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

April 16, 2024 updated by: AnaptysBio, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0101
        • Recruiting
        • AnaptysBio Investigative Site 59-106
      • Tbilisi, Georgia, 0102
        • Recruiting
        • AnaptysBio Investigative Site 59-103
      • Tbilisi, Georgia, 0141
        • Recruiting
        • AnaptysBio Investigative Site 59-102
      • Tbilisi, Georgia, 0160
        • Recruiting
        • AnaptysBio Investigative Site 59-101
      • Tbilisi, Georgia, 0160
        • Recruiting
        • AnaptysBio Investigative Site 59-104
      • Tbilisi, Georgia, 0180
        • Recruiting
        • AnaptysBio Investigative Site 59-105
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Recruiting
        • AnaptysBio Investigative Site 10-115
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • AnaptysBio Investigative Site 10-114
    • California
      • Garden Grove, California, United States, 92845
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-117
      • Lancaster, California, United States, 93534
        • Recruiting
        • AnaptysBio Investigative Site 10-112
      • Los Angeles, California, United States, 90004
        • Recruiting
        • AnaptysBio Investigative Site 10-110
      • San Jose, California, United States, 95124
        • Recruiting
        • AnaptysBio Investigative Site 10-108
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-121
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Recruiting
        • AnaptysBio Investigative Site 10-101
      • Miami, Florida, United States, 33165
        • Recruiting
        • AnaptysBio Investigative Site 10-106
      • Miami Gardens, Florida, United States, 33014
        • Recruiting
        • AnaptysBio Investigative Site 10-109
      • Tampa, Florida, United States, 33609
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-102
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-119
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-118
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • AnaptysBio Investigative Site 10-105
    • Oklahoma
      • Norman, Oklahoma, United States, 73017
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-120
    • Tennessee
      • Kingsport, Tennessee, United States, 37663
        • Recruiting
        • AnaptysBio Investigative Site 10-103
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • AnaptysBio Investigative Site 10-104
      • Garland, Texas, United States, 75044
        • Recruiting
        • AnaptysBio Investigative Site 10-113
    • Washington
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • AnaptysBio Investigative Site 10-107

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
This arm will receive Placebo SC
Drug: Placebo
Administered via SC
Experimental: Rosnilimab SC Dose 1
This arm will receive High dose Rosnilimab SC
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
  • ANB030
Experimental: Rosnilimab SC Dose 2
This arm will receive low dose Rosnilimab SC
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
  • ANB030

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in modified Mayo Score (mMs) from Baseline to Week 12
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving clinical remission at Week 12
Time Frame: Baseline to Week 12
Defined as a mMS ≤ 2, with a stool frequency subscore (SFS) ≤ 1, RBS=0, and endoscopic subscore ≤ 1 without friability.
Baseline to Week 12
Proportion of subjects showing endoscopic treatment improvement at Week 12
Time Frame: Baseline to Week 12
Defined as an endoscopy subscore ≤ 1 without friability.
Baseline to Week 12
Proportion of subjects achieving a clinical response at Week 12
Time Frame: 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.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnaptysBio, Inc.

Investigators

  • Study Director: Zurab Machaidze, MD, 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 Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB030-204 ROSETTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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