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

NCT06127043 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-10-03

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Rosnilimab

PD-1 agonist antibody

DRUG

Placebo

Administered via SC

Sponsors & Collaborators

  • AnaptysBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Zurab Machaidze, MD · AnaptysBio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-01-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Croatia
  • France
  • Georgia
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127043 on ClinicalTrials.gov