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

Summary

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

Timeline

Start

2023-12-04

Primary completion

2026-01

Completion

2026-05

Outcome

Missed primary endpoint

release “lack of adequate efficacy at Week 12 does not support further development of rosnilimab in UC and trial will be discontinued” anaptysbio.com ↗

release “did not meet the primary endpoint of mean change from baseline in modified Mayo Score (mMS) or key secondary endpoints” anaptysbio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rosnilimab	Monoclonal antibody	—	Subcutaneous

Indications