio Investigational Site 30-111

Krakow, Poland

Location

AnaptysBio Investigational Site 30-123

Krakow, Poland

Location

AnaptysBio Investigational Site 30-103

Lodz, Poland

Location

AnaptysBio Investigational Site 30-119

Lodz, Poland

Location

AnaptysBio Investigational Site 30-114

Lublin, Poland

Location

AnaptysBio Investigational Site 30-104

Poznan, Poland

Location

AnaptysBio Investigational Site 30-117

Poznan, Poland

Location

AnaptysBio Investigational Site 30-120

Poznan, Poland

Location

AnaptysBio Investigational Site 30-116

Rzeszów, Poland

Location

AnaptysBio Investigational Site 30-113

Sopot, Poland

Location

AnaptysBio Investigational Site 30-110

Torun, Poland

Location

AnaptysBio Investigational Site 30-101

Warsaw, Poland

Location

AnaptysBio Investigational Site 30-107

Warsaw, Poland

Location

AnaptysBio Investigational Site 30-109

Warsaw, Poland

Location

AnaptysBio Investigational Site 30-101

Bucharest, Romania

Location

AnaptysBio Investigational Site 31-103

Cluj-Napoca, Romania

Location

AnaptysBio Investigational Site 31-102

Timișoara, Romania

Location

AnaptysBio Investigational Site 58-101

Belgrade, Serbia

Location

AnaptysBio Investigational Site 58-103

Belgrade, Serbia

Location

AnaptysBio Investigational Site 58-104

Belgrade, Serbia

Location

AnaptysBio Investigational Site 58-105

Belgrade, Serbia

Location

AnaptysBio Investigational Site 58-102

Zrenjanin, Serbia

Location

AnaptysBio Investigational Site 24-102

Alicante, Spain

Location

AnaptysBio Investigational Site 24-103

Lleida, Spain

Location

AnaptysBio Investigational Site 27-103

Belfast, United Kingdom

Location

AnaptysBio Investigational Site 27-102

Cambridge, United Kingdom

Location

AnaptysBio Investigational Site 27-106

Liverpool, United Kingdom

Location

AnaptysBio Investigational Site 27-101

London, United Kingdom

Location

AnaptysBio Investigational Site 27-105

Runcorn, United Kingdom

Location

AnaptysBio Investigational Site 27-107

Shrewsbury, United Kingdom

Location

AnaptysBio Investigational Site 27-104

York, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Zurab Machaidze, MD

  AnaptysBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 4, 2023
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); SE (5); BU (1); DE (8); US (25); FR (3); AU (4); NL (1); CR (2); RO (3); GB (7); CA (3); ES (2); PL (19); IT (11)