ACTIVE_NOT_RECRUITING

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

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Conditions

Ulcerative ColitisRosnilimabANB030PD-1 agonistROSETTA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-12-04
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06127043

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female ≥18
  2. * Participants with a clinical diagnosis of UC for prior to Day 1
  3. * Subject has moderate to severe, active UC, defined as a mMS ≥ 5 with an endoscopy subscore ≥2
  4. * Subject has had a surveillance colonoscopy that did not detect potential dysplasia or colon cancer performed within 1 year of Day 1.
  5. * 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.)
  1. * Subject has a diagnosis of Crohn's disease or indeterminate colitis.
  2. * Subject has a diagnosis of fulminant colitis and/or toxic megacolon.
  3. * 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).
  4. * Subject has disease limited to the rectum (ulcerative proctitis)
  5. * Subject has a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.
  6. * The subject had prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator.

Contacts and Locations

Principal Investigator

Zurab Machaidze, MD
STUDY_DIRECTOR
AnaptysBio, Inc.

Study Locations (Sites)

AnaptysBio Investigational Site 10-115
Phoenix, Arizona, 85018
United States
AnaptysBio Investigational Site 10-117
Garden Grove, California, 92845
United States
AnaptysBio Investigational Site 10-112
Lancaster, California, 93534
United States
AnaptysBio Investigational Site 10-129
Lancaster, California, 93534
United States
AnaptysBio Investigational Site 10-108
San Jose, California, 95124
United States
AnaptysBio Investigational Site 10-127
Brooksville, Florida, 34601
United States
AnaptysBio Investigational Site 10-106
Miami, Florida, 33165
United States
AnaptysBio Investigational Site 10-109
Miami Gardens, Florida, 33014
United States
AnaptysBio Investigational Site 10-131
Orlando, Florida, 32789
United States
AnaptysBio Investigational Site 10-123
Orlando, Florida, 32822
United States
AnaptysBio Investigational Site 10-125
Tampa, Florida, 33607
United States
AnaptysBio Investigational Site 10-122
Atlanta, Georgia, 30328
United States
AnaptysBio Investigational Site 10-124
Oak Lawn, Illinois, 60453
United States
AnaptysBio Investigational Site 10-118
Las Vegas, Nevada, 89128
United States
AnaptysBio Investigational Site 10-133
Utica, New York, 13501
United States
AnaptysBio Investigational Site 10-136
Cincinnati, Ohio, 45201
United States
AnaptysBio Investigational Site 10-120
Norman, Oklahoma, 73017
United States
AnaptysBio Investigational Site 10-103
Kingsport, Tennessee, 37663
United States
AnaptysBio Investigational Site 10-104
Dallas, Texas, 75246
United States
AnaptysBio Investigational Site 10-113
Garland, Texas, 75044
United States
AnaptysBio Investigational Site 10-135
Georgetown, Texas, 78626
United States
AnaptysBio Investigational Site 10-134
Lubbock, Texas, 79382
United States
AnaptysBio Investigational Site 10-130
Southlake, Texas, 76092
United States
AnaptysBio Investigational Site 10-132
Tyler, Texas, 75701
United States
AnaptysBio Investigational Site 10-107
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: AnaptysBio, Inc.

  • Zurab Machaidze, MD, STUDY_DIRECTOR, AnaptysBio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2026-05

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Rosnilimab
  • ANB030
  • PD-1 agonist
  • ROSETTA

Additional Relevant MeSH Terms

  • Ulcerative Colitis