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A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) - Trial NCT06127043

Access comprehensive clinical trial information for NCT06127043 through Pure Global AI's free database. This Phase 2 trial is sponsored by AnaptysBio, Inc. and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 132 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06127043
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06127043
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A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
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

Study Focus

Ulcerative Colitis

Rosnilimab

Interventional

drug

Sponsor & Location

AnaptysBio, Inc.

Kissimmee,Tampa,Winston-Salem,Kingsport,Dallas, United States of America

Timeline & Enrollment

Phase 2

Dec 04, 2023

May 01, 2026

132 participants

Primary Outcome

Mean change in modified Mayo Score (mMs) from Baseline to Week 12

Summary

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

ICD-10 Classifications

Ulcerative colitis
Other ulcerative colitis
Ulcerative colitis, unspecified
Arthropathy in ulcerative colitis
Juvenile arthritis in ulcerative colitis

Data Source

ClinicalTrials.gov

NCT06127043

Non-Device Trial