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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Phoenix

AnaptysBio Investigative Site 10-115, Phoenix, Arizona, United States, 85018

Sun City

AnaptysBio Investigative Site 10-114, Sun City, Arizona, United States, 85351

Tucson

AnaptysBio Investigational Site 10-126, Tucson, Arizona, United States, 85724

Garden Grove

AnaptysBio Investigative Site 10-117, Garden Grove, California, United States, 92845

Lancaster

AnaptysBio Investigative Site 10-112, Lancaster, California, United States, 93534

Los Angeles

AnaptysBio Investigative Site 10-110, Los Angeles, California, United States, 90004

Los Gatos

AnaptysBio Investigational Site 10-108A, Los Gatos, California, United States, 95032

San Jose

AnaptysBio Investigative Site 10-108, San Jose, California, United States, 95124

Hamden

AnaptysBio Investigative Site 10-121, Hamden, Connecticut, United States, 06518

Kissimmee

AnaptysBio Investigative Site 10-101, Kissimmee, Florida, United States, 34741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AnaptysBio, Inc.,

Zurab Machaidze, MD, STUDY_DIRECTOR, AnaptysBio, Inc.

Study Record Dates

2026-05